protocol_id stringclasses 263
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NCT03453619 | A | 1. 1. 3. P art B L o n g- Ter m E xte nsi o n P h ase: D ose R ati o n ale | A 1. 1. 3. P art B L o n g- Ter m E xte nsi o n P h ase: D ose R ati o n ale T he rati o nale f or t he Part A pe gcet ac o pla n d ose re gi me n is pr o vi de d i n Secti o n 8. 2 . | [] |
NCT03453619 | A | 1. 1. 3. 1. T ar get Le vel of P e gcet a c o pl a n Ser u m C o nce ntr ati o n | A 1. 1. 3. 1. T ar get Le vel of P e gcet a c o pl a n Ser u m C o nce ntr ati o n T he t o xic ol o gical data acc u m ulate d fr o m t he a ni mal st u dies were us e d t o g ui de d ose selecti o n d uri n g t he P hase 1 si n gle asce n di n g d ose a n d m ulti ple asce n di n g d ose st u di es i n healt h y v ol... | [] |
NCT03453619 | A | 1. 1. 3. 2. D osi n g A dj ust m e nt O pti o n | A 1. 1. 3. 2. D osi n g A dj ust m e nt O pti o n Tra nsiti o n fr o m 3 6 0 m g dail y t o 1 0 8 0 m g t wice wee kl y ma y res ult i n a s mall decreas e i n e x p os ure. T heref ore, if a n i ncreas e i n pr otei n uria is o bser ve d u p o n tra nsiti o n t o t wice- wee kl y d osi n g, t he n a n i ncrease i n d ... | [
"A1.1.4. Part B Long-Term Extension Phase: Study Treatments",
"A1.1.4.1. Part B Identity of Investigational Product",
"A1.1.4.2. Part B Pegcetacoplan Dosing",
"A1.1.4.3. Part B Pegcetacoplan Administration",
"A1.1.5. Part B Long-Term Extension Phase: Labeling, Packaging, Storage, and Handling",
"A1.1.5.1.... |
NCT03459131 | P | R O T O C O L S Y N O P SI S | P R O T O C O L S Y N O P SI S D oc u me nt: Versi o n: 2 . 0 ; M o s t - R e c e n t ; E f f e c t i v e ; C U R R E N T T D O C - 0 0 5 4 8 3 8 Pa ge of 4 3 St at us: E f f e c t i v e 0 1- Mar- 2 0 1 8 D oc u me nt: Versi o n: 2 . 0 ; M o s t - R e c e n t ; E f f e c t i v e ; C U R R E N T T D O C - 0 0 5 4 8 3 8 ... | [
"1.1 Abbreviations",
"3 INTRODUCTION",
"3.1 Study Rationale and Purpose",
"3.2 Trial Objective",
"3.3 Risks and Benefits",
"3. 4 S u bject P o p ul ati o n",
"3. 5 O utli ne of St u d y"
] |
NCT03459131 | T | R E A T M E N T S A D MI NI S T E R E D | T R E A T M E N T S A D MI NI S T E R E D S u bjects will be ra n d o mize d i n a 1: 1 ma n ner t o recei ve treat me nt i n cr oss o ver se q ue nce BI O FI N I T Y E N E R G Y S t he n BI O FI N I T Y or I O FI NI T Y t he n BI O FI NI T Y E N E R G Y S , res pecti vely.
