Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome (NCT01160770) | Clinical Trial Compass
CompletedPhase 3
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome
267 participantsStarted 2005-12
Plain-language 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.
Who can participate
Age range2 Years – 60 Years
SexALL
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Inclusion Criteria:
* The subject or subject's legally authorized representative (LAR) must sign and date the institutional review board (IRB)/independent ethics committee (IEC) approved Informed Consent Form/Health Insurance Portability and Accountability Act (HIPAA) Authorization (if required) prior to study participation.
* Previous participation in Lundbeck-sponsored LGS study.
* Subject must weigh ≥12.5 kilograms.
* Male or female subjects must have been between 2 and 60 years of age at the time of the enrollment in the Phase 3 double-blind study (13110A/OV1012/NCT00518713) or between 2 and 30 years of age at the time of the enrollment in the Phase 2 double-blind study (13108A/OV1002/NCT00162981) study.
* If female:
* Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if of childbearing potential, must comply with a method of birth control acceptable to the investigator during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study.
* Subject is not breastfeeding.
* Subjects of childbearing potential must have a negative serum pregnancy test at Study Day 1.
* In the investigator's opinion, parent or caregiver must be able to keep an accurate seizure diary.
Exclusion Criteria:
* Greater than 14 days have elapsed since the subject received his/her last dose of study me…
What they're measuring
1
Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment
Timeframe: Baseline to month 36
2
Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment