Clobazam in Subjects With Lennox-Gastaut Syndrome

Lundbeck

Status and phase

Completed

Phase 2

Conditions

Epilepsy, Generalized

Seizures

Epilepsy

Treatments

Drug: Clobazam High Dose

Drug: Clobazam Low Dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT00162981

OV1002 (Other Identifier)

13108A

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

Full description

LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment.

More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.

Enrollment

68 patients

Sex

All

Ages

2 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Subject must have been <11 years of age at the onset of LGS
Subject must have LGS
Subject must be on at least 1 stable dose AED
Parent or caregiver must be able to keep an accurate seizure diary

Key Exclusion Criteria:

Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation
Subject has had an episode of status epilepticus within 12 weeks of baseline
Subject has had an anoxic episode requiring resuscitation within 1 year of screening
Subject has had a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines
Subject is taking more than 3 concurrent AEDs. Note: Vagal Nerve Stimulation (VNS) or ketogenic diet is allowed and each will be counted as one of the three allowed AEDs
If the subject is on the ketogenic diet, has been for less than 4 weeks prior to screening or suffers from frequent stooling
If the subject has a VNS, the settings have not been stable for at least 4 weeks prior to screening
Subject has taken corticotropins in the 6 months prior to screening
Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for urinary tract infections or asthma
If the subject is taking felbamate, has been taking it for less than 1 year prior to screening or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events