4. 1 I de ntit y of St u d y Tr e at me nts ... | [
"4. 1 I de ntit y of St u d y Tr e at me nts",
"4. 2 Acc o u nt a bilit y Pr oce d ures",
"4.3 Local Lens Procurement",
"4.3.1 Procurement",
"4.3.2 Labeling",
"4.3.3 Handling",
"4.3.4 Dispensing and Accountability",
"4.3.5 Final Disposition",
"4. 4 Wo r n Le ns C ollecti o n, St or a g e a n d Ret u... |
NCT03474666 | 1 | INTRODUCTION | 1 INTRODUCTION The Surgical Site Infections (SSI's) are the most frequent healthcare-associated infections and are an important infectious complication in the postoperative period among liver transplantation (LT) recipients (1-3) . SSI incidence among LT recipients, whose allografts were from deceased donors, varied fr... | [] |
NCT03474666 | 2 | RESEARCH OBJECTIVE | 2 RESEARCH OBJECTIVE To evaluate the effects of a postoperative strict blood glucose control protocol comparatively to an institutional protocol on the SSI incidence among LT recipients. | [] |
NCT03474666 | 3 | METHODS | 3 METHODS The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) were used to write this methods chapter(35) . It is a randomized open-label clinical trial, in other words, the researchers will not try to blind the patients(36). Among the research designs, the randomized clinical trial stands o... | [] |
NCT03474666 | 3.1 | STUDY SETTING | 3.1 STUDY SETTING The study will be conducted in a tertiary referral hospital, service provider for Brazilian Public Health System situated in the countryside of São Paulo State. It is an academic and research hospital licensed by Brazilian Ministry of Health to perform LT since 2009; 40 LT are done each year(39) . | [] |
NCT03474666 | 3.2 | ELIGIBILITY CRITERIA | 3.2 ELIGIBILITY CRITERIA Patients eligible for the trial must be 18 years of age or older, recipients of LT whose allograft came from deceased donors. The patients that underwent any kind of surgery with or without prosthesis implant in the 30 days before the LT or are submitted to multiple organ transplantation will b... | [] |
NCT03474666 | 3.3 | SAMPLE SIZE | 3.3 SAMPLE SIZE Based on previous studies that showed the reduction of any infection incidence among LT recipients the sample size was calculated on the basis of the primary hypothesis(16, 40) . 58 patients are required to have an 80% chance of detecting, as significant at the 5% level, a decrease in the primary outcom... | [] |
NCT03474666 | 3.4 | SEQUENCE GENERATION AND CONCEALMENT | 3.4 SEQUENCE GENERATION AND CONCEALMENT Participants will be randomly assigned to either standard control or strict control with a 1:1 allocation as a per computer-generated randomisation schedule; the procedure will be performed by an independent statistician. The randomization schedule will be put into sequentially n... | [] |
NCT03474666 | 3.5 | RECRUITMENT | 3.5 RECRUITMENT All the candidates for LT or representatives, during the ambulatory pre-transplant evaluation in the facility selected to conduct the study, will be contacted by the to check the inclusion and exclusion criteria, as well to explain the possible risks and the benefits of participating in research followi... | [] |
NCT03474666 | 3.6 | ALLOCATION | 3.6 ALLOCATION After the patients' acceptance in participating in the research, in the ICU admission, any bedside blood glucose reading equal or superior to 130 mg/dL in the first 24 hours of the postoperative period will determine the LT recipient's allocation in the study. The sealed opaque envelope will be opened by... | [] |
NCT03474666 | 3.7 | INTERVENTIONS | 3.7 INTERVENTIONS To implement the protocols of glycaemic control, the researcher has established, in an earlier study, a previous relationship with the surgeons and intensive care doctors(13). Consequently, there will be for each LT recipient a medical order of the randomised intervention. | [] |
NCT03474666 | 3.7.1 | STRICT GLYCEMIC CONTROL GROUP | 3.7.1 STRICT GLYCEMIC CONTROL GROUP The strict protocol adopted to conduct the study was proposed by Keegan e Cols.(23) (2010) to be used among adult LT recipients that consists of a continuous intravenous insulin infusion. The targeted blood glucose range is 80-130 mg/dL. The procedure must be stopped when the patient... | [] |
