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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00162981
Other study ID # 13108A
Secondary ID OV1002
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated January 6, 2012
Start date October 2005
Est. completion date October 2006

Study information

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

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Clobazam Low Dose
5 to 10 mg/day with doses in the morning and at bedtime; orally
Clobazam High Dose
5 to 40 mg/day with doses in the morning and at bedtime; orally

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Lundbeck LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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