A phase 2 study of Radiprodil in subjects with drug-resistant infantile spasms (IS)

Phase 1

• Conditions: Infantile spasms (IS); MedDRA version: 20.1 Level: PT Classification code 10021750 Term: Infantile spasms System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002107-26-DE
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-25
• Study Completion: 2018-10-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

Parts A and B:
- Subject is male or female between 2 and 14 months of age
- The diagnosis of infantile spasms (IS)
- Subject has drug-resistant IS

Part C:
- Subject participated in EP0078 Part A and received 2 radiprodil
treatment cycles
- Subject experienced a relapse of spasms during the down taper or
within 5 half-lives (3 days) discontinuation of radiprodil treatment in
Cycle 2 of Part A
- Electroencephalogram (EEG) on baseline Part C is compatible with the
diagnosis of infantile spasms

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Parts A and B:
- More than 6 months have passed since the diagnosis of IS.
- Subject has hematocrit greater than 60
- Subject has any medical condition that, in the opinion of the Investigator, could jeopardize or would
compromise the subject’s ability to participate in this study
- Subject has a history or current condition predisposing to respiratory dysfunction
- Current treatment with felbamate
- Ketogenic diet
- Clinically significant lab abnormalities
- Clinically significant abnormality on ECG that, in the opinion of the Investigator, increases the safety risks of participating in the study
- Subject has a lethal or potentially lethal condition other than IS, with a significant risk of death before 18 months of age
- Body weight is below 4 kg
- Known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias
- Current treatment with perampanel
- Current treatment with cannabinoids

Part C:
- Subject experienced any acute tolerability issues in either treatment
cycle in Part A which the investigator and the sponsor medical monitor
consider a risk for further participation
- Subject met any withdrawal criteria in Part A
- Subject has experienced any adverse effects or developed any new
medical conditions since enrollment in Part A which the investigator
considers could significantly increase the safety risks of participating in Part C

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified