A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
Public ClinicalTrials.gov record NCT03421496. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms
Study identification
- NCT ID
- NCT03421496
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Radius Pharmaceuticals, Inc.
- Industry
- Enrollment
- 2 participants
Conditions and interventions
Conditions
Interventions
- Cannabidiol Oral Solution Drug
- Placebo Drug
- Vigabatrin Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Month to 24 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 4, 2018
- Primary completion
- May 28, 2019
- Completion
- May 28, 2019
- Last update posted
- Jun 6, 2023
2018 – 2019
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Beaumont Children's Hospital | Royal Oak | Michigan | 48073 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Institute for Research and Innovation | MultiCare Health System | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03421496, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 6, 2023 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03421496 live on ClinicalTrials.gov.