Phase 3
Completed N=9
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
Infantile Spasms
Source: ClinicalTrials.gov NCT02954887 ↗
Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) — 7 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) |
7 | — |
| PRIMARY Number of Participants With Any Low or High Hematology Laboratory Parameter Value |
3; 4; 3; 4; 1; 2 | — |
| PRIMARY Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value |
6; 7; 6; 6; 4; 5 | — |
| PRIMARY Number of Participants With Any Clinically Relevant Urinalysis Parameter Value |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Electrocardiogram Findings |
— | — |
| PRIMARY Number of Participants With Clinically Significant Vital Sign Findings |
— | — |
| PRIMARY Number of Participants With Clinically Significant Physical Examination Findings |
— | — |
| SECONDARY Number of Participants Free of Clinical Spasms |
1; 2; 1; 1; 1; 3 | — |
| SECONDARY Percentage of Participants Free of Clinical Spasms |
11.1; 22.2; 11.1; 11.1; 11.1; 33.3 | — |
| SECONDARY Number of Participants With a Resolution of Hypsarrhythmia |
1; 0; 1; 0; 1; 3 | — |
| SECONDARY Percentage of Participants With a Resolution of Hypsarrhythmia |
11.1; 0; 11.1; 0; 11.1; 33.3 | — |
| SECONDARY Number of Participants Experiencing Spasms and Seizures by Subtype |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Caregiver Global Impression of Change (CGIC) |
1; 1; 5; 1; 0; 0 | — |
| SECONDARY Physician Global Impression of Change (PGIC) |
1; 1; 2; 4; 0; 0 | — |
| SECONDARY Number of Responders |
1; 0; 0; 0; 1; 3 | — |
| SECONDARY Percentage of Responders |
11.1; 0; 0; 0; 11.1; 33.3 | — |
| SECONDARY Change From Baseline in Height |
75.04; 0.85; 0.92; 3.10; 3.38; 5.33 | — |
| SECONDARY Change From Baseline in Body Weight. |
9.92; 0.39; 0.75; 1.10; 1.25; 1.17 | — |
| SECONDARY Change From Baseline in Head Circumference |
44.71; -0.01; 0.54; 0.70; 1.50; 0.75 | — |
| SECONDARY Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score |
33.6; 6.3; -5.4 | — |
| SECONDARY Number of Participants With Relapse of Spasms |
— | — |
| SECONDARY Percentage of Participants With Relapse of Spasms |
— | — |
| SECONDARY Average Time to Cessation of Spasms |
— | — |
| SECONDARY Average Time to Relapse |
— | — |
Eligibility Criteria
Only participants who completed the pilot or pivotal phases of the trial may proceed to take part in this open-label extension phase of the trial.
Key eligibility criteria for the blinded phase were as follows:
Key Inclusion Criteria
- Participant is diagnosed with IS and has failed to respond adequately following treatment with 1 or more approved IS therapies.
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 (NCT02954887). 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.