protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT03541356 | 8.3.1 | Notification of a Serious Adverse Event | 8.3.1. Notification of a Serious Adverse Event In order to meet the requirements for expedited reporting of SAEs meeting specific requirements to applicable regulatory authorities and institutional ECs, all SAEs, must be reported to CNS within 24 hours from the time the site investigational team first become aware of t... | [
"Safety@clinical.net.au"
] |
NCT03541356 | 8.4 | Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events and Serious Adverse Events | 8.4. Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events and Serious Adverse Events Abnormal laboratory findings (e.g., clinical chemistry, haematology, and urinalysis) or other abnormal assessments (e.g., ECG and vital signs) per se are not reported as AEs. However, those abnormal findin... | [] |
NCT03541356 | 8.5 | Documenting Adverse Events | 8.5. Documenting Adverse Events Any AE occurrence during the study must be documented in the subject's medical records in accordance with the Investigator's normal clinical practice and on the AE page of the eCRF. SAEs that occur during the study must be documented in the subject's medical record, on the AE eCRF, and o... | [] |
NCT03541356 | 8.6 | Regulatory Authorities | 8.6. Regulatory Authorities The reporting of any SAEs to applicable regulatory authorities will be the responsibility of the Sponsor in compliance with applicable country regulations. All SAEs must be reported to the HREC by the Investigator in accordance with their regulations. | [] |
NCT03541356 | 8.7 | Follow-Up of Adverse Events and Serious Adverse Events | 8.7. Follow-Up of Adverse Events and Serious Adverse Events All AEs and SAEs that are deemed related, possibly related or probably related to INP103 or placebo must be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the subject dies or is lost to follow-up. Th... | [] |
NCT03541356 | 8.8 | Pregnancy | 8.8. Pregnancy Females who are pregnant, planning a pregnancy or lactating are to be excluded from the study. In the case of a pregnancy occurring during study participation or at any time during the 30 days following INP103 or placebo, it must be reported using a clinical trial pregnancy form. To ensure subject safety... | [] |
NCT03541356 | 9 | STUDY COMPLETION AND DISCONTINUATION | 9. STUDY COMPLETION AND DISCONTINUATION | [] |
NCT03541356 | 9.1 | Subject Withdrawal | 9.1. Subject Withdrawal In accordance with applicable regulations, a subject has the right to withdraw from the study at any time and for any reason, without prejudice to his future medical care. Subjects may be withdrawn from the study for any of the following reasons: - x Subject is unable or unwilling to continue pa... | [] |
NCT03541356 | 9.2 | Subject Replacement | 9.2. Subject Replacement At least thirty-two subjects are planned for enrolment in the study. Subjects who consent but then do not receive INP103 or placebo for any reason may be replaced at the Sponsor's discretion. Subjects will not be replaced once dosed. | [] |
NCT03541356 | 10 | TERMINATION OR SUSPENSION OF THE STUDY | 10. TERMINATION OR SUSPENSION OF THE STUDY The Sponsor, Investigator, and the HREC reserve the right to terminate or suspend the study at any time; however, this should be discussed between the relevant parties beforehand and the reason for such decision recorded. Should this occur, all data available will also be reco... | [] |
NCT03541356 | 11 | STUDY MONITORING AND DATA MANAGEMENT | 11. STUDY MONITORING AND DATA MANAGEMENT | [] |
NCT03541356 | 11.1 | Study Monitoring | 11.1. Study Monitoring The Sponsor has appointed Clinical Network Services (CNS) Pty Ltd to manage and monitor the study so as to assure them of the adequate conduct of the study and to act as the contact with the investigational site. A study monitor will be identified and will be responsible for liaison with, and sup... | [] |
