Epilepsy Clinical Trial
Official title:
Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
Verified date | January 2012 |
Source | Lundbeck LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | October 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 30 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Childrens Hospital Boston | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Children's Hospital | Columbus | Ohio |
United States | Dallas Pediatric Neurology Associates | Dallas | Texas |
United States | Childrens Hospital Los Angeles | Los Angeles | California |
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | Monarch Medical Research | Norfolk | Virginia |
United States | Barrow Neurological Institute | Phoenix | Arizona |
United States | Texas Child Neurology, LLP | Plano | Texas |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Minnesota Epilepsy Group, P.A. | St. Paul | Minnesota |
United States | Pediatric Epilepsy & Neurology Specialists | Tampa | Florida |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Lundbeck LLC |
United States,
Conry JA, Ng YT, Paolicchi JM, Kernitsky L, Mitchell WG, Ritter FJ, Collins SD, Tracy K, Kormany WN, Abdulnabi R, Riley B, Stolle J. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia. 2009 May;50(5):1158-66. doi: 10.1111/j.1528-1167.2008.01935.x. Epub 2008 Dec 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Reduction in Number of Drop Seizures. | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and 4-week maintenance period | No |
Primary | A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and the 4-week maintenance period | No |
Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. | 4-week baseline period and 4-week maintenance period | No |
Secondary | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". | Week 3 | No |
Secondary | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". | Week 7 | No |
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