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

Phase 1

• Conditions: Infantile spasms (IS); MedDRA version: 20.0 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-FR
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Study Completion: 2018-10-02
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

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

Inclusion Criteria

- Subject is male or female between 2 and 14 months of age
- Onset of spasms has occurred within 3 months of study start
- The diagnosis of infantile spasms (IS)
- Subject has drug-resistant IS
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

- 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
- Concomitant treatment with felbamate
- Ketogenic diet
- Previous treatment for IS other than Standard-of-Care (StoC)
- 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

Study & Design

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