protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04620135 | 10.3 | Ethical Conduct of the Study | 10.3 Ethical Conduct of the Study The study will be conducted according to ethical principles based on the Declaration of Helsinki and the guidance stipulated in Article 14, Paragraph 3, and Article 80 2 of the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan, Ministry of Health, Labor and W... | [] |
NCT04620135 | 10.4 | Subject Information and Consent | 10.4 Subject Information and Consent Informed consent must take place before any study specific procedures are initiated. Signed and dated written informed consent must be obtained from each subject and/or from the subject's legal guardian prior to enrollment into the study in accordance with local regulatory requireme... | [] |
NCT04620135 | 10.5 | Subject Confidentiality | 10.5 Subject Confidentiality The Investigator and his/her staff will maintain all personal subject data collected and processed for the purposes of this study using adequate precautions to ensure confidentiality, in accordance with local regulations. Monitors, auditors and other authorized representatives of Aerie, the... | [] |
NCT04620135 | 10.6 | Study Monitoring | 10.6 Study Monitoring Clinical research associates hired or contracted by the Sponsor will be responsible for monitoring the study sites and study activities. They will contact and visit the Investigator regularly. The actual frequency of monitoring visits depends on subject enrollment and on study site performance. Am... | [] |
NCT04620135 | 10.7 | Case Report Forms and Study Records | 10.7 Case Report Forms and Study Records Study data will be recorded via electronic CRFs. Each authorized study staff member will receive a unique access account in order to use the Electronic Data Capture (EDC) system. Access accounts will not be shared among study staff. Authorized users will make entries and/or chan... | [] |
NCT04620135 | 10.8 | Protocol Deviations | 10.8 Protocol Deviations A protocol deviation occurs when there is non-adherence to study procedures or schedules. Examples of deviations include common out of window visits or timed procedures, a missed procedure, etc. Sites will record protocol deviations in the study records. To the extent possible, sites will make ... | [] |
NCT04620135 | 10.9 | Access to Source Documentation | 10.9 Access to Source Documentation Monitors, auditors, and other authorized representatives of the Sponsor, the governing IRB(s), and local regulatory agencies will be granted direct access to the study subject's original medical and study records for verification of the data and/or clinical study procedures. Access t... | [] |
NCT04620135 | 10.10 | Data Generation and Analysis | 10.10 Data Generation and Analysis After data have been entered into the study EDC system database, a system of computerized data validation checks will be implemented and applied to the database. Query reports pertaining to data omissions and discrepancies will be forwarded to the clinical Investigator and the Sponsor... | [] |
NCT04620135 | 10.11 | Retention of Data | 10.11 Retention of Data All study related correspondence, patient records, consent forms, patient privacy documentation, records of distribution and use of all study drugs, and copies of eCRFs should be maintained on file. In Japan, the records should be retained until the day on which marketing approval of the test dr... | [] |
NCT04620135 | 10.12 | Financial Disclosure | 10.12 Financial Disclosure The Principal Investigator and sub-Investigators will provide financial disclosure information prior to participation in the study. The Principal Investigator and any sub-Investigators will notify the Sponsor promptly of any required revision to their financial disclosure status during the te... | [] |
NCT04620135 | 10.13 | Publication and Disclosure Policy | 10.13 Publication and Disclosure Policy Aerie Pharmaceuticals, as the Sponsor, has proprietary interest in the study. Authorship and manuscript composition will reflect joint cooperation between multiple investigators and sites and Aerie Pharmaceuticals personnel and will be administrated by a steering committee. As th... | [] |
NCT04620135 | 11 | REFERENCES | 11. REFERENCES | [] |
NCT04620135 | 11.1 | External References | 11.1 External References - 1. The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol 2000; 130:429-40. - 2. Chen J, Runyan SA, Robinson MR. Novel ocular antihypertensive compounds in clinical tr... | [] |
