NCT03421496

A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Radius Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment of infants newly diagnosed with Infantile Spasms (IS).

Detailed description

This was a randomized, double-blind, placebo-controlled, parallel-group study in which participants were randomized in a 1:1 ratio to 1 of 2 treatment groups. During the Initial Treatment Period, participants received either vigabatrin plus CBD or vigabatrin plus matching placebo and were dosed approximately every 12 hours, with a meal. This study was comprised of five periods: Screening, Initial Treatment, Extended Treatment, Taper, and Follow up Periods, with a maximum duration of approximately 140 days.

Conditions

• Infantile Spasm

Interventions

Type	Name	Description
DRUG	Cannabidiol Oral Solution	An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
DRUG	Placebo	Matching oral solution
DRUG	Vigabatrin	Powder suspension

Timeline

• Start date: 2018-09-05
• Primary completion: 2019-05-29
• Completion: 2019-05-29
• First posted: 2018-02-05
• Last updated: 2023-06-07
• Results posted: 2023-06-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study