NCT03541356 | 11.2 | Access to the Study | 11.2. Access to the Study The Sponsor, study monitor, HREC and applicable regulatory agencies may require access to all study documents held at the investigational site, as well as access to all members of the investigational site personnel. It is expected that such access would normally be arranged by agreement with t... | [] |
NCT03541356 | 11.3 | Source Document and Data Verification | 11.3. Source Document and Data Verification The study monitor will visit the investigational site periodically where s/he shall: - x Meet with the Investigator and any other applicable site staff. - x Inspect the eCRFs throughout the study to verify adherence to the protocol; completeness, accuracy, and consistency of ... | [] |
NCT03541356 | 11.4 | Data Management | 11.4. Data Management All data will be recorded in individual source documents. An eCRF will be created by the data management group for recording of the required data in the study database. All eCRF information is to be filled in by site staff. If an item is not available or is not applicable, this fact should be indi... | [] |
NCT03541356 | 12 | STATISTICAL ANALYSES | 12. STATISTICAL ANALYSES This protocol section describes the statistical analyses as they are foreseen at the time of planning the study. A separate Statistical Analysis Plan (SAP) will be prepared prior to performing any unblinded analysis. The SAP will serve as a complement to the study protocol and supersedes it in ... | [] |
NCT03541356 | 12.1 | Sample Size Calculation | 12.1. Sample Size Calculation Thirty-two (32) subjects (8 per dose group) are considered sufficient for assessment of safety and tolerability of SADs of INP103. However, we are proposing that Cohort 4 may enrol an additional 4 patients (for a maximum of 12) under the same randomization scheme (3:1). With at least eight... | [] |
NCT03541356 | 12.2 | Analysis Populations | 12.2. Analysis Populations Safety Population: All subjects who receive any amount of INP103 or placebo will be included in the Safety Population. A pooled placebo group (of subjects from each of the five cohorts) will be used for comparisons. The data will be analysed according to the treatment received. Benserazide Sa... | [] |
NCT03541356 | 12.3 | Safety Analysis | 12.3. Safety Analysis Continuous safety data will be summarised with descriptive statistics (arithmetic mean, SD, median, minimum, and maximum) by treatment. Categorical safety data will be summarised with frequency counts and percentages by treatment. AEs will be coded using the most current Medical Dictionary for Reg... | [] |
NCT03541356 | 12.4 | Pharmacokinetic Analysis | 12.4. Pharmacokinetic Analysis The levodopa concentrations will be summarized with descriptive statistics (arithmetic and geometric mean, SD, median, minimum, and maximum) by treatment group and time point. In addition, the PK parameters (AUC0-0.5h, AUC0-1h, AUC0-2h, Cmax, Tmax) will be summarized with descriptive stat... | [] |
NCT03541356 | 12.5 | Pharmacodynamic Analysis | 12.5. Pharmacodynamic Analysis The changes from baseline in MDS-UPDRS Part III scores will be summarized by treatment groups and estimated using a Mixed Model for Repeated Measures (MMRM) with treatment group (INP103 35 mg, INP103 70 mg, INP103 140 mg, INP103 70mg with 7.0 mg carbidopa, or placebo), time point (15, 30,... | [] |
NCT03541356 | 12.6 | Pharmacokinetic/Pharmacodynamic relationship | 12.6. Pharmacokinetic/Pharmacodynamic relationship The analyses required to investigate the PK/PDyn relationship of INP103 will be defined in the SAP which will be completed before the database is locked. | [] |
NCT03541356 | 13 | REGULATORY REQUIREMENTS | 13. REGULATORY REQUIREMENTS | [] |
NCT03541356 | 13.1 | Regulatory Approvals | 13.1. Regulatory Approvals CNS will act as the legal Australian Representative for Impel NeuroPharma, the Sponsor of the study, and will fulfil the obligations that this role entails. CNS shall, to the extent required by the applicable laws and regulations, interact with Australian Therapeutic Goods Administration (TGA... | [] |