NCT03474666 | 3.8 | STANDARD GLYCEMIC CONTROL GROUP | 3.8 STANDARD GLYCEMIC CONTROL GROUP The control group will be submitted to the standard (targeted BG: 130-180 mg/dL) institutional blood glucose control that is an escalating subcutaneous insulin dose for a given blood glucose reading, as follows: Figure 1 - Subcutaneous insulin scheme. São Paulo, 2017. | Blood glucose... | [] |
NCT03474666 | 3.9 | THE BLOOD GLUCOSE MEASURE | 3.9 THE BLOOD GLUCOSE MEASURE As an institution routine, either the standard group and the strict group will be submitted to a finger prick test each hour by nursing staff, trained by the researcher, under the supervision of a Registered Nurse employing a bedside glucose meter (FreeStyle Precision Pro® Abbott) calibrat... | [] |
NCT03474666 | 3.10 | PRIMARY OUTCOME | 3.10 PRIMARY OUTCOME Surgical site infection following the Centers for Disease Control and Prevention defining criteria: SSI occurs within 30 or 90 days after the operation and involves skin or subcutaneous tissue of the incision, deep soft tissues or organ and spaces, which were opened or manipulated during an operati... | [] |
NCT03474666 | 3.11 | SECONDARY OUTCOMES | 3.11 SECONDARY OUTCOMES The frequency of variables between both groups will be analysed as follows: - Hyperglycaemia > 250 mg/dL(23); - Hypoglycaemia < 60 mg/dL(23); - Time for SSI development; - Time of mechanical ventilation through ICU stay; - ICU stay; - Postoperative ward stay; - Death within 90 days after LT. | [] |
NCT03474666 | 3.12 | EVALUATION OF PRIMARY OUTCOME | 3.12 EVALUATION OF PRIMARY OUTCOME | [] |
NCT03474666 | 3.12.1 | Through hospital stay | 3.12.1 Through hospital stay The researcher will evaluate the surgical wound on alternate days before the dressing changes and patient's bathing. | [] |
NCT03474666 | 3.12.2 | The period following the hospital discharge until the 30th postoperative day | 3.12.2 The period following the hospital discharge until the 30th postoperative day The researcher will contact the liver transplant recipient on alternate days by telephone to detect any signs and symptoms of SSI. Also, the surgical wound will be evaluated every 7 days during the ambulatory doctor's assessment. | [] |
NCT03474666 | 3.12.3 | Evaluation of surgical wound during the hospital stay and after discharge | 3.12.3 Evaluation of surgical wound during the hospital stay and after discharge Facing a suspected SSI case, given the CDC criteria fulfilment, immediately the researcher will communicate with the healthcare team and proceed to register in the nursing records. After that, the researcher will take a picture of the surg... | [] |
NCT03474666 | 3.13 | ADJUDICATION COMMITTEE | 3.13 ADJUDICATION COMMITTEE Will be formed by three health professional experts on SSI diagnosis and treatment. They will evaluate the classification in SSI or non-SSI only for the research purpose. As a result, these procedures will not affect the implementation or not of SSI treatment by the healthcare team. In regar... | [] |
NCT03474666 | 3.14 | SAFETY MONITORING | 3.14 SAFETY MONITORING For unicentric open-labelled clinical trial, the Data Safety Monitoring Inboard is not necessary, following the National Institutes of Health from United States of America statement(41) . However, when 50% of the collected sample is reached the interim analyses will be done by an independent stat... | [] |
NCT03474666 | 3.15 | ETHICAL PROCEDURES | 3.15 ETHICAL PROCEDURES University of Sao Paulo School of Nursing Ethics Committee approved the research proposal (Approval number 2.444.780). All the legal requirements from resolution Nº 466/2012 of Brazilian National Health Council will be followed (43) . The data from donors will be collected from the recipient med... | [] |
NCT03474666 | 3.16 | STATISTICAL ANALYSES PLAN | 3.16 STATISTICAL ANALYSES PLAN A Microsoft Excel for Mac 2011® database will be constructed. The data will be typed into two different files to ensure accuracy by an automated check. Afterwards, the data will be transferred to the software Statistical Package for the Social Sciences® for Windows® version 22.0. The resu... | [] |
NCT03474666 | 4 | SCHEDULE | 4 SCHEDULE | Activity | | Semester/Year | |----------|----------------------------------------------------|--------------------------------| | | Data collection | 1º -2º/2018and 1º/2019 | | | Visitor studentprogram | 2º/2019 | | | Write chapters: results, discussion and conclusion | 1º/2020 | | | Dissertation c... | [] |
