Clinical Trial: Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

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

Official Title: Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

Brief Summary: The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.

Detailed Summary: This multi-center, open-label study is designed to evaluate the long-term safety and effectiveness of clobazam as adjunctive therapy in subjects with LGS. Subjects enrolled in Lundbeck LLC (formerly Ovation Pharmaceuticals, Inc.) sponsored studies 13108A/OV1002/NCT00162981 and 13110A/OV1012/NCT00518713 who either completed the study or who prematurely discontinued were offered the opportunity to rollover into this open-label study. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After 48 hours, investigators will be able to increase, decrease or maintain the subject's dose, up to a maximum target daily dose of 2.0 mg/kg (maximum dose of 80 mg/day). During the treatment period, seizures will be recorded during the week preceding each study visit or 30 days immediately following each study visit (dependent on Amendment approval). The subject or subject's caregiver will record daily counts of seizures, including drop seizures in the subject's seizure diary.
Sponsor: Lundbeck LLC

Current Primary Outcome:

  • Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment [ Time Frame: Baseline to month 36 ]
    Number of drop seizures was obtained from seizure diaries
  • Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment [ Time Frame: Baseline to month 36 ]
    Number of drop seizures was obtained from seizure diaries


Original Primary Outcome: Safety: Lab assessments, vital signs, physical & neurological exams, & ongoing AE assessment. Effectiveness: % reduction at various time intervals in # of drop seizures compared to the baseline period of the study from which the subject [ Time Frame: Up to 60 months ]

Reduction in seizures compared to the baseline period measured at various time intervals throughout the study


Current Secondary Outcome:

  • Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment [ Time Frame: Baseline to month 36 ]
    Number of drop seizures obtained from seizure diaries
  • Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment [ Time Frame: Baseline to month 36 ]
    Number of drop seizures obtained from seizure diaries
  • Investigator Global Evaluations of the Patient's Overall Change in Symptoms [ Time Frame: Baseline to month 36 ]
    The physician was asked to rate the patient's overall change in symptoms 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: Baseline to month 36 ]
    The parent/caregiver was asked to rate the patient's overall change in symptoms 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:

  • % subjects at various time intervals considered treatment responders: those with >=25%, >=50%, >=75% &100% reduction in drop seizures from their previous study baseline. [ Time Frame: Up to 60 months ]
  • Investigator & caregiver global evaluations of the subject's overall change in symptoms. [ Time Frame: Up to 60 months ]
  • Changes in the use of other antiepileptic drugs (AEDs). [ Time Frame: Up to 60 months ]


Information By: Lundbeck LLC

Dates:
Date Received: June 18, 2010
Date Started: December 2005
Date Completion:
Last Updated: March 22, 2013
Last Verified: March 2013