Clobazam in Subjects With Lennox-Gastaut Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00162981
• Date of registration: 09/09/2005
• Prospective Registration: Yes
• Primary sponsor: Lundbeck LLC
• Public title: Clobazam in Subjects With Lennox-Gastaut Syndrome
• Scientific title: Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
• Date of first enrolment: October 2005
• Target sample size: 68
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00162981
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & 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



Age minimum: 2 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy, Generalized

Seizures

Epilepsy

Intervention(s)

Drug: Clobazam High Dose

Drug: Clobazam Low Dose

Primary Outcome(s)

Percent Reduction in Number of Drop Seizures. [Time Frame: 4-week baseline period and 4-week maintenance period]

A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. [Time Frame: 4-week baseline period and the 4-week maintenance period]

Secondary Outcome(s)

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. [Time Frame: Week 3]

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. [Time Frame: Week 7]

Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. [Time Frame: 4-week baseline period and 4-week maintenance period]

Secondary ID(s)

OV1002

13108A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/02/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00162981