NCT03474666 | 5 | REFERENCES | 5 REFERENCES - 1. Berríos-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg [Internet]. 2017 [cited 2017 Oct 19th]; 152(8):[784-91 pp.]. Available from: https://www.ncbi.nlm.nih.gov/p... | [] |
NCT03541356 | 1 | BACKGROUND AND INTRODUCTION | 1. BACKGROUND AND INTRODUCTION | [] |
NCT03541356 | 1.1 | Introduction | 1.1. Introduction The purpose of this study is to evaluate the INP103 drug-device combination product specifically as it pertains to the intranasal administration of L-dopa (levodopa; L-3,4-dihydroxyphenylalanine) to the upper nasal cavity using the I231 Precision Olfactory Delivery (POD) device. L-dopa is the immediat... | [] |
NCT03541356 | 1.2 | Summary of Non-Clinical and Clinical Studies | 1.2. Summary of Non-Clinical and Clinical Studies | [] |
NCT03541356 | 1.2.1 | Non-Clinical Studies | 1.2.1. Non-Clinical Studies Oral L-dopa has been extensively used in the treatment of PD and is supported by a literature evidence base. A review of literature is provided in the Investigator's Brochure. In addition, Impel NeuroPharma has performed the following studies: x Six studies in the cynomolgus monkey examined ... | [] |
NCT03541356 | 1.2.2 | Clinical Studies | 1.2.2. Clinical Studies This is the first Impel sponsored clinical study using INP103. | [] |
NCT03541356 | 1.3 | Summary of Potential Risks and Benefits | 1.3. Summary of Potential Risks and Benefits The risk/benefit profile of L-dopa in combination with benserazide is well known and is described in the Madopar® prescribing information. Similarly, the risk/benefit profile of L-dopa plus carbidopa is well described in the Sinemet® prescribing information. Inhaled formulat... | [] |
NCT03541356 | 1.4 | Dosage and Treatment Periods | 1.4. Dosage and Treatment Periods Dosage will be in five placebo-controlled cohorts: | Cohort | Treatment (Study Drug) | |--------|---------------------------------------------------------------------------------------------------------| | 1 | INP103 35 mg L-dopa (n=6); (1 POD actuation) or Placebo (n=2) | | 2 | INP103... | [] |
NCT03541356 | 1.5 | Study Population | 1.5. Study Population This study will be conducted in PD patients who are responsive to L-dopa and who meet all of the inclusion criteria and none of the exclusion criteria. Safety, tolerability, PK and PDyn parameters will be assessed. | [] |
NCT03541356 | 1.6 | Ethical Principles | 1.6. Ethical Principles This study will be conducted in accordance with the principles of the current Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects), and with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (200... | [] |
NCT03541356 | 2 | OBJECTIVES | 2. OBJECTIVES | [] |
NCT03541356 | 2.1 | Primary Objectives | 2.1. Primary Objectives The primary objective of the study is: x To compare the safety and tolerability of intranasal single doses of INP103 in the presence of a DCI with PD during an OFF episode | [] |
NCT03541356 | 2.2 | Secondary Objectives | 2.2. Secondary Objectives The secondary objectives of the study are: - 1. To characterize the PK of single doses of INP103 - 2. To explore the effect of single doses of INP103 versus placebo on motor function - 3. To explore the PK/PDyn relationship of single doses of INP103 and motor function | [] |
NCT03541356 | 3 | STUDY DESIGN | 3. STUDY DESIGN This is a Phase IIa randomized, double-blind, placebo controlled study to compare the safety and PK/PDyn of L-dopa following administration of INP103 in the presence of a DCI to that of placebo to PD patients during an OFF episode. See [Figure 1](#page-40-0) for a study design flow chart. Subjects will ... | [] |
NCT03541356 | 3.1 | Primary Endpoints | 3.1. Primary Endpoints Safety and tolerability, including the assessment of physical examinations (including nasal inspection), electrocardiograms (ECGs), vital signs (including supine and standing blood pressure, all other vital signs supine only), clinical laboratory results, and AEs (specifically, levodopa induced d... | [] |