NCT03541356 | 13.2 | Human Research Ethics Committee (HREC) Approval | 13.2. Human Research Ethics Committee (HREC) Approval Prior to the commencement of the study, written approval will be required by the relevant institutional HREC responsible for the investigational site. | [] |
NCT03541356 | 13.3 | Subject Informed Consent | 13.3. Subject Informed Consent It is the Investigator's responsibility to ensure that each subject gives informed consent to participate in the study. The Investigator will explain the nature of the study, its purpose, procedures, expected duration, and the potential benefits, risks and inconveniences in participation.... | [] |
NCT03541356 | 13.4 | Data Protection | 13.4. Data Protection Subjects will be informed that data will be held on file by Impel and that these data may be viewed by staff including the study monitor and by external auditors on behalf of Impel and appropriate regulatory authorities. Subjects will also be informed that a study report will be prepared and may b... | [] |
NCT03541356 | 14 | ADMINISTRATIVE PROCEDURES | 14. ADMINISTRATIVE PROCEDURES | [] |
NCT03541356 | 14.1 | Liability/Indemnity/Insurance | 14.1. Liability/Indemnity/Insurance The study Sponsor will ensure sufficient insurance is available to enable it to indemnify and hold the Investigator(s) and relevant staff as well as any hospital, institution, EC or the like, harmless from any claims for damages for unexpected injuries, including death, that may be c... | [] |
NCT03541356 | 14.2 | Recording of Data and Retention of Records | 14.2. Recording of Data and Retention of Records All source data, clinical records and laboratory data relating to the study will be archived for 15 years after the completion of the study. All data will be available for retrospective review or audit. Source documents are original documents, data, and records from whic... | [] |
NCT03541356 | 14.3 | Publication of Results | 14.3. Publication of Results Publication and reporting of results and outcomes of this trial will be accurate and honest, undertaken with integrity and transparency and in accordance with Impel's Publication Policy. Publication of results will be subjected to fair peer-review. Authorship will be discussed between resea... | [] |
NCT03541356 | 14.4 | Disclosure and Confidentiality | 14.4. Disclosure and Confidentiality By signing this protocol, the Investigator agrees to keep all information provided by the Sponsor in strict confidence and to request similar confidentiality from his/her staff and the local EC. Study documents provided by the Sponsor (protocol, IB, eCRFs, etc.) will be stored appro... | [] |
NCT03541356 | 15 | QUALITY CONTROL AND QUALITY ASSURANCE | 15. QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT03541356 | 15.1 | Compliance with Good Clinical Practice | 15.1. Compliance with Good Clinical Practice The study will be carried out in accordance with the current version of the Declaration of Helsinki, concerning medical research in humans (Ethical Principles for Medical Research Involving Human Subjects), ICH harmonised tripartite guideline for GCP (ICH GCP) 1996 adopted b... | [] |
NCT03541356 | 15.2 | Archiving and Regulatory Inspection | 15.2. Archiving and Regulatory Inspection All study-related documents and records are to be retained for a minimum of 15 years after trial completion. Written agreement from the Sponsor must precede destruction of the same. In accordance with ICH GCP, this study may be selected for audit. Inspection of site facilities ... | [] |
NCT03541356 | 16 | CLINICAL STUDY REPORT | 16. CLINICAL STUDY REPORT A clinical study report will be prepared with reference to ICH Guidance E3 to include: - x Details of where the study was carried out - x Dates of the start and completion of each period of the study - x Details of the investigational product and a statement of production will be provided by I... | [] |
NCT03541356 | 17 | SPONSOR AND INVESTIGATOR OBLIGATIONS | 17. SPONSOR AND INVESTIGATOR OBLIGATIONS | [] |
