Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome
- Conditions
- ennox-Gastaut syndromeMedDRA version: 9.1Level: LLTClassification code 10048816Term: Lennox-Gastaut syndrome
- Registration Number
- EUCTR2007-004350-82-BG
- Lead Sponsor
- Ovation Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 304
1) The subject or subject's legally authorized representative must sign and date the
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
Informed Consent Form (ICF)/Health Insurance Portability and Accountability Act
(HIPAA) Authorization prior to study participation.
2) Previous participation in an Ovation sponsored LGS study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Greater than 14 days have elapsed since the subject received his/her last dose of
study medication in the previous Ovation-sponsored LGS study.
Subject had a serious or severe adverse event in the previous Ovation sponsored
LGS study that in the opinion of the investigator was probably or definitely related
to clobazam use and precludes safe use of clobazam.
Subject has had an anoxic episode requiring resuscitation within 1 year of study
entry.
Subject has a history of an allergic reaction or significant sensitivity to
benzodiazepines.
Subject is taking more than 3 concurrent anti epileptic drugs (AEDs). NOTE: Vagal Nerve Stimulator (VNS) or ketogenic diet is allowed and will not be counted in the three allowed AEDs.
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 idiopathic nephrotic syndrome or asthma.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method