NCT04620135 | 11.2 | Internal References | 11.2 Internal References  Confidential Page 64 of 80 
Appendix 1 Schedule of Visits and Procedures | | | | | | | 1PoDa1Trttmtsyeaen | | | | | | | | | |---------------------------------------------------------------------------------------------------------------|---------... | [
"Appendix 1 Schedule of Visits and Procedures",
"Appendix 1 Schedule of Visits and Procedures (cont'd)",
"Appendix 2 Sponsor's Obligations",
"Appendix 3 Investigator's Obligations"
] |
NCT04620135 | 13 | Maintenance of records: | 13. Maintenance of records: - a) Disposition of drug. An Investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the Investigator shall return the unused supplies of t... | [
"Appendix 4 Declaration of Helsinki",
"I. BASIC PRINCIPLES",
"II. MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE (CLINICAL RESEARCH)",
"III. NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECT (NONCLINICAL BIOMEDICAL RESEARCH)",
"Appendix 5 Study Monitoring",
"Appendix 7 Protocol Amendment",
"... |
NCT04625101 | 2 | SYNOPSIS | 2. SYNOPSIS  The starting dose of study treatment for the sentinel cohort (dose level 1) will be based on body weight categories (based on subjects' body weight on Day 1), as detailed in the table below. Based on the exposure data obtained from the sentinel cohort, the doses may be adjusted if req... | [
"Safety:",
"LIST OF TABLES"
] |
NCT04625101 | 3 | LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS | 3. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS AE adverse event ASM antiseizure medication ANCOVA analysis of covariance ALT alanine aminotransferase AST aspartate aminotransferase β-hCG beta-human chorionic gonadotropin CFR Code of Federal Regulations CGI-C Clinical Global Impression of Change CGI-S Clinical Global... | [] |
NCT04625101 | 4 | ETHICS | 4. ETHICS The sponsor personnel and the investigators will ensure that the study is conducted in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines and with the laws and regulations of the country in whic... | [] |
NCT04625101 | 5 | INTRODUCTION | 5. INTRODUCTION | [] |
NCT04625101 | 5.1 | Background | 5.1. Background Calcium is an important signal transduction element in neurons and its entry into the cell is tightly regulated by two major classes of voltage-gated calcium channels: the high-voltage activated (L-, N-, P/Q- and R-types) and the low-voltage activated (T-type) calcium channels [\(Catterall et al., 2005\... | [] |
NCT04625101 | 5.2 | NBI-827104 | 5.2. NBI-827104 NBI-827104 is a novel selective and orally available triple T-type calcium channel blocker. NBI-827104 effectively crosses the blood-brain barrier and shows dose-dependent efficacy in 3 rodent models of generalized epilepsy, including synergistic effects when combined with established antiseizure medica... | [] |
NCT04625101 | 5.3 | Study and Dose Rationale | 5.3. Study and Dose Rationale  Based on a population pharmacokinetic (PK) model, weight-based dose regimens were developed across weight categories to determine the actual daily mg doses to be administered based on individual subject body weight. The maximum exposure level for all subjects will ... | [] |
NCT04625101 | 5.4 | Benefit-Risk Assessment | 5.4. Benefit-Risk Assessment EECSWS is a spectrum of epileptic conditions [\(International League Against Epilepsy, 2018\)](#page-69-0) with onset in early childhood and include sleep potentiation of epileptiform activity. The potentiation of epileptiform activity during sleep leads to an electroencephalogram (EEG) pat... | [] |
NCT04625101 | 6 | STUDY OBJECTIVES | 6. STUDY OBJECTIVES
Primary Objective: • To assess the effect of NBI-827104 on the overnight epileptiform video-electroencephalogram (video-EEG) activity in pediatric subjects with EECSWS
Secondary Objective: • To evaluate the safety and tolerability of multiple doses of NBI-827104 in pediatric subjects with EECSWS
... | [
"Primary Objective:",
"Secondary Objective:",
"Other Objectives:"
] |
NCT04625101 | 7 | STUDY DESIGN | 7. STUDY DESIGN This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study designed to assess the efficacy, safety, tolerability, and PK of NBI-827104 in pediatric subjects with EECSWS. Approximately 24 male and female subjects, aged 4 to 12 years (inclusive), will be enrolled for study part... | [] |
NCT04625101 | 8 | STUDY POPULATION | 8. STUDY POPULATION | [] |