NCT03541356 | 17.1 | Protocol Amendments | 17.1. Protocol Amendments Neither the Investigator nor the Sponsor will modify or alter this protocol without the agreement of the other. All agreed protocol amendments will be clearly recorded on a protocol amendment form and will be signed and dated by the original protocol approving signatories. All protocol amendme... | [] |
NCT03541356 | 17.2 | Protocol Deviations | 17.2. Protocol Deviations Should any significant protocol deviation occur, it must be reported to the study monitor as soon as is reasonably practical. The deviation and the reason for its occurrence must be documented, reported to the relevant HREC (if required) and included in the study report. Protocol deviations ar... | [] |
NCT03541356 | 18 | REFERENCES | 18. REFERENCES - 1. Tolosa E, Marti MJ, Valldeoriola F, Molinuevo JL. History of levodopa and dopamine agonists in Parkinson's disease treatment. Neurology. 1998 Jun;50(6 Suppl 6):S2-10; discussion S44-48. - 2. Lochhead JJ, Thorne RG. Intranasal delivery of biologics to the central nervous system. Adv Drug Deliv Rev. 2... | [
"APPENDIX 1: BLOOD BIOCHEMISTRY PARAMETERS",
"APPENDIX 2: HAEMATOLOGY PARAMETERS",
"APPENDIX 3: URINARY ANALYSIS PARAMETERS",
"APPENDIX 4: MDS-UPDRS",
"APPENDIX 5: PROHIBITED CONCOMITANT MEDICATIONS",
"APPENDIX 6: SUBJECT QUESTIONNAIRE",
"MDS-UPDRS Permissions",
"MDS-UPDRS",
"Part I: Non-Motor Aspec... |
NCT03569631 | 1 | SIGNATURES | 1 SIGNATURES | [] |
NCT03569631 | 1.1 | Sponsor Signatures | 1.1 Sponsor Signatures Protocol Number: BPN 14770-CNS-203 Sponsor: Tetra Discovery Partners, lnc. Sponsor Contact: Tetra Discovery Partners, Inc. 38 Fulton Street West, Suite 303 Grand Rapids, MI 4953-2684 Phone: Study Director & Medical Monitor Tetra Discovery Partners, Inc. 38 Fulton Street West, Suite 303 Grand Rapi... | [] |
NCT03569631 | 1.2 | Investigator Signature | 1.2 Investigator Signature I confirm that I have read and that I understand this protocol, the Investigator Brochure, and other product information provided by the Sponsor. I will provide copies of this protocol and access to all information furnished by Tetra Discovery Partners, Inc. to study personnel under my superv... | [
"SYNOPSIS",
"Study Objectives:",
"Exploratory Efficacy Outcome Measures",
"Safety and Tolerability Endpoints",
"Pharmacokinetic Evaluations",
"Study Design",
"Planned Numbers of Subjects",
"Study Duration",
"Study Procedures:",
"Subject Inclusion/Exclusion Criteria:",
"Subject Inclusion Criteria... |
NCT03569631 | 2 | TABLE OF CONTENTS 1 SIGNATURES 2 1.1 Sponsor Signatures 2 1.2 Investigator Signature 3 2 TABLE OF CONTENTS 11 3 LIST OF ABBREVIATIONS 15 4 INTRODUCTION 18 4.1 Background 18 4.2 Rationale 18 4.3 Risk/Benefit 19 4.3.1 Preclinical Pharmacology 19 4.3.2 Clinical Experience 20 4.3.2.1 BPN14770-CNS-101 20 4.3.2.2 BPN14770-CN... | 2 TABLE OF CONTENTS 1 SIGNATURES 2 1.1 Sponsor Signatures 2 1.2 Investigator Signature 3 2 TABLE OF CONTENTS 11 3 LIST OF ABBREVIATIONS 15 4 INTRODUCTION 18 4.1 Background 18 4.2 Rationale 18 4.3 Risk/Benefit 19 4.3.1 Preclinical Pharmacology 19 4.3.2 Clinical Experience 20 4.3.2.1 BPN14770-CNS-101 20 4.3.2.2 BPN14770-... | [] |
NCT03569631 | 3 | LIST OF ABBREVIATIONS | 3 LIST OF ABBREVIATIONS | ABC (-FX) | Aberrant Behavior Checklist (Fragile X specific factoring system) | |-----------|-------------------------------------------------------------------| | | | | ADAMS | Anxiety, Depression, and Mood Scale | | AE(s) | Adverse event(s) | | ADR | Adverse drug reaction | | ALT | Alanine t... | [] |
NCT03569631 | 4 | INTRODUCTION | 4 INTRODUCTION | [] |
NCT03569631 | 4.1 | Background | 4.1 Background Tetra Discovery Partners, Inc. is a central nervous system (CNS) biotechnology company that uses structure-based drug design to discover negative allosteric modulators (NAMs) of phosphodiesterase-4 (PDE4) subtypes for neurological and psychiatric diseases. Tetra has developed a mechanistically novel clas... | [] |
NCT03569631 | 4.2 | Rationale | 4.2 Rationale Fragile X syndrome (FXS) is a disorder in which affected individuals display intellectual disability as well as symptoms typical of autism spectrum disorder, due to silencing of the Xlinked, fragile-X mental retardation-1 (FMR1) gene. Dysregulation of cAMP metabolism is a consistent finding in patients an... | [] |
NCT03569631 | 4.3 | Risk/Benefit | 4.3 Risk/Benefit | [] |
NCT03569631 | 4.3.1 | Preclinical Pharmacology | 4.3.1 Preclinical Pharmacology BPN14770 is a first-in-class, subtype selective, phosphodiesterase type-4D-negative allosteric modulator (PDE4D-NAM). The unique mechanism of action and subtype selectivity distinguishes BPN14770 from the two approved PDE4 inhibitors, roflumilast (Daliresp™) and apremilast (Otezla™). BPN1... | [] |
NCT03569631 | 4.3.2 | Clinical Experience | 4.3.2 Clinical Experience | [] |
NCT03569631 | 4.3.2.1 | BPN14770-CNS-101 | 4.3.2.1 BPN14770-CNS-101 A first-in-human (FIH), single ascending dose (SAD) trial (BPN14770-CNS-101) in 24 healthy subjects at doses ranging from 5 mg to 100 mg has been completed. The results from this study indicate single doses of BPN14770, in the range of 5 mg to 100 mg, were safe and generally well tolerated. The... | [] |
NCT03569631 | 4.3.2.2 | BPN14770-CNS-102 | 4.3.2.2 BPN14770-CNS-102 In the multiple ascending dose (MAD) trial (BPN14770-CNS-102), 76 healthy young and elderly subjects were administered multiple doses of BPN14770 twice daily (every 12 hours) for 8 days. Young subjects (d45 years; n=18 treated, 7 placebo) received twice-daily doses of 15 mg, 30 mg, 50 mg or pla... | [] |
NCT03569631 | 4.3.2.3 | BPN14770-CNS-103 | 4.3.2.3 BPN14770-CNS-103 The third Phase 1 trial of BPN14770 (BPN14770-CNS-103) was a randomized, double-blind, placebo-controlled, 6-period crossover study to evaluate the effects of BPN14770 10 and 50 mg in reversing scopolamine-induced cognitive impairment in healthy volunteers. A positive control, donepezil 10 mg, ... | [] |
NCT03569631 | 4.4 | Study Objectives and Endpoints | 4.4 Study Objectives and Endpoints | [] |
NCT03569631 | 4.4.1 | Study Objectives | 4.4.1 Study Objectives In male Fragile X patients aged 18-45 years, inclusive, receiving standard medications: - x To obtain a preliminary assessment of the efficacy of BPN14770 25 mg bid - x To evaluate the safety and tolerability of BPN14770 25 mg - x To obtain pharmacokinetic, pharmacodynamic, and biomarker data on ... | [] |
NCT03569631 | 4.4.2 | Exploratory Efficacy Outcome Measures | 4.4.2 Exploratory Efficacy Outcome Measures The following instruments will be used to assess the exploratory efficacy endpoints: - x NIH Toolbox Cognitive Battery Modified for Intellectual Disabilities (NIH-TCB) - x Test of Attentional Performance (KiTAP) - x Clinical Global Impression Severity Investigator rated (CGI-... | [] |
NCT03569631 | 4.4.3 | Safety and Tolerability Endpoints | 4.4.3 Safety and Tolerability Endpoints The following safety assessments will be conducted during the study. - x Treatment-emergent Adverse events - x Changes in vital signs - x Clinical laboratory evaluations (chemistry, hematology, urinalysis) - x Changes in electrocardiogram (ECG) measurements \\\\\\\\\\\\\\\\\\\\\\... | [] |
NCT03569631 | 4.4.4 | Pharmacokinetic Endpoints | 4.4.4 Pharmacokinetic Endpoints Plasma BPN14770 concentrations will be measured to verify that study drug is present when expected and to estimate plasma exposure after 12 weeks of treatment. | [] |
NCT03569631 | 4.4.5 | Biomarkers | 4.4.5 Biomarkers Retained plasma samples may be used to explore biomarkers potentially associated with FXS. | [] |
NCT03569631 | 5 | INVESTIGATIONAL PLAN | 5 INVESTIGATIONAL PLAN | [] |
NCT03569631 | 5.1 | Overall Study Design | 5.1 Overall Study Design This is a single center, Phase 2, randomized, double-blind, placebo-controlled, 2-period crossover study to obtain preliminary assessment of the effects of BPN14770 in patients with Fragile X Syndrome. As schematic display of the study design is shown in Figure 1. The study will consist of a Sc... | [] |
