A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)

• Status: Terminated
• Trial end date: 2018-10-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.

Criteria

Inclusion Criteria:

Part 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

Exclusion Criteria:

Part A and B:

• More than 6 months have passed since the diagnosis of Infantile Spasms (IS)

• Current treatment with cannabinoids

• 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

• Current treatment with perampanel

• 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 such as non-ketotic hyperglycinemia

• Body weight is below 4 kg

• Known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias

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