NCT03541356 | 3.2 | Secondary Endpoints | 3.2. Secondary Endpoints - 1. PK profile of L-dopa (and carbidopa in Cohort 4) for 120 minutes following dosing (AUC0-2h, Cmax and Tmax) - 2. Motor function, evaluated as: - x Change from baseline to 30 minutes post-dose in MDS-UPDRS Part III score (primary motor function endpoint) - x Change from baseline to 15, 45, 6... | [] |
NCT03541356 | 4 | STUDY POPULATION | 4. STUDY POPULATION | [] |
NCT03541356 | 4.1 | Description of Numbers | 4.1. Description of Numbers At least thirty-two (32) (maximum 36) L-dopa-responsive PD patients will be randomized into the study. | [] |
NCT03541356 | 4.2 | Inclusion Criteria | 4.2. Inclusion Criteria Subjects who meet all of the following criteria will be considered for inclusion in the study: - 1. Adult males and females, 40 to 80 years of age (inclusive) at the time of Screening (Visit 1) - 2. Diagnosed with Idiopathic PD (per UK Brain Bank Criteria) with Modified Hoehn & Yahr (H&Y) Stage ... | [] |
NCT03541356 | 4.3 | Exclusion Criteria | 4.3. Exclusion Criteria The presence of any of the following criteria will constitute cause for the exclusion of the subject: - 1. Severe dyskinesia (defined as per MDS-UPDRS) during a 'normal day' that would significantly interfere with the subject's ability to perform study assessments - 2. In receipt of L-dopa conta... | [] |
NCT03541356 | 4.4 | Contraceptive Requirements | 4.4. Contraceptive Requirements Female subjects of childbearing potential must not become pregnant and must use two methods of adequate contraceptive during the study. Adequate contraception is defined as complete abstinence or a condom AND one other form of the following: - x Birth control pills (The Pill) - x Depo Sh... | [] |
NCT03541356 | 4.5 | Concomitant Medication | 4.5. Concomitant Medication All medications including over-the-counter medications and herbal supplements will be recorded and reviewed by the Investigator. Prior and concomitant medications will be recorded by their generic name and will be coded using the most current World Health Organization (WHO) drug dictionary. ... | [] |
NCT03541356 | 4.6 | Diet, Activity and Other Restrictions | 4.6. Diet, Activity and Other Restrictions Subjects will refrain from consumption of alcohol for 24 hours before INP103 or placebo dosing and for the duration of the study. Subjects should not consume food or drink containing grapefruit juice within 14 days prior to initial dosing and during the entire study. INP103 or... | [] |
NCT03541356 | 4.7 | Meal Schedule | 4.7. Meal Schedule Subjects who arrive at the study site the evening prior to dosing will receive a standard meal and snacks. All subjects will be offered, and encouraged to consume, a light breakfast in the morning 30 minutes prior to dosing. This is 30 minutes prior to dosing with normal PD medications in Visit 2 and... | [] |
NCT03541356 | 5 | STUDY MEDICATION | 5. STUDY MEDICATION | [] |
NCT03541356 | 5.1 | Investigational Product Identification | 5.1. Investigational Product Identification INP103 is a drug-device combination product where the drug component is L-dopa and the device component is the I231 POD Device. The I231 POD Device is a handheld, manually actuated, dose administration device intended to deliver a powder drug formulation to the nasal cavity (... | [] |
NCT03541356 | 5.1.1 | Placebo | 5.1.1. Placebo Placebo will be microcrystalline cellulose. Microcrystalline cellulose is a fine white powder (similar to L-dopa with or without carbidopa) and will come packed and labelled as per identical capsules to those used for INP103 with or without carbidopa. Similar to INP103, placebo will be delivered using th... | [] |
NCT03541356 | 5.2 | Randomization | 5.2. Randomization At least thirty-two (32), maximum 36, subjects will be randomized, and as this is a multi-centre study, centralized randomization will be performed. Treatment assignment will be randomised by blocks of 4 in sequential cohorts, with subjects assigned to either INP103 with or without carbidopa, or plac... | [] |
NCT03541356 | 5.3 | Blinding | 5.3. Blinding This is a double-blind, randomized, placebo-controlled study. Doses of INP103 and placebo will be prepared by pharmacy personnel who will not be involved in the study assessments. Doses will be provided to blinded study personnel for administration. | [] |
NCT03541356 | 5.4 | Dosage and Treatment | 5.4. Dosage and Treatment | [] |
NCT03541356 | 5.4.1 | Study Supplies | 5.4.1. Study Supplies Impel NeuroPharma will supply all INP103, oral benserazide, and placebo product through a third-party vendor, PCI Pharma Services (formerly known as Pharmaceutical Packaging Professionals, or PPP), to the investigational sites. INP103 (with and without carbidopa), benserazide, and placebo supplies... | [] |
NCT03541356 | 5.4.2 | Storage, Dispensing and Investigational Product Accountability | 5.4.2. Storage, Dispensing and Investigational Product Accountability Upon receipt at the investigational site, INP103, benserazide and placebo must be stored at controlled room temperature in light-resistant containers (not refrigerated or frozen), as specified in the pharmacy manual. A record will be maintained by th... | [] |
NCT03541356 | 6 | STUDY PROCEDURES | 6. STUDY PROCEDURES Study visits should be completed as indicated in the Study Schedule located in [Table 1.](#page-25-1) Blood samples for L-dopa PK should be collected at the time points and within the windows designated in [Table 1](#page-25-1) Sites should prioritise in the following order: PK blood draws; UPDRS/Dy... | [] |
NCT03541356 | 6.1 | Medical History | 6.1. Medical History Medical history will be recorded at Screening (Visit 1). | [] |
NCT03541356 | 6.2 | Demographics | 6.2. Demographics Date of birth, age (calculated), sex, ethnicity, and race will be recorded at Screening (Visit 1). | [] |
NCT03541356 | 6.3 | Body Weight and Height/ Body Mass Index | 6.3. Body Weight and Height/ Body Mass Index Body mass index (BMI) is calculated by dividing the subject's body weight in kilograms by the subject's height in meters squared (BMI = kg/m2 ). Body height (centimetres) and body weight (kilograms) will be measured at Screening (Visit 1). Body weight and height will be obta... | [] |
NCT03541356 | 6.4 | Safety Assessments | 6.4. Safety Assessments This study primarily assesses the safety and tolerability of INP103. Safety will be determined by evaluating Physical Examination findings, ECGs, vital signs, clinical laboratory parameters, concomitant medication usage and AEs. If deemed necessary, additional safety measurements will be perform... | [] |
NCT03541356 | 6.4.1 | Nasal Inspection | 6.4.1. Nasal Inspection Nasal inspection will be performed before and after the single dose at times noted in [Table 1](#page-25-1) and on an ongoing basis throughout the study. Any signs of inflammation, ulceration, contact bleeding, oedema, or other abnormalities will be reported. | [] |
NCT03541356 | 6.4.2 | Overall Dyskinesia Assessment | 6.4.2. Overall Dyskinesia Assessment Following dosing with INP103 or placebo, at each inquiry into AEs, or when conducting the MDS-UPDRS Part III assessment, the Investigator or suitably trained designee (who is familiar with rating dyskinesias), must assess the overall level of dyskinesia, based on the scale below. Th... | [] |
NCT03541356 | 6.4.3 | Physical Examination | 6.4.3. Physical Examination Complete physical examinations will be performed by a licensed physician at the time-points specified in [Table 1.](#page-25-1) Complete physical examinations include: general appearance, head, ears, eyes, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremi... | [] |
NCT03541356 | 6.4.4 | Mini Mental Status Examination (MMSE) | 6.4.4. Mini Mental Status Examination (MMSE) Subjects should have an MMSE score of >25 documented within the previous 36 months. If MMSE score is not available, the assessment should be conducted by the Investigator during Screening to confirm eligibility. | [] |
NCT03541356 | 6.4.5 | Vital Signs | 6.4.5. Vital Signs Subjects should be resting in a supine position for at least 3 minutes prior to and during vital signs measurement obtained. Blood pressure, heart rate, respiration rate and temperature should be measured when the subject is supine. Immediately following supine vital signs assessments, blood pressure... | [] |
NCT03541356 | 6.4.6 | Electrocardiogram Monitoring | 6.4.6. Electrocardiogram Monitoring A 12-lead ECG will be taken at the time-points delineated in [Table 1.](#page-25-1)Table 1ECGs (heart rate, PR, RR, RS, QRS, QT and assessment of clinical significance of abnormalities) will be performed with subjects in a recumbent position. Subjects must be in this position for at ... | [] |