NCT03569631 | 5.1.1 | Dose Selection | 5.1.1 Dose Selection The dose of 25 mg BPN14770 to be taken twice daily was chosen for testing in this study. Based on pharmacokinetic data from study BPN14770-CNS-102 (MAD), average plasma concentrations of BPH14770 at 10 mg dosing are projected to be approximately 60 ng/ml. Therefore, the lower dose of 10 mg has the ... | [] |
NCT03569631 | 5.2 | Study Duration | 5.2 Study Duration The total duration of the study for each subject will be up to 29 weeks, including a maximum of a 4-week screening period, two 12-week double-blind Treatment Periods, and a follow-up call approximately 1 week after last treatment. | [] |
NCT03569631 | 6 | SELECTION AND WITHDRAWAL OF SUBJECTS | 6 SELECTION AND WITHDRAWAL OF SUBJECTS | [] |
NCT03569631 | 6.1 | Study Population | 6.1 Study Population Individuals are eligible for the study if they meet all of the inclusion and none of the exclusion criteria. The criteria below will be assessed at the Screening visit which should within 28 days prior to first study drug administration. The Screening and Baseline Visits may be combined if site pro... | [] |
NCT03569631 | 6.2 | Subject Inclusion Criteria | 6.2 Subject Inclusion Criteria 1. Subject is male aged 18 to 45 years, inclusive. BPN14770 Clinical Study Report: BPN14770-CNS-203 \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ Protocol: BPN14770-CNS-203 Tetra Discovery Partners, Inc. Date: 25 June 2018 Confidential 2. Subject has Fragile X Syndrome with a molecul... | [] |
NCT03569631 | 6.3 | Subject Exclusion Criteria | 6.3 Subject Exclusion Criteria The following Exclusions apply to findings during Screening or at Baseline (Day 1): 1. History of, or current cardiovascular, renal, hepatic, respiratory, gastrointestinal, Protocol: BPN14770-CNS-203 Tetra Discovery Partners, Inc. Date: 25 June 2018 Confidential psychiatric, neurologic, c... | [] |
NCT03569631 | 6.4 | Subject Withdrawal | 6.4 Subject Withdrawal All subjects have the right to withdraw from this study at any time. In addition, it is the right of the Investigator to remove subjects from the study as a result of adverse reactions, a protocol violation, or non-compliance, or any other reason. Subjects must be discontinued for the following r... | [] |
NCT03569631 | 6.5 | Replacement of Subjects | 6.5 Replacement of Subjects Subjects who do not meet eligibility criteria at Baseline will not be randomized and will be considered screen failures. Subjects who withdraw from the study for any reason will not be replaced. | [] |
NCT03569631 | 7 | TREATMENT OF SUBJECTS | 7 TREATMENT OF SUBJECTS | [] |
NCT03569631 | 7.1 | Treatment Arms | 7.1 Treatment Arms In this randomized double-blind, placebo-controlled, 2-period cross-over study, 30 patients will be randomized (1:1) to receive each of the following two treatments (one during each 12 week Treatment Period): - x BPN14770 25 mg bid - x Matching Placebo | [] |
NCT03569631 | 7.2 | Study Medications | 7.2 Study Medications The 25 mg BPN14770 capsules and placebo capsules intended for use in this Phase 2 clinical trial are manufactured by Catalent, Inc. and will be packaged, labeled, and shipped for clinical use to sites by Sherpa Clinical Packaging. The 25 mg BPN14770 capsules are manufactured using a wet granulatio... | [] |
NCT03569631 | 7.3 | Drug Accountability | 7.3 Drug Accountability The Investigator or designated study personnel is responsible for keeping accurate records of the study drugs (and other components) used in this study. These records should include documentation of receipt, inventory, and disposition to subject. The records should include dates, quantities, bat... | [] |
NCT03569631 | 7.4 | Blinding | 7.4 Blinding This is a randomized, double-blind study, meaning that neither site staff nor subject will know what the subject is receiving. Randomization codes will be provided to the site pharmacy for use in case of an emergency code break requirement. Confirmation of receipt of the randomization code will be required... | [] |
