Trial · NCT02954887
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) | From signing of informed consent up to Day 417 | TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP. |
| Primary | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | |
| Primary | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | |
| Primary | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | Clinical relevance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Electrocardiogram Findings | From signing of informed consent up to Day 389 | Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Vital Sign Findings | From signing of informed consent up to Day 389 | Clinical significance was determined by the investigator. |
| Primary | Number of Participants With Clinically Significant Physical Examination Findings | From signing of informed consent up to Day 389 | Clinical significance was determined by the investigator. |
| Secondary | Number of Participants Free of Clinical Spasms | Days 29, 43, 127, 211, 295, and 379 | Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours. |
| Secondary | Percentage of Participants Free of Clinical Spasms | Days 29, 43, 127, 211, 295, and 379 | Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Number of Participants With a Resolution of Hypsarrhythmia | Days 29, 43, 127, 211, 295, and 379 | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Percentage of Participants With a Resolution of Hypsarrhythmia | Days 29, 43, 127, 211, 295, and 379 | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Number of Participants Experiencing Spasms and Seizures by Subtype | Days 19, 29, 127, 211, 295, and 379 | Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizure included, clonic, tonic-clonic, myoclonic, focal, and absence. |
| Secondary | Caregiver Global Impression of Change (CGIC) | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 | The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. |
| Secondary | Physician Global Impression of Change (PGIC) | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 | The PGIC is a single-question assessment completed by the investigator. The question assessed the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. |
| Secondary | Number of Responders | Days 29, 43, 127, 211, 295, and 379 | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Percentage of Responders | Days 29, 43, 127, 211, 295, and 379 | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. |
| Secondary | Change From Baseline in Height | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 | A positive change indicates an increase in the average participant's height. A negative change indicates a decrease in the average participant's height. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in Body Weight. | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 | A positive change indicates an increase in the average participant's weight. A negative change indicates a decrease in the average participant's weight. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in Head Circumference | Baseline (Day 1 of PIlot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 | A positive change indicates an increase in the average participant's head circumference. A negative change indicates a decrease in the average participant's head circumference. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score | Baseline (Day 1 of Pilot Study); Day 211, Day 379 | The Vineland-II scores were assessed by the participant's caregiver. Caregivers were asked to score questions in the following categories: the participant's communication, daily living, physical activity, problem behaviors, and social skills and relationships. Scoring was slightly different for each section, but generally ranged from "usually" (2) to "never" (0). The total score is calculated as the sum of standard scores from the domains and converted into the adaptive behavior composite score (ranging from 20 to 160). Higher scores represent greater levels of functioning, and lower scores represent lower levels of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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