Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2022
• Main ID: NCT02953548
• Date of registration: 01/11/2016
• Prospective Registration: Yes
• Primary sponsor: Jazz Pharmaceuticals
• Public title: Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
• Scientific title: A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study
• Date of first enrolment: April 24, 2017
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02953548
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Poland, United States

Key inclusion & exclusion 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.



Age minimum: 1 Month
Age maximum: 24 Months
Gender: All

Health Condition(s) or Problem(s) studied

Infantile Spasms

Intervention(s)

Drug: GWP42003-P

Primary Outcome(s)

Number of Participants With Clinically Significant Vital Sign Findings [Time Frame: From signing of informed consent up to Day 15]

Number of Participants With Clinically Significant Physical Examination Findings [Time Frame: From signing of informed consent up to Day 15]

Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value [Time Frame: Day 4 and Day 15]

Number of Participants With Any Low or High Hematology Laboratory Parameter Value [Time Frame: Day 4 and Day 15]

Number of Participant With Any Clinically Relevant Urinalysis Parameter Value [Time Frame: Day 4 and Day 15]

Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) [Time Frame: From signing of informed consent up to Day 15]

Number of Participants With Clinically Significant Electrocardiogram Findings [Time Frame: From signing of informed consent up to Day 15]

Secondary Outcome(s)

Number of Participants With Resolution of Hypsarrhythmia [Time Frame: Day 15]

Percentage of Participants Free of Clinical Spasms [Time Frame: Day 15]

Percentage of Responders [Time Frame: Baseline to Day 15]

Physician Global Impression of Change (PGIC) [Time Frame: Day 15]

Percentage of Participants With Resolution of Hypsarrhythmia [Time Frame: Day 15]

Average Time to Cessation of Spasms [Time Frame: Day 1 to start of Open-label Extension (OLE) Phase]

Caregiver Clinical Global Impression of Change (CGIC) [Time Frame: Day 15]

Number of Participants Experiencing Spasms and Seizures by Subtype [Time Frame: Day 4 and Day 15]

Number of Responders [Time Frame: Baseline to Day 15]

Number of Participants Free of Clinical Spasms [Time Frame: Day 15]

Secondary ID(s)

2015-004904-50

GWEP15100 Pilot Phase

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02953548