Phase 3
Completed N=9
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
Infantile Spasms
Source: ClinicalTrials.gov NCT02953548 ↗
Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) — 6 Participants
Summary
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The pilot phase only will be described in this record. 2 cohorts of 5 participants will be enrolled sequentially. All participants will receive GWP42003-P.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) |
6 | — |
| PRIMARY Number of Participants With Any Low or High Hematology Laboratory Parameter Value |
4; 4; 1; 3 | — |
| PRIMARY Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value |
7; 5; 5; 7 | — |
| PRIMARY Number of Participant With Any Clinically Relevant Urinalysis Parameter Value |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Electrocardiogram Findings |
— | — |
| PRIMARY Number of Participants With Clinically Significant Physical Examination Findings |
— | — |
| PRIMARY Number of Participants With Clinically Significant Vital Sign Findings |
— | — |
| SECONDARY Number of Participants Free of Clinical Spasms |
— | — |
| SECONDARY Percentage of Participants Free of Clinical Spasms |
— | — |
| SECONDARY Number of Participants With Resolution of Hypsarrhythmia |
— | — |
| SECONDARY Percentage of Participants With Resolution of Hypsarrhythmia |
— | — |
| SECONDARY Number of Participants Experiencing Spasms and Seizures by Subtype |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Average Time to Cessation of Spasms |
— | — |
| SECONDARY Caregiver Clinical Global Impression of Change (CGIC) |
1; 0; 7; 1; 0; 0 | — |
| SECONDARY Physician Global Impression of Change (PGIC) |
0; 1; 5; 3; 0; 0 | — |
| SECONDARY Number of Responders |
0; 0 | — |
| SECONDARY Percentage of Responders |
0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Participant is aged 6- 24 months (inclusive) in the first cohort or aged 1-24 months (inclusive) in the second cohort, at the time of consent.
- Participant is diagnosed with IS and has failed to respond adequately following treatment with 1 or more approved IS therapies.
- To be considered hypsarrhythmia, as defined for use in the study, the electroencephalography (EEG) background must be slowed and have multifocal spikes. In addition, it must be either high voltage (above 300 µV) or have electrodecrement/discontinuity.
Key Exclusion Criteria
- Participant is currently taking or has taken clobazam or any mammalian target of rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.
- Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), of 460 msec or greater on ECG.
- Participant's caregiver is currently giving or has given recreational or medicinal cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the screening visit.
- Participant's caregiver is unwilling to abstain from giving the participant (including the participant's mother abstaining themselves, if breastfeeding)recreational or medicinal cannabis, or synthetic cannabinoid-based medications (other than the study drug) during the trial.
- Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug, such as sesame oil.
- Participant has significantly impaired hepatic function at the screening visit.
- Participant has received an investigational medicinal product as part of a clinical trial within a minimum of 5 half-lives prior to the screening visit.
Data sourced from ClinicalTrials.gov (NCT02953548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.