Trial record 8 of 17 for:
Lennox-Gastaut Syndrome
Clobazam in Subjects With Lennox-Gastaut Syndrome
This study has been completed.
Sponsor:
Lundbeck LLC
Information provided by (Responsible Party):
Lundbeck LLC
ClinicalTrials.gov Identifier:
NCT00162981
First received: September 9, 2005
Last updated: January 6, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy Epilepsy, Generalized Seizures |
Drug: Clobazam Low Dose Drug: Clobazam High Dose |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
Lennox-Gastaut syndrome
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Clobazam
U.S. FDA Resources
Further study details as provided by Lundbeck LLC:
Primary Outcome Measures:
- Percent Reduction in Number of Drop Seizures. [ Time Frame: 4-week baseline period and 4-week maintenance period ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
- Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. [ Time Frame: Week 3 ] [ Designated as safety issue: No ]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".
- Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. [ Time Frame: Week 7 ] [ Designated as safety issue: No ]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".
| Enrollment: | 68 |
| Study Start Date: | October 2005 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Clobazam Low Dose |
Drug: Clobazam Low Dose
5 to 10 mg/day with doses in the morning and at bedtime; orally
Other Name: Onfi™
|
| Experimental: Clobazam High Dose |
Drug: Clobazam High Dose
5 to 40 mg/day with doses in the morning and at bedtime; orally
Other Name: Onfi™
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 2 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162981
Locations
| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Pediatric Epilepsy & Neurology Specialists | |
| Tampa, Florida, United States, 33609 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Childrens Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Minnesota Epilepsy Group, P.A. | |
| St. Paul, Minnesota, United States, 55102 | |
| United States, Ohio | |
| Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Tennessee | |
| University of Tennessee Health Science Center | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Dallas Pediatric Neurology Associates | |
| Dallas, Texas, United States, 75230 | |
| Texas Child Neurology, LLP | |
| Plano, Texas, United States, 75075 | |
| United States, Virginia | |
| Monarch Medical Research | |
| Norfolk, Virginia, United States, 23510 | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53201 | |
Sponsors and Collaborators
Lundbeck LLC
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
Publications:
| Responsible Party: | Lundbeck LLC |
| ClinicalTrials.gov Identifier: | NCT00162981 History of Changes |
| Other Study ID Numbers: | 13108A, OV1002 |
| Study First Received: | September 9, 2005 |
| Results First Received: | November 7, 2011 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Epilepsy Epilepsy, Generalized Seizures Mental Retardation Spasms, Infantile Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Signs and Symptoms Neurobehavioral Manifestations Mental Disorders Diagnosed in Childhood Mental Disorders Clobazam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013