NCT03569631 | 7.5 | Assignment of Subjects to Treatment Arms | 7.5 Assignment of Subjects to Treatment Arms A randomization schedule will be generated by a statistician unassociated with the study execution prior to the start of the study. Subjects will be randomized on Day 1and receive their first bottle of medication that same day. Protocol: BPN14770-CNS-203 Tetra Discovery Part... | [] |
NCT03569631 | 7.6 | Study Drug Administration | 7.6 Study Drug Administration One capsule is to be taken orally in the morning, and one capsule is to be taken orally at night, with at least 120 mL (4 ounces) of liquid. Doses should be taken at least 6 hours apart, and at least 30 minutes prior to or 1 hour after meals. | [] |
NCT03569631 | 7.7 | Prior and Concomitant Medications | 7.7 Prior and Concomitant Medications A prior medication is defined as any psychotropic or anti-epileptic medication taken by the subject for more than 28 days during the 6 months prior to first dose of study drug (Day 1), which was subsequently discontinued within that same 6 month period. A concomitant medication is ... | [] |
NCT03569631 | 7.8 | Other Therapeutic Treatments | 7.8 Other Therapeutic Treatments Behavioral and therapy treatments/interventions must be stable for 4 weeks prior to Screening and must remain stable during the period between Screening and the commencement of study medication, and throughout the study. | [] |
NCT03569631 | 7.9 | Dietary Guidelines | 7.9 Dietary Guidelines There are no dietary restrictions. Subjects should follow their usual eating behaviors. | [] |
NCT03569631 | 7.10 | Lifestyle Guidelines | 7.10 Lifestyle Guidelines There no lifestyle restrictions or guidelines associated with this study. | [] |
NCT03569631 | 8 | STUDY PROCEDURES AND ASSESSMENTS | 8 STUDY PROCEDURES AND ASSESSMENTS | [] |
NCT03569631 | 8.1 | Informed Consent | 8.1 Informed Consent Informed consent must be obtained prior to the subject entering into the study and before any protocol-directed procedures are performed. Protocol: BPN14770-CNS-203 Tetra Discovery Partners, Inc. Date: 25 June 2018 Confidential | [] |
NCT03569631 | 8.2 | Medical /Surgical History | 8.2 Medical /Surgical History Medical/Surgical history will be recorded at the Screening Visit as specified in Section 10.2. Subject eligibility will be evaluated to determine all inclusion and none of the exclusion criteria are met. The Investigator will inquire with the subject on Period 1/Day 1 (Baseline, prior to r... | [] |
NCT03569631 | 8.3 | Demographics and Social History | 8.3 Demographics and Social History Demographics (sex, ethnicity, race) and social history (tobacco, alcohol, and/or drug use) will be recorded at the Screening Visit as specified in the Schedule of Assessments. | [] |
NCT03569631 | 8.4 | Stanford Binet Intelligence Scale | 8.4 Stanford Binet Intelligence Scale The Stanford Binet Intelligence Scale will be administered at Screening in order to support characterization of the study cohort and to determine whether cognitive and behavioral responses are dependent on baseline level of cognitive functioning. The scale will be scored according ... | [] |
NCT03569631 | 8.5 | Physical Examination (Full and Abbreviated) | 8.5 Physical Examination (Full and Abbreviated) The full physical examination will be conducted at the Screening as specified in the Schedule of Assessments and will include: - x General appearance - x Skin - x Eyes, ears, nose, and throat (EENT) - x Head/neck - x Extremities - x Musculoskeletal examination - x Respira... | [] |
NCT03569631 | 8.6 | Height, Weight, Body Mass Index | 8.6 Height, Weight, Body Mass Index Body weight and height are to be measured at Screening. Body weight will be repeated at the Period 1/Week12 and Period 2/Week 12 visits as specified in the Schedule of Assessments. Subjects will wear indoor clothing and remove their shoes prior to the measurements. Body Mass Index (B... | [] |
NCT03569631 | 8.7 | Vital Signs | 8.7 Vital Signs Vital signs (pulse rate, blood pressure, respiration rate, and temperature) will be measured at Screening and during the Treatment Visits, as specified in the Schedule of Assessments. Blood pressure and heart rate will be measured using a calibrated, fully automated machine with a cuff that is appropria... | [] |
