TerminatedNCT02829827Updated Sep 17, 2019

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

A Phase 2 interventional study of Radiprodil in Infantile Spasms (IS), sponsored by UCB Biopharma S.P.R.L.. Terminated at 1 site in France. Open to participants aged 2 Months to 14 Months. Per ClinicalTrials.gov, last updated 2019-09-17.

Sponsored by UCB Biopharma S.P.R.L. · Phase 2, Interventional, and Treatment

Why this study was terminated

After reviewing the feasibility and projected completion date of the study, UCB has made the decision to stop the study

Phase: Phase 2
Study type: Interventional
Enrollment: 3
Allocation: Not applicable
Ages: 2 Months to 14 Months
Sex: All

Study 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

Read the detailed description

The study is divided into 3 parts:

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

Conditions studied

Infantile Spasms (IS)

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Keywords

Radiprodil
Infantile spasms
IS
Infantile
Spasms
Epilepsy
Paediatrics
Drug-resistant
West Syndrome
Hypsarrhythmia

In context

Muscle Cramp

95 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 85 interventional studies indexed under Muscle Cramp.

Browse Muscle Cramp studies →

Lead sponsor

UCB Biopharma S.P.R.L. is the lead sponsor of 46 studies on the registry; none are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Months to 14 Months
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 3 participants (actual)

Study arms

Experimental
Radiprodil
Each subject will enter an individualized dose titration schedule.
Drug: Radiprodil

Interventions

DrugRadiprodil
Radiprodil at individualized doses.

What researchers measure

Primary outcomes

Percentage of subjects with clinical response on Day 14 of treatment with the maintenance dose of radiprodil
Clinical response is defined as no spasms on Day 14 of treatment with the maintenance dose of radiprodil. This is the primary efficacy variable for Part A.
Time frame: Day 14, counting from the first day of radiprodil at maintenance dose
Estimates of exposure generated from a population-Pharmacokinetic modelling
This is a primary variable for Part A.
Time frame: Samples will be taken at baseline (time during Day -14 to -1 prior to dosing) and 3, 4, 5 & 12hr after the 1st dose on Day 1 of radiprodil low, mid & high dose. Blood samples will be taken at same timepoints after 1st dose on Day 2 of radiprodil low dose
Percentage of subjects with electro-clinical response on Day 14 of treatment with the maintenance dose of radiprodil
Electro-clinical response is defined as no spasms and resolution of hypsarrythmia on Day 14 of treatment with the maintenance dose of radiprodil. This is the primary efficacy variable for Part B.
Time frame: Day 14, counting from the first day of radiprodil at maintenance dose
Incidence of Adverse Events (AEs) during the study
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. This is a primary variable for all parts.
Time frame: From Baseline (Day -1) to the end of the Post-treatment Period (28 days post last dosing)

Secondary outcomes

Percentage of subjects with electro-clinical response on Day 14 of treatment with the maintenance dose of radiprodil
Electro-clinical response is defined as no spasms and resolution of hypsarrythmia on Day 14 of treatment with the maintenance dose of radiprodil. This is the secondary efficacy variable for Part A.
Time frame: Day 14, counting from the first day of radiprodil at maintenance dose
Percentage of subjects with clinical response on Day 14 of treatment with the maintenance dose of radiprodil
Clinical response is defined as no spasms on Day 14 of treatment with the maintenance dose of radiprodil. This is the secondary efficacy variable for Part B.
Time frame: Day 14, counting from Day 14 of treatment with the maintenance dose of radiprodil
Estimates of exposure generated from a population-Pharmacokinetic modelling
This is a secondary variable for Part B.
Time frame: Pharmacokinetic samples will be collected on Day 1 of radiprodil low dose, mid dose and high dose. Additionally, blood samples will be taken after 1st dose on Day 2 of radiprodil low dose.
Time to cessation of spasms
Time to cessation of spasms for clinical responders on Day 14 of treatment with the maintenance dose of radiprodol. This is a secondary efficacy variable for parts A and B.
Time frame: During the first 14 days of treatment with radiprodil
Percentage of responders with clinical relapse
The percentage of clinical responders on Day 14 of treatment with the maintenance dose of radiprodil with clinical relapse within 12 months. This is a secondary efficacy variable for parts A and B.
Time frame: 12 months, counting from Day 14 of treatment with the maintenance dose of radiprodil
Time to clinical relapse from the day of spasm cessation
This is a secondary efficacy variable for parts A and B.
Time frame: From day of spasms cessation up to 42 months of age
Percentage of electro-clinical responders with electro-clinical relapse
The percentage of electro-clinical responders on Day 14 of treatment with the maintenance dose of radiprodil with electro-clinical relapse within 12 months. This is a secondary efficacy variable for parts A and B.
Time frame: 12 months, counting from Day 14 of treatment with the maintenance dose of radiprodil
Time to electro-clinical relapse from the day of spasm cessation
This is a secondary efficacy variable for parts A and B.
Time frame: From day of spasms cessation up to 42 months of age
Percentage of subjects with extended clinical response
Extended clinical response is defined as no spasms for 28 consecutive days from Day 14 of treatment with the maintenance dose of radiprodil. This is a secondary efficacy variable for parts A and B.
Time frame: 28 days, counting from Day 14 (inclusive) of treatment with the maintenance dose of radiprodil
Percentage of subjects with extended electro-clinical response
Extended electro-clinical response is defined as no spasms and resolution of hypsarrythmia for 28 consecutive days from Day 14 of treatment with the maintenance dose of radiprodil. This is a secondary efficacy variable for parts A and B.
Time frame: 28 days, counting from Day 14 (inclusive) of treatment with the maintenance dose of radiprodil
Percentage of subjects with extended clinical response to each additional treatment cycle on Day 14 of treatment with the maintenance dose of radiprodil
Extended clinical response is defined as no spasms for 28 consecutive days from Day 14 of treatment with the maintenance dose of radiprodil. This is a secondary efficacy variable for part C.
Time frame: 28 days, counting from Day 14 (inclusive) of maintenance dose
Number of treatment cycles per subject
This is a secondary variable for Part C.
Time frame: During Part C (Day -1 to Day 28 of the Maintenance Period)
Percentage of subjects with electro-clinical response to each additional treatment cycle on Day 14 of treatment with the maintenance dose of radiprodil
Electro-clinical response is defined as no spasms and resolution of hypsarrythmia on Day 14 of treatment with the maintenance dose of radiprodil. This is a secondary efficacy variable for Part C.
Time frame: Day 14, counting from the first day of maintenance dose
Time to clinical relapse from the first day of no witnessed spasms for each treatment cycle
This is a secondary efficacy variable for part C.
Time frame: From day of no witnessed spasms up to 42 months of age

Study locations

1 site

Ep0078 401
Paris, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02829827
Lead sponsor: UCB Biopharma S.P.R.L.
Responsible party: Sponsor
First posted: Jul 12, 2016
Start date: Dec 4, 2017
Primary completion: Oct 2, 2018
Completion: Oct 2, 2018
Last update: Sep 17, 2019

Study contacts

UCB Cares

study director · +1 8445992273 (UCB)

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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