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Clobazam in Subjects With Lennox-Gastaut Syndrome

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ClinicalTrials.gov Identifier: NCT00162981
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : February 9, 2012
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Lundbeck LLC

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Results First Submitted Date  ICMJE November 7, 2011
Results First Posted Date  ICMJE February 9, 2012
Last Update Posted Date February 9, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
  • Percent Reduction in Number of Drop Seizures. [ Time Frame: 4-week baseline period and 4-week maintenance period ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Percent reduction in number of drop seizures from the baseline period compared to the maintenance period.
Change History Complete list of historical versions of study NCT00162981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
  • 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 ]
    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 ]
    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 ]
    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".
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Percent of subjects considered treatment responders defined as those with a >/= 25%, >/= 50%, >/= 75% reduction in drop seizures from the baseline period compared to the maintenance period.
  • Parent/Caregiver global evaluations of seizure activity and quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clobazam in Subjects With Lennox-Gastaut Syndrome
Official Title  ICMJE Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Epilepsy, Generalized
  • Seizures
Intervention  ICMJE
  • Drug: Clobazam Low Dose
    5 to 10 mg/day with doses in the morning and at bedtime; orally
    Other Name: Onfi™
  • Drug: Clobazam High Dose
    5 to 40 mg/day with doses in the morning and at bedtime; orally
    Other Name: Onfi™
Study Arms  ICMJE
  • Experimental: Clobazam Low Dose
    Intervention: Drug: Clobazam Low Dose
  • Experimental: Clobazam High Dose
    Intervention: Drug: Clobazam High Dose
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2009)
68
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
60
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162981
Other Study ID Numbers  ICMJE 13108A
OV1002 ( Other Identifier: Former study ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lundbeck LLC
Study Sponsor  ICMJE Lundbeck LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account Lundbeck LLC
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP