Trial Outcomes & Findings for A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms (NCT NCT03421496)
NCT ID: NCT03421496
Last Updated: 2023-06-07
Results Overview
Complete response is defined as complete resolution of spasms and hypsarrhythmia confirmed by 24-hour video-electroencephalogram (EEG).
TERMINATED
PHASE3
2 participants
Up to Day 15
2023-06-07
Participant Flow
This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
This study was comprised of five periods. The Screening Period lasted up to 14 days, the Initial Treatment period lasted up to 15 days, the Extended Treatment period lasted up to 75 days, followed by a 6-day Taper period and a 30 day Follow up period, with a maximum duration of approximately 140 days.
Participant milestones
| Measure |
CBD With Vigabatrin
Participants received up to 40 mg/kg/day twice daily (BID) of CBD orally with food during the 15-day Initial Treatment Period. Participants also received up to 150 mg/kg/day BID of vigabatrin orally with food. During the Extended Treatment Period, complete responders continued their assigned treatment of vigabatrin plus CBD 40 mg/kg/day up to Day 75.
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Placebo With Vigabatrin
Participants received a matching placebo to CBD, orally with food during the 15-day Initial Treatment Period. Participants also received up to 150 mg/kg/day BID of vigabatrin orally with food. During the Extended Treatment Period, complete responders continued their assigned treatment of vigabatrin plus matching placebo up to Day 75.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to Day 15Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Complete response is defined as complete resolution of spasms and hypsarrhythmia confirmed by 24-hour video-electroencephalogram (EEG).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 15Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Resolution of IS was assessed by 24-hour video-EEG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 15Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Resolution of hypsarrhythmia was assessed by 24-hour video-EEG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Investigators will use the CGI-I scale, which is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and is rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher scores indicated worse condition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 15Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Increase in spasm-free days will be determined by seizure diary entries.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 75Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Relapse during the extended treatment period will be confirmed by video-EEG following parent report of relapse.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 75Population: This study was terminated by the Sponsor. The Sponsor terminated the study due to slow enrollment and a failure to identify adequate participants that met eligibility criteria. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Outcome measures
Outcome data not reported
Adverse Events
CBD With Vigabatrin
Placebo With Vigabatrin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bruce Mitlak, MD; Head of Discovery Science and Chief Medical Officer
Radius Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place