Clinical Trial: Clobazam in Subjects With Lennox-Gastaut Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.

Sponsor: Lundbeck LLC

Current Primary Outcome:

• 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: Percent reduction in number of drop seizures from the baseline period compared to the maintenance period.

Current Secondary Outcome:

• 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:

• 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.

Information By: Lundbeck LLC

Dates:
Date Received: September 9, 2005
Date Started: October 2005
Date Completion:
Last Updated: January 6, 2012
Last Verified: January 2012