NCT04625101 | 8.1 | Inclusion Criteria | 8.1. Inclusion Criteria To participate in this study, subjects must meet the following criteria: - 1. Signed informed consent by the parent(s) or legal representative(s) and, if applicable, assent from developmentally capable pediatric subjects. Consent/assent may be done remotely, if allowed per the site's institution... | [] |
NCT04625101 | 8.2 | Exclusion Criteria | 8.2. Exclusion Criteria Subjects will be excluded from the study if they: - 1. Are females who are pregnant or currently breastfeeding. - 2. Lennox-Gastaut syndrome, Doose syndrome (epilepsy with myoclonic-atonic seizures), or Dravet syndrome. - 3. Have a history of neurodegenerative disorders. - 4. Presence of a relev... | [] |
NCT04625101 | 8.3 | Subject Identification and Replacement of Subjects | 8.3. Subject Identification and Replacement of Subjects Subjects will be identified by their unique Subject identification (ID) number. The subject ID will be noted on electronic case report forms (eCRFs), all source documentation, laboratory documents, and ECG tracings. Subjects who discontinue from the study will not... | [] |
NCT04625101 | 8.4 | Randomization | 8.4. Randomization On Day 1, eligible subjects will return to the study center for collection of baseline safety and efficacy assessments. Subjects who continue to be eligible for the study will then be randomized to NBI-827104 or placebo. The first 6 subjects (randomized 2:1; ie, 4 subjects randomized to NBI-827104 an... | [] |
NCT04625101 | 9 | STUDY EVALUATIONS | 9. STUDY EVALUATIONS | [] |
NCT04625101 | 9.1 | Schedule of Assessments | 9.1. Schedule of Assessments A schedule of assessments is shown in [Table 2.](#page-28-1) All study visits after Day 1 will have a visit window of ±3 days. Visits will be the beginning of the week for and the end of the week for . Informed consent by the parent(s) or legal representative(s) and, if applicable, pediatri... | [] |
NCT04625101 | 9.2 | Efficacy Assessments | 9.2. Efficacy Assessments | [] |
NCT04625101 | 9.2.1 | Overnight Video-Electroencephalogram | 9.2.1. Overnight Video-Electroencephalogram  Detailed information on the conduct and analysis of the video-EEG will be provided in the EEG Charter.  | [] |
NCT04625101 | 9.2.4 | Clinical Global Impression of Change | 9.2.4. Clinical Global Impression of Change The Clinical Global Impression of Change (CGI-C), which is based on a 7-point scale (range: 1=very much improved to 7=very much worse), will be used to rate the overall global improvement since the initiation of study treatment dosing. This scale is a modification of a scale ... | [] |
NCT04625101 | 9.2.5 | Caregiver Global Impression of Change | 9.2.5. Caregiver Global Impression of Change The Caregiver Global Impression of Change (Caregiver GI-C), which is based on a 7-point scale (range: 1=very much improved to 7=very much worse), will be used to rate the overall global condition since the initiation of study treatment dosing. This scale is a modification of... | [] |
NCT04625101 | 9.2.6 | Clinical Global Impression of Severity | 9.2.6. Clinical Global Impression of Severity The Clinical Global Impression of Severity (CGI-S) scale will be used to assess overall severity on a 7-point scale (range: 1=normal, not at all ill to 7=among the most extremely ill patients).     9.7.1 and [Section](#page-53-1) 11, respectively. Additional safety assessments are described in the following sections. For any abnormal safety assessment deemed clinically significan... | [] |
NCT04625101 | 9.4.1 | Independent Data Monitoring Committee | 9.4.1. Independent Data Monitoring Committee Ongoing review of safety and tolerability data and the unblinded analysis of sentinel cohort data (including safety, tolerability, and PK data [PK data will only be assessed at will be conducted by the IDMC. The IDMC has the overall responsibility of safeguarding the interes... | [] |
NCT04625101 | 9.4.2 | Vital Sign Measurements | 9.4.2. Vital Sign Measurements Vital sign measurements, including SBP and DBP, pulse rate, and body temperature will be measured. Orthostatic blood pressures may be considered optional if the subject is unable to stand (eg, subject is in a wheelchair). If the investigator is unable to obtain orthostatic blood pressures... | [] |
NCT04625101 | 9.4.3 | Medical History | 9.4.3. Medical History A medical history will be taken at the screening visit and updated on Day 1 and as needed throughout the study. | [] |
NCT04625101 | 9.4.4 | Physical and Neurological Examination Including Height/Length and Weight | 9.4.4. Physical and Neurological Examination Including Height/Length and Weight The complete physical and neurological examination will consist of an assessment of general appearance, skin and mucosae, head, eyes, ears, nose, throat, neck (including thyroid), lymph nodes, chest/lungs, cardiovascular, abdomen, extremiti... | [] |
NCT04625101 | 9.4.5 | Electrocardiogram | 9.4.5. Electrocardiogram A standard 12-lead ECG will be recorded in triplicate (at least 1 minute apart and within 15 minutes) after the subject has rested supine for at least 5 minutes. The ECG will be centrally read and the parameters that will be assessed include pulse, PR interval, QRS duration, QT interval, and QT... | [] |
NCT04625101 | 9.4.6 | Clinical Laboratory Assessments | 9.4.6. Clinical Laboratory Assessments All clinical laboratory assessments will be performed by a central laboratory. In addition, a urine pregnancy test will be performed by the study site on Day 1 to confirm subject eligibility. The central laboratory will provide instructions and supplies to the study staff before s... | [] |
NCT04625101 | 9.4.7 | Estimated Total Blood Sample Volume | 9.4.7. Estimated Total Blood Sample Volume The estimated total blood sample volume for each subject is presented in Table 3. These estimates include samples to be collected during screening, the treatment periods, and the final visit (or upon early termination).  | [] |
NCT04625101 | 9.4.8 | Columbia-Suicide Severity Rating Scale Children's Versions | 9.4.8. Columbia-Suicide Severity Rating Scale Children's Versions The C-SSRS is a validated instrument to prospectively assess suicidal ideation and behavior (http://www.cssrs.columbia.edu). There are versions of the questionnaire designed for use at screening (Children's Baseline version) and at baseline and visits th... | [] |
NCT04625101 | 9.4.9 | Ophthalmic Examination | 9.4.9. Ophthalmic Examination An age-appropriate ophthalmic examination will be performed consisting of visual acuity, pupillary light reflex, retinoscopy, as well as slit lamp microscopy testing (following pupillary dilation, and if cooperation can be achieved). Clinically relevant findings occurring after informed co... | [] |
NCT04625101 | 9.5 | Specific Study Period Information | 9.5. Specific Study Period Information Study visits during the maintenance period may be conducted remotely if individual in-person study visits at the study site are not possible due to Corona Virus Disease 2019 (COVID 19) related reasons (eg, subject is not able to travel to the site for safety reasons or as part of ... | [] |
NCT04625101 | 9.5.1 | Screening (Days -28 to -1) | 9.5.1. Screening (Days -28 to -1) After signed informed consent by the parent(s) or legal representative(s) and, if applicable, pediatric assent from developmentally capable pediatric subjects is/are obtained, subjects will undergo screening procedures between Day -28 and Day -1. During screening, the following study e... | [] |
NCT04625101 | 9.5.1.1 | Diagnosis Confirmation Panel | 9.5.1.1. Diagnosis Confirmation Panel An external DCP will review and confirm that the subject meets the clinical diagnosis of EECSWS to determine study eligibility prior to randomization on Day 1. Medical history information, as well as any further medical information supporting the diagnosis if available (including t... | [] |
NCT04625101 | 9.5.2 | Titration Period | 9.5.2. Titration Period | [] |
NCT04625101 | 9.5.2 | 1. | 9.5.2.1.   9.5.2.2.  | [] |
NCT04625101 | 9.5.3 | Maintenance Period | 9.5.3. Maintenance Period 9.5.3.1.  9.5.3.2.    | [] |
NCT04625101 | 9.6 | Study Duration | 9.6. Study Duration | The expected duration of study participation for subjects who do not enroll directly into an OLE | | | | | |--------------------------------------------------------------------------------------------------|---------------------|---------------------|-----------------------------------------------... | [] |
NCT04625101 | 9.7 | Prohibitions and Restrictions | 9.7. Prohibitions and Restrictions | [] |
NCT04625101 | 9.7.1 | Prior and Concomitant Medications | 9.7.1. Prior and Concomitant Medications All prescription and over-the-counter medications, dietary supplements (including vitamins), and herbal supplements taken by the subject within 30 days before screening will be recorded on the Prior and Concomitant Medications page of the eCRF. The following medications are allo... | [] |
NCT04625101 | 9.7.2 | Dietary Restrictions | 9.7.2. Dietary Restrictions | [] |
NCT04625101 | 9.7.3 | Other Restrictions | 9.7.3. Other Restrictions Subjects will be confined to the study center for 3 overnight stays (screening, visit [approximately 24 hours], and visit). Subjects will be discharged from the study center after completion of study assessments in the morning after overnight stays. Participation in another investigational dru... | [] |
NCT04625101 | 9.8 | Discontinuation of Study Treatment and Subject Withdrawal | 9.8. Discontinuation of Study Treatment and Subject Withdrawal Subjects/caregivers can discontinue study treatment or withdraw their consent to participate in the study at any time. The investigator must discontinue study treatment dosing or withdraw any subject from the study if a subject/caregiver requests study trea... | [] |
NCT04625101 | 9.8.1 | Discontinuation of Study Treatment Dosing | 9.8.1. Discontinuation of Study Treatment Dosing If a subject prematurely discontinues study treatment dosing, the investigator will record the reason for discontinuation on the relevant eCRF. Such subjects will not be automatically withdrawn from the study and should continue participation in the study. The investigat... | [
"• Protocol deviation"
] |
NCT04625101 | 9.8.2 | Withdrawal from Study | 9.8.2. Withdrawal from Study If a subject prematurely withdraws from the study, the investigator will record the reason for withdrawal on the relevant eCRF. All subjects who withdraw from the study prematurely will be asked to have all early termination assessments performed. Reasons for withdrawal from study include, ... | [] |
NCT04625101 | 9.8.3 | Sponsor's Termination or Pause of Study | 9.8.3. Sponsor's Termination or Pause of Study The Sponsor reserves the right to discontinue or pause the study overall or at the level of individual sites at any time for clinical or administrative reasons. Study termination must be implemented by the investigator, if instructed to do so by the Sponsor in a time frame... | [] |
NCT04625101 | 10 | STUDY TREATMENT | 10. STUDY TREATMENT | [] |
NCT04625101 | 10.1 | Study Treatment Supplies | 10.1. Study Treatment Supplies | [] |
NCT04625101 | 10.1.1 | NBI-827104 | 10.1.1. NBI-827104 The Sponsor or its designee will provide the study center with a supply of NBI-827104 minitablets sufficient for the completion of the treatment period of the study. | [] |
NCT04625101 | 10.1.2 | Placebo/Reference Drug | 10.1.2. Placebo/Reference Drug The Study Sponsor or its designee will provide the study center with a supply of matching placebo minitablets sufficient for the completion of the treatment period of the study. | [] |
NCT04625101 | 10.2 | Study Treatment Storage | 10.2. Study Treatment Storage Formulated NBI-827104 and placebo minitablets The investigator should refer to the label of the study treatment for information on the storage conditions. Study treatment should be stored and inventoried according to applicable local and federal regulations and study procedures. | [] |
NCT04625101 | 10.3 | Study Treatment Packaging and Labeling | 10.3. Study Treatment Packaging and Labeling Each bottle of NBI-827104 or matching placebo will be supplied with a minitablet dispensing device. Instructions on use of the device for dosing will be provided in the Pharmacy Manual. Study treatment will be labeled to comply with the applicable laws and regulations of the... | [] |
NCT04625101 | 10.4 | Direct-to-Subject Shipments of Study Treatment | 10.4. Direct-to-Subject Shipments of Study Treatment To ensure continued access to study treatment, if a subject is unable to go to the site when study treatment is to be dispensed, study treatment may be delivered from the site's pharmacy to the subject's residence by a distributor independent from the Sponsor. The su... | [] |
NCT04625101 | 10.5 | Blinding | 10.5. Blinding This study includes up to of double-blind, placebo-controlled treatment during which the subject, investigator, and all study center personnel will be blinded to the subject's treatment. The Sponsor will be blinded except for supply chain personnel who are not involved in decisions regarding subject trea... | [] |
NCT04625101 | 10.6 | Study Treatment Preparation and Administration | 10.6. Study Treatment Preparation and Administration  | [] |
NCT04625101 | 10.7 | Study Treatment Compliance and Accountability | 10.7. Study Treatment Compliance and Accountability Subjects/caregivers will bring all unused study treatment and empty drug packaging material to the center at specified study visits for drug accountability and reconciliation by study center personnel. A compliance check will be performed by weighing the container wit... | [] |
NCT04625101 | 10.8 | Study Treatment Return | 10.8. Study Treatment Return Returns will be shipped to NBI or its designee at the completion of the study according to instructions provided by NBI or its designee according to applicable state and federal regulations and study procedures. | [] |
NCT04625101 | 11 | ADVERSE EVENTS | 11. ADVERSE EVENTS All AEs, whether observed by the investigator, reported by the subject, noted from laboratory findings, or identified by other means, will be recorded from the time the ICF has been signed until the subject's final study visit (or upon early termination). | [] |
NCT04625101 | 11.1 | Definition | 11.1. Definition An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laborato... | [] |
NCT04625101 | 11.1.1 | Intensity of Adverse Events | 11.1.1. Intensity of Adverse Events AEs must be graded for intensity. An intensity category of mild, moderate, or severe, as defined in Table 4, must be entered on the AE eCRF. It should be noted that the term "severe" used to grade intensity is not synonymous with the term "serious." Table 4: Intensity of Adverse Even... | [] |
NCT04625101 | 11.1.2 | Relationship to Study treatment | 11.1.2. Relationship to Study treatment The investigator will document his/her opinion of the relationship of the AE to treatment with study treatment using the criteria outlined in [Table 5.](#page-55-2) An AE is deemed associated with the use of the study treatment "if there is a reasonable possibility that the drug ... | [] |
NCT04625101 | 11.2 | Recording Adverse Events | 11.2. Recording Adverse Events For randomized subjects, each AE will be listed as a separate entry on an AE eCRF. Screen failure subjects will have AE information noted only in the source document. The investigator (or designee) will provide information on dates of onset and resolution, intensity, seriousness, frequenc... | [] |
NCT04625101 | 11.3 | Poststudy Follow-Up of Adverse Events | 11.3. Poststudy Follow-Up of Adverse Events All AEs, including clinically significant changes in ECGs, physical and neurological examination findings, or isolated clinically significant laboratory findings must be followed until the event resolves, the condition stabilizes, the event is otherwise explained, or the subj... | [] |
NCT04625101 | 11.4 | Serious Adverse Events | 11.4. Serious Adverse Events All SAEs will be recorded from the time the ICF has been signed until the final study visit. Investigators are not obligated to actively seek SAEs after a subject has withdrawn from or completed the study. However, if the investigator learns of any SAE, including a death, at any time after ... | [] |
NCT04625101 | 11.4.1 | Definition of a Serious Adverse Event | 11.4.1. Definition of a Serious Adverse Event An SAE is any AE that results in any of the following outcome: - Death. - A life-threatening AE. Life-threatening means that the subject was, in the view of the investigator or Sponsor, at immediate risk of death from the reaction as it occurred. It does not mean that hypot... | [] |
NCT04625101 | 11.4.2 | Managing Serious Adverse Events | 11.4.2. Managing Serious Adverse Events Subjects experiencing an SAE or an emergency situation will be examined by a physician as soon as possible. The physician in attendance will do whatever is medically needed for the safety and well-being of the subject. The subject will remain under observation as long as medicall... | [] |
NCT04625101 | 11.4.3 | Reporting Serious Adverse Events and Other Immediately Reportable Events | 11.4.3. Reporting Serious Adverse Events and Other Immediately Reportable Events SAEs and other immediately reportable events (defined in [Section](#page-55-0) 11.2) must be reported within 24 hours of first knowledge of the event by study personnel to the Sponsor (contact information provided on the respective forms).... | [] |
NCT04625101 | 11.4.4 | Expedited Safety Reports | 11.4.4. Expedited Safety Reports The Sponsor or its representatives will submit an Expedited Safety Report for any suspected adverse reaction (as defined in [Section](#page-54-1) 11.1.2) that is considered both serious and unexpected within 15 calendar days and for any unexpected fatal or life-threatening experience wi... | [] |
NCT04625101 | 11.5 | Pregnancy | 11.5. Pregnancy Pregnancy is neither an AE nor an SAE unless the criteria for an SAE are met. However, all pregnancies in female subjects who received NBI-827104 will be followed to assess for congenital anomaly. Subjects of childbearing potential must be counseled at all visits to continue using birth control (see [in... | [] |