NCT03569631 | 8.8 | Electrocardiograms | 8.8 Electrocardiograms Single 12-lead ECGs will be performed at every clinic visit except the Week 1 visit during each Period as specified in the Schedule of Assessments. ECGs should be obtained after the subject has been resting comfortably in a supine position for approximately 5 minutes. ECGs will be collected prior... | [] |
NCT03569631 | 8.9 | Laboratory Assessments | 8.9 Laboratory Assessments Appendix 16.2 Clinical Laboratory Analytes provides a list of the clinical laboratory tests that will be performed according to the collection schedule provided in the Schedule of Assessments. Blood samples for chemistry and hematology and urine samples will be collected in accordance with ac... | [] |
NCT03569631 | 8.10 | Management of Abnormal Clinical Laboratory Tests | 8.10 Management of Abnormal Clinical Laboratory Tests It is the Investigator's responsibility to review the results of all lab tests as they become available and to document their review by signing and dating the lab report. For each lab test outside of the laboratory normal range, the Investigator must ascertain if th... | [] |
NCT03569631 | 8.11 | Suicidality Assessment | 8.11 Suicidality Assessment Suicidality will be assessed at Screening and at Weeks 1, 2, 6, and 12 of each period. If a concern is detected, it is the responsibility of the Investigator to refer the subject for further evaluation and treatment. A straightforward, caregiver-based assessment tool will be used, as more co... | [] |
NCT03569631 | 8.12 | Additional Safety Measures | 8.12 Additional Safety Measures Subjects and caregivers will be instructed to inform the study physician and/or research personnel of any AEs, including significant behavioral changes not within the typical variation for the subject, that occur at any time during the study. Procedures will be completed as specified in ... | [] |
NCT03569631 | 8.13 | Exploratory Efficacy Assessments | 8.13 Exploratory Efficacy Assessments | [] |
NCT03569631 | 8.13.1 | Descriptions of Efficacy Assessment Instruments | 8.13.1 Descriptions of Efficacy Assessment Instruments Several assessment tools for cognitive and behavioral measures will be utilized in this exploratory study. Raw scores (not standardized) will be collected for all assessments, except for the Vineland -3 composite where age-equivalent scores will also be collected. ... | [] |
NCT03569631 | 8.13.1.1 | NIH-TCB | 8.13.1.1 NIH-TCB The NIH-TCB, a component of the NIH Toolbox for Assessment of Neurological and Behavioral Function, was developed by a team of more than 300 scientists from nearly 100 academic institutions as part of the NIH Blueprint for Neuroscience Research to standardize evaluations in specific clinical population... | [] |
NCT03569631 | 8.13.1.2 | Test of Attentional Performance (KiTAP) | 8.13.1.2 Test of Attentional Performance (KiTAP) The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning.11 Each subtest can be assessed separately. Four subtests will be utilized... | [] |
NCT03569631 | 8.13.1.3 | Clinical Global Impression | 8.13.1.3 Clinical Global Impression The CGI-I (and CGI-S) are gold standard global measures of severity and change with treatment in placebo-controlled pharmacotherapy trials in developmental disabilities and have been used extensively in prior clinical trials in FXS. 14,15 \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\... | [] |
NCT03569631 | 8.13.1.3.1 | Clinical Global Impression Severity: Investigator Rated (CGI-S) | 8.13.1.3.1 Clinical Global Impression Severity: Investigator Rated (CGI-S) 7KH &OLQLFDO \OREDO ,PSUHVVLRQí6HYHULW\ &\,-S) is a global measure to provide a clinical judgment of a subject's overall condition based on a trained clinician's assessment of cognition, behavior and activities of daily living.16 The assessment ... | [] |
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