NCT03541356 | 6.4.7 | Laboratory Investigations | 6.4.7. Laboratory Investigations Safety laboratory tests (haematology, serum chemistry, and urinalysis [UA]) will be performed at the time-points specified in [Table 1](#page-25-1)and analysed by an appropriately certified central laboratory. Medically indicated laboratory tests (emergency or unscheduled tests) should ... | [] |
NCT03541356 | 6.4.7.1 | Haematology and Serum Chemistry | 6.4.7.1. Haematology and Serum Chemistry A blood sample will be taken from each subject for haematology and serum chemistry analysis at the time-points delineated in[Table 1](#page-25-1) (see [Appendices 1](#page-83-1) and [2](#page-84-1) for parameters to be tested). Additional clinical laboratory tests may be perform... | [] |
NCT03541356 | 6.4.7.2 | Urinalysis | 6.4.7.2. Urinalysis A urinalysis test (dipstick) will be performed for each subject by a central laboratory. Urine analysis will be performed at Screening (Visit 1), and when the subject is admitted to the institution on Day 0 and other times according to the Study Schedule (see [Appendix 3](#page-85-1) for parameters ... | [] |
NCT03541356 | 6.4.8 | MDS-UPDRS | 6.4.8. MDS-UPDRS A full MDS-UPDRS (Parts I-IV) will be assessed at Visit 1 (screening) and on arrival at clinic for dopaminergic responsiveness assessment (Visit 2). Subjects will omit their usual anti PD medication from 22:00 the previous evening and should arrive at the clinic for both Visits 2 and 3 in an OFF state.... | [] |
NCT03541356 | 6.4.9 | Subject Questionnaire | 6.4.9. Subject Questionnaire At 120 up to 180 minutes after dosing with INP103 or placebo, subjects will be asked the questions in the questionnaire provided in [Appendix 6.](#page-88-1) This should follow all other assessments. | [] |
NCT03541356 | 6.5 | Pharmacokinetic Assessments | 6.5. Pharmacokinetic Assessments | [] |
NCT03541356 | 6.5.1 | Sampling and Processing | 6.5.1. Sampling and Processing An intravenous cannula will be inserted prior to all medication dosing at Visit 3 to enable baseline PK and subsequent blood draws to be performed. Blood samples for PK analysis of L-dopa (and carbidopa in Cohort 4) will be obtained, according to the site's SOPs, within 15 minutes prior t... | [] |
NCT03541356 | 6.5.2 | Analytical Methods | 6.5.2. Analytical Methods Plasma PK sample analyses will be performed using validated procedures and methods at AIT Bioscience. | [] |
NCT03541356 | 6.6 | Pharmacodynamic Assessments | 6.6. Pharmacodynamic Assessments | [] |
NCT03541356 | 6.6.1 | MDS-UPDRS | 6.6.1. MDS-UPDRS See [Section 6.4.8.](#page-52-1) | [] |
NCT03541356 | 6.6.2 | Assessment of ON | 6.6.2. Assessment of ON Subjects will provide a self-assessment of their ON or OFF state, and Investigators will provide an assessment of the ON or OFF state of the subject, at the time points delineated in the Study Schedule in [Table 1](#page-25-1). | [] |
NCT03541356 | 7 | STUDY SCHEDULE | 7. STUDY SCHEDULE | [] |
NCT03541356 | 7.1 | Screening (Up to 21 Days Prior to Visit 3 Dosing) (Visit 1) | 7.1. Screening (Up to 21 Days Prior to Visit 3 Dosing) (Visit 1) (Refer also to study synopsis and [Table 1\)](#page-25-1) Prior to enrolling in the study, and before performing any study-related procedures, potential subjects will attend the first of two Screening Visits, at which time they will be provided with full ... | [] |
NCT03541356 | 7.2 | Admission to Clinic (Day prior to Visit 2 and Visit 3) | 7.2. Admission to Clinic (Day prior to Visit 2 and Visit 3) Depending on private arrangements, capability, and logistics, subjects may be domiciled in the study clinic from the evenings prior to Visit 2 and Visit 3. Subjects will receive a standard meal and snacks and be offered a light breakfast in the morning before ... | [] |
NCT03541356 | 7.3 | Evaluation of Dopamine Responsiveness (Screening [Visit 2]) | 7.3. Evaluation of Dopamine Responsiveness (Screening [Visit 2]) Subjects considered eligible for study participation as per the outcome of Screening (Visit 1) are to return to the study clinic for Screening (Visit 2) on one day between Screening Visit 1 and Day 0 (Visit 3), i.e. within the maximum 21-day Screening win... | [] |
