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

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-05
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Part A and Part 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

Part A and Part 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