Trials / Terminated
TerminatedNCT02829827
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)
An Open-label Adaptive Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Radiprodil in Subjects With Drug-resistant Infantile Spasms
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 2 Months – 14 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms
Detailed description
The study is divided into 3 parts: Part A - exploratory, Part B - confirmatory, Part C - open label extension
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radiprodil | Radiprodil at individualized doses. |
Timeline
- Start date
- 2017-12-04
- Primary completion
- 2018-10-02
- Completion
- 2018-10-02
- First posted
- 2016-07-12
- Last updated
- 2019-09-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02829827. Inclusion in this directory is not an endorsement.