Trial · NCT03421496
A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
NCT03421496, Phase 3, Terminated, Radius Pharmaceuticals, Inc.; results first posted 2023-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms. Trials, record NCT03421496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03421496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
- NCT number
- NCT03421496
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2 participants, actual
- Lead sponsor
- Radius Pharmaceuticals, Inc.
- Conditions
- Infantile Spasm
- Interventions
- Cannabidiol Oral Solution, Placebo, Vigabatrin
- First posted
- 2018-02-05
- Last updated
- 2023-06-07
- Results first posted
- 2023-06-07
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Considered Complete Responders | Up to Day 15 | Complete response is defined as complete resolution of spasms and hypsarrhythmia confirmed by 24-hour video-electroencephalogram (EEG). |
| Secondary | Percentage of Participants With Resolution of Infantile Spasms | Up to Day 15 | Resolution of IS was assessed by 24-hour video-EEG. |
| Secondary | Percentage of Participants With Resolution of Hypsarrhythmia | Up to Day 15 | Resolution of hypsarrhythmia was assessed by 24-hour video-EEG. |
| Secondary | Investigator Impression of Efficacy and Tolerability of Study Drug Clinical Global Impression- Global Improvement (CGI-I) | Day 15 | 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. |
| Secondary | Percentage of Participants With Increase in Number of Spasm-Free Days Between Day 1 and Day 15 | Up to Day 15 | Increase in spasm-free days will be determined by seizure diary entries. |
| Secondary | Percentage of Participants With Complete Response During the Initial Treatment Period Who Relapse During the Extended Treatment Period | Up to Day 75 | Relapse during the extended treatment period will be confirmed by video-EEG following parent report of relapse. |
| Secondary | Time to Relapse During the Extended Treatment Period | Up to Day 75 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Considered Complete Responders | Up to Day 15 | 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. | ||
| SECONDARY | Percentage of Participants With Resolution of Infantile Spasms | Up to Day 15 | 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. | ||
| SECONDARY | Percentage of Participants With Resolution of Hypsarrhythmia | Up to Day 15 | 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. | ||
| SECONDARY | Investigator Impression of Efficacy and Tolerability of Study Drug Clinical Global Impression- Global Improvement (CGI-I) | Day 15 | 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. | ||
| SECONDARY | Percentage of Participants With Increase in Number of Spasm-Free Days Between Day 1 and Day 15 | Up to Day 15 | 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. | ||
| SECONDARY | Percentage of Participants With Complete Response During the Initial Treatment Period Who Relapse During the Extended Treatment Period | Up to Day 75 | 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. | ||
| SECONDARY | Time to Relapse During the Extended Treatment Period | Up to Day 75 | 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. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CBD With Vigabatrin | 0 | |
| Overall Study | STARTED | Placebo With Vigabatrin | 0 | |
| Overall Study | COMPLETED | CBD With Vigabatrin | 0 | |
| Overall Study | COMPLETED | Placebo With Vigabatrin | 0 | |
| Overall Study | NOT COMPLETED | CBD With Vigabatrin | 0 | |
| Overall Study | NOT COMPLETED | Placebo With Vigabatrin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CBD With Vigabatrin | 0 | 0 |
| Total, all-cause mortality | Placebo With Vigabatrin | 0 | 0 |
| Total, other adverse events | CBD With Vigabatrin | 0 | 0 |
| Total, other adverse events | Placebo With Vigabatrin | 0 | 0 |
| Total, serious adverse events | CBD With Vigabatrin | 0 | 0 |
| Total, serious adverse events | Placebo With Vigabatrin | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03421496
GET https://conductscience.org/api/trials/v1/NCT03421496/registered