NCT04625101 | 12 | DOCUMENTATION OF DATA | 12. DOCUMENTATION OF DATA | [] |
NCT04625101 | 12.1 | Case Report Forms | 12.1. Case Report Forms The eCRF data for this study are being collected with an electronic data capture (EDC) system. The EDC system and the study-specific eCRFs will comply with Title 21 CFR Part 11. The documentation related to the validation of the EDC system is available through the EDC vendor, while the validatio... | [] |
NCT04625101 | 12.2 | Data Capture, Review, and Validation | 12.2. Data Capture, Review, and Validation Data entered in the EDC system will be verified against the source data by the Sponsor (or designee). Any discrepancies will be corrected online by authorized study center personnel. Automated (computer-generated) logic checks will run in order to identify items such as incons... | [] |
NCT04625101 | 12.3 | Coding Dictionaries | 12.3. Coding Dictionaries AEs and medical history will be coded using the chosen version of the Medical Dictionary for Regulatory Activities (MedDRA). Prior and concomitant medications will be coded using the chosen version of the World Health Organization Drug Dictionary (WHO Drug). | [] |
NCT04625101 | 13 | STATISTICAL AND ANALYTICAL PLAN | 13. STATISTICAL AND ANALYTICAL PLAN | [] |
NCT04625101 | 13.1 | Overview | 13.1. Overview The analysis plan provided in this protocol represents a brief description of the planned analyses. The comprehensive statistical analysis plan (SAP) will be generated prior to final study database lock. The SAP may include a number of additional analyses and data summaries not described in this protocol... | [] |
NCT04625101 | 13.2 | Analysis Sets | 13.2. Analysis Sets Four analysis sets are defined: • Full Analysis Set (FAS) This analysis set includes all randomized subjects who took at least one dose of study treatment and have at least one efficacy video-EEG assessment. Subjects will be analyzed according to their randomized treatment group. .
• Per-protocol s... | [
"• Per-protocol set",
"• Safety set",
"• Pharmacokinetic set"
] |
NCT04625101 | 13.3 | Sample Size Determination | 13.3. Sample Size Determination The sample size is based on the primary endpoint, expressed as a ratio of SWI at the end of to baseline. A ratio to baseline was preferred over an absolute or relative change from baseline, because of the better statistical properties of the former. The associated summary statistic on a ... | [] |
NCT04625101 | 13.4 | Handling of Missing Data | 13.4. Handling of Missing Data All available study data will be included in relevant summaries and data displays, including any available data for subjects with incomplete or missing data. Missing data for the primary efficacy endpoint (ratio of SWI at the end of to baseline) will be imputed using last observation carr... | [] |
NCT04625101 | 13.5 | Disposition of Subjects | 13.5. Disposition of Subjects A summary of subject disposition will be prepared that displays the number of subjects who were randomized, received study treatment, and completed the study. The number of subjects who did not complete the study will be displayed both overall and by reason for discontinuation. | [] |
NCT04625101 | 13.6 | Important Protocol Deviations | 13.6. Important Protocol Deviations A summary of the number and percentage of subjects with important protocol deviations by deviation category and by treatment group will be provided for all randomized subjects. | [] |
NCT04625101 | 13.7 | Demographics and Baseline Subject Characteristics | 13.7. Demographics and Baseline Subject Characteristics Age, height/length, weight, body mass index, gender, race, and ethnicity will be summarized with descriptive statistics or frequency tables as appropriate. | [] |
NCT04625101 | 13.8 | Study Treatment Dosing and Compliance | 13.8. Study Treatment Dosing and Compliance The average daily dose of study treatment will be summarized using descriptive statistics over the periods corresponding to each dose level (ie, ) for each body weight category. The cumulative dose of study treatment taken over the entire study period will also be summarized.... | [] |
NCT04625101 | 13.9 | Pharmacokinetic Parameters | 13.9. Pharmacokinetic Parameters PK analyses will be performed using the pharmacokinetic analysis set. PK parameters will be calculated using non-compartmental methods.  | [] |
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