Trial · NCT04485104
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 Treatment-Emergent Adverse Events (TEAEs) | From start of treatment to the post-treatment safety follow-up visit, up to 62 weeks | |
| Primary | Mean Change From Baseline in Blood Pressure | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Pulse Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Respiratory Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Body Temperature | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Height | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Body Weight | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in Heart Rate | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in RR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in PR Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in QRS Duration | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in QT Interval | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Mean Change From Baseline in QTcB and QTcF | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Number of Participants With a Clinically Significant Change in Laboratory Parameters | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Number of Participants With Emergence of New Types of Seizures | From baseline up to the end of taper follow-up visit (Visit 20), up to 62 weeks | |
| Primary | Plasma Concentrations of GWP42003-P and Its Major Metabolites | Predose, 3 hours and 6 hours post dose at End of Treatment (Week 52) | |
| Primary | Number of Participants Based on Percentage Change From Baseline in Indication-Specific Total Countable Seizures as Recorded by Caregivers | Day 1 up to Taper Period, up to Week 52 | |
| Primary | Clinician Global Impression of Severity (CGI/S) Score | At Day 365 (EOT) | The CGIC/S is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported. The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome. |
| Primary | Clinician Global Impression of Change (CGI/C) Score | At Day 365 (EOT) | The CGI/C is a comprehensive neurodevelopmental assessment that covers the following domains: sensory, motor, cognition, emotional/behavioral health, communication, social, and adaptive functioning. This assessment is a 2-question survey per domain to be completed by the clinician. Individual domain scores are reported. The severity of impairment in each domain is rated by the clinician in a scale of 1 through 7 where 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Higher scores indicate poor clinical outcome. |
| Secondary | Number of Treatment Responders | Day 1 up to the taper period, up to Week 52 | Treatment Responders are defined as participants with ≥ 50% reduction from baseline in caregiver-reported total countable seizures |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04485104/registered