Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

NCT02174094 | Withdrawn Phase 3 DMC

• 1 other identifier: 14362A
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

Conditions

Dravet Syndrome

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts

  Baseline and from week 0 to week 16

Secondary Outcomes (14)

• Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts during 4 weeks of maintenance

  Baseline and from week 4 to week 16

• Percent change in seizure rate for myoclonic seizures determined from daily seizure diary counts

  Baseline and from week 0 to week 16

• Percent change in seizure rate for atypical absence seizures determined from daily seizure diary counts

  Baseline and from week 0 to week 16

• Percent change in seizure rate for complex partial seizures determined from daily seizure diary counts

  Baseline and from week 0 to week 16

• Percent change in seizure rate for all seizure types determined from daily seizure diary counts

  Baseline and from week 0 to week 16

Study Arms (2)

Clobazam

EXPERIMENTAL

Clobazam - 1.0, 1.5 or 2.0 mg/kg/day (maximum 60 or 80 mg/day) twice daily (BID); Clobazam oral suspension 2.5 mg/mL, clobazam scored tablets 10 mg, orally

Drug: Clobazam

Placebo

PLACEBO COMPARATOR

Placebo to clobazam oral suspension 2.5 mg/mL and placebo to clobazam scored tablets 10 mg, orally

Drug: Placebo

Interventions

Clobazam DRUG

Also known as: Onfi®

Clobazam

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Onset of seizures in the first year of life
• History of fever-induced prolonged seizures as determined by the Investigator
• These may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
• Multiple seizure types which may include:
• myoclonic jerks/seizures
• history of normal development prior to seizure onset followed by development delay or regression after seizure onset
• abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) \[Vagal Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED\] 4. Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks

You may not qualify if:

• The patient is taking stiripentol, verapamil, or felbatol. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
• The patient is taking a sodium channel blocker including, but not limited to, phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 half-lives
• The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids
• The patient has received chronic treatment (≥2 weeks for any indication) with a benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for prolonged seizures is allowed
• The patient has received clobazam within 3 months prior to the Screening Visit. If the patient has received clobazam in the past, discontinuation must not have been for adverse events or lack of efficacy

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (9)

US010

Los Angeles, California, United States

Location

US001

Orlando, Florida, United States

Location

US003

Rochester, Minnesota, United States

Location

US005

Kansas City, Missouri, United States

Location

US0011

Dallas, Texas, United States

Location

US006

Dallas, Texas, United States

Location

US002

Houston, Texas, United States

Location

US004

Seattle, Washington, United States

Location

MX003

Guadalajara, Mexico

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic

Interventions

Clobazam

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 25, 2014
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (8); ME (1)