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

UCB

Status and phase

Terminated

Phase 2

Conditions

Infantile Spasms (IS)

Treatments

Drug: Radiprodil

Study type

Interventional

Funder types

Industry

Identifiers

NCT02829827

2016-002107-26 (EudraCT Number)

EP0078

Details and patient eligibility

About

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

Full description

The study is divided into 3 parts:

Part A - exploratory, Part B - confirmatory, Part C - open label extension

Enrollment

3 patients

Sex

All

Ages

2 to 14 months old

Volunteers

No Healthy Volunteers

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