NCT03541356 | 7.4 | Dosing and Admission to Clinic (Day 0) (Visit 3) | 7.4. Dosing and Admission to Clinic (Day 0) (Visit 3) | [] |
NCT03541356 | 7.4.1 | Before Dosing | 7.4.1. Before Dosing Subjects not domiciled in the study clinic on the evening of Day -1 will be transported to the study clinic as early as possible on the morning of Day 0. All subjects, irrespective of date or time of arrival at the study clinic, will have their usual anti-PD medication (e.g. usual regular Madopar® ... | [] |
NCT03541356 | 7.4.2 | Dosing (Visit 3) | 7.4.2. Dosing (Visit 3) Subjects will be dosed by delegated clinic staff and according to the treatment arm to which they have been randomized. Additional details about the preparation and dosing of INP103 or placebo are provided in the Pharmacy Manual. | [] |
NCT03541356 | 7.4.3 | After Dosing | 7.4.3. After Dosing The subjects will remain in the study clinic post-dose through to the completion of all scheduled post-dose procedures 240 minutes after dosing. The subject's usual rescue (anti-OFF [e.g. Madopar rapid]) medication will be permitted from 120 minutes post-dose (once all 120 minute assessments have be... | [] |
NCT03541356 | 7.5 | Follow-Up/End of Study (Day 7 + 2 days) | 7.5. Follow-Up/End of Study (Day 7 + 2 days) The subjects will return to the institution on Day 7 (+2 days). In exceptional circumstances, if a subject is unable to attend the end of study visit on Day 7 (+ 2 days, as indicated), the Investigator (or qualified designee) should discuss appropriate re-scheduling to a max... | [] |
NCT03541356 | 8 | ADVERSE EVENTS | 8. ADVERSE EVENTS In this study, AEs will be reported for all subjects from signing of consent until the completion of the end of study Day 7 follow-up visit. SAEs will be reported in all subjects (enrolled and not enrolled) from the time of consent. Treatment-emergent AEs (TEAEs) will be reported from dosing on Day 0.... | [] |
NCT03541356 | 8.1 | Safety Monitoring Committee | 8.1. Safety Monitoring Committee Once dosing has been completed for all subjects in Cohort 1, a Safety Monitoring Committee (composed of the Principal Investigators, the contract research organization (CRO)'s Medical Monitor and the Sponsor's Medical Monitor) will review the AEs reported for the completed cohort. If th... | [] |
NCT03541356 | 8.2 | Definition of an Adverse Event | 8.2. Definition of an Adverse Event An AE is any event, side-effect, or other untoward medical occurrence that occurs in conjunction with the use of a medicinal product in humans, whether or not considered to have a causal relationship to this treatment. An AE can, therefore, be any unfavourable and unintended sign (th... | [] |
NCT03541356 | 8.2.1 | Severity of an Adverse Event | 8.2.1. Severity of an Adverse Event Severity of adverse events will be graded by the Investigator as one of: - x Mild: A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living - x Moderate: A t... | [] |
NCT03541356 | 8.2.2 | Causal Relationship of an Adverse Event | 8.2.2. Causal Relationship of an Adverse Event The Investigator will assess the relationship between INP103 or placebo and the occurrence of each AE. The Investigator's assessment of the relationship of each AE to investigational product will be recorded in the source documents and the eCRF. Alternative causes, such as... | [] |
NCT03541356 | 8.2.3 | Action Taken with Study Medications | 8.2.3. Action Taken with Study Medications Action taken with study medications will be recorded on the AE eCRF page, as one of the following options: - x Dose Interrupted - x Dose Withdrawn - x Not Applicable - x Unknown | [] |
NCT03541356 | 8.2.4 | Outcome | 8.2.4. Outcome Outcome of an AE will be recorded on the AE eCRF as follows: x Recovered / Resolved - x Recovering / Resolving - x Recovered / Resolved with Sequelae - x Not Recovered / Not Resolving - x Fatal - x Unknown | [] |
NCT03541356 | 8.3 | Definition of a Serious Adverse Event | 8.3. Definition of a Serious Adverse Event An SAE is any untoward medical occurrence that at any dose: - x Results in death - x Is life-threatening - x Requires inpatient hospitalization or prolongation of existing hospitalization - x Results in persistent or significant disability/incapacity, or - x Is a congenital an... | [] |
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