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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00518713
Date of registration: 20/08/2007
Prospective Registration: Yes
Primary sponsor: Lundbeck LLC
Public title: Clobazam in Patients With Lennox-Gastaut Syndrome
Scientific title: Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome
Date of first enrolment: August 2007
Target sample size: 238
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00518713
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Australia Belarus India Lithuania Serbia United States
Contacts
Name:     Email contact via H. Lundbeck A/S
Address: 
Telephone:
Email:
Affiliation:  LundbeckClinicalTrials@lundbeck.com
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient must have been <11 years of age at the onset of LGS.

- Patient must have LGS.

- Patient must be on at least 1 AED.

- Parent or caregiver must be able to keep an accurate seizure diary.

Exclusion Criteria:

- Etiology of patient's seizures is a progressive neurologic disease. Patients with
tuberous sclerosis will not be excluded from study participation, unless there is a
progressive tumor.

- Patient has had an episode of status epilepticus within 12 weeks of baseline.

- Patient has had an anoxic episode requiring resuscitation within 6 months of
screening.

- Patient has a clinically significant history of an allergic reaction or significant
sensitivity to benzodiazepines.

- Patient is taking more than 3 concurrent AEDs.

- Patient has been on the ketogenic diet for less than 30 days prior to screening or
suffers from frequent stooling.

- If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stable
for at least 30 days prior to screening.

- Patient has taken corticotropins in the 6 months prior to screening.

- Patient is currently taking long-term systemic steroids (excluding inhaled mediation
for asthma treatment) or any other daily medication known to exacerbate epilepsy. An
exception will be made of prophylactic medication, for example, for idiopathic
nephrotic syndrome or asthma.

- If the patient is taking felbamate, has been taking it for less than 1 year prior to
screening.

Other protocol-defined inclusion and exclusion criteria may apply.



Age minimum: 2 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Epilepsy
Epilepsy, Generalized
Seizures
Intervention(s)
Drug: Clobazam High Dose
Drug: Clobazam Low Dose
Drug: Clobazam Medium Dose
Drug: Placebo
Primary Outcome(s)
Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). [Time Frame: 4-week baseline period and 12-week maintenance period]
Secondary Outcome(s)
Investigator Global Evaluations of the Patient's Overall Change in Symptoms. [Time Frame: Week 15]
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. [Time Frame: Week 15]
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period). [Time Frame: 4-week baseline period and the 12-week maintenance period]
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). [Time Frame: 4-week baseline period and the first 4 weeks of the 12-week maintenance period]
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). [Time Frame: 4-week baseline period and the last 4 weeks of the 12-week maintenance period]
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). [Time Frame: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period]
Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). [Time Frame: 4-week baseline period and the first 4 weeks of the 12-week maintenance period]
Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). [Time Frame: 4-week baseline period and the last 4 weeks of the 12-week maintenance period]
Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). [Time Frame: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period]
Tolerance [Time Frame: 4-week baseline period and first 4/first 8 weeks of the maintenance period]
Secondary ID(s)
13110A
OV1012
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 09/02/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00518713
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