Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome

Conditions: ennox-Gastaut syndrome
MedDRA version: 9.1Level: LLTClassification code 10048816Term: Lennox-Gastaut syndrome

Registration Number: EUCTR2007-004350-82-LT

Lead Sponsor: undbeck Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 304

Inclusion Criteria

1) The subject or subject’s LAR must sign and date the IRB/IEC approved Informed Consent Form/HIPAA Authorization (if required) prior to study participation.
2) Previous participation in Ovation-sponsored LGS study.
3) Subject must weigh greater or equal 12.5 kilograms.
4) 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 (protocol number OV-1012) or between 2 and 30 years of age at the time of the enrollment in the Phase 2 double-blind study (protocol number OV-1002) study.
5) If female:
a. 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.
b. Subject is not breastfeeding.
c. Subjects of childbearing potential must have a negative serum pregnancy test at Study Day 1.
6) In the investigator’s opinion, parent or caregiver must be able to keep an accurate seizure diary.

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

Exclusion Criteria

1) Greater than 14 days have elapsed since the subject received his/her last dose of study medication in the previous Ovation-sponsored LGS study.
2) 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.
3) Subject has had an anoxic episode requiring resuscitation within 6 months of study entry.
4) Subject has a history of an allergic reaction or significant sensitivity to benzodiazepines or to any of the other ingredients in clobazam tablets.
5) Subject is taking more than 3 concurrent AEDs. NOTE: Vagal Nerve Stimulator (VNS) or ketogenic diet is allowed and will not be counted in the three allowed AEDs.
6) 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.
7) If the subject is taking felbamate, has been taking it for less than 1 year prior to study entry or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events.
8) Subject has experienced an idiosyncratic reaction to an AED, e.g., carbamazepine with resulting aplastic anemia or agranulocytosis, topiramate with resulting metabolic acidosis, felbamate with resulting aplastic anemia or hepatic failure, or lamotrigine with resulting skin irritation and/or rash.
9) Subject has shown any clinically significant history of hyper-sensitivity to CNS-active medications leading to neurobehavioral aberrations (e.g., increased biting, scratching, kicking, or hitting).
10) Subject has taken or used any investigational drug or device in the 30 days prior to screening, with the exception of clobazam in an Ovation-sponsored study.
11) Subject has a clinically significant unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, or pulmonary disease or ongoing malignancy.
12) Subject has a diagnosis of sleep apnea.
13) Subject has a compromised respiratory function or severe respiratory insufficiency.
14) Subject has a history of severe muscle weakness, including myasthenia gravis.
15) Subject has a clinically significant abnormal laboratory value or electrocardiogram (ECG) abnormality.
16) Subject has progressive lesion confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
17) Subject has a history of drug or alcohol abuse.
18) Subject has a history of poor compliance on past antiepileptic therapy.
19) Subject has inadequate supervision by parent or guardian.
20) For any reason, the subject is considered by the investigator to be an unsuitable candidate for the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the long-term safety and effectiveness of open-label clobazam in<br>the treatment of seizures in subjects with Lennox-Gastaut Syndrome (LGS).<br>;Secondary Objective: ;Primary end point(s): Percent reduction at various time intervals in number of drop seizures (average per week in the week preceding each study visit) compared to the baseline period of the study from which the subject rolled over (previous Ovation sponsored study)

Secondary Outcome Measures