Lennox-Gastaut Syndrome MedDRA version: 9.1 Level: LLT Classification code 10048816 Term: Lennox-Gastaut syndrome
Conditions
Interventions
Trade Name: Clobazam
Product Name: Clobazam Tablets 5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Clobazam
CAS Number: 22316-47-8
Other descriptive name: Clobazam PhEur
Concentration unit: mg m
Sponsors
Lundbeck Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient or patient?s legally authorized representative (LAR) 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 (if required) prior to study participation. If appropriate, the patient will sign an Assent Form. 2. Male or female patients between 2 and 60 years of age (inclusive). 3. Patient must have been =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Etiology of patient?s seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor. 2. Patient has had an episode of status epilepticus within 12 weeks of baseline. 3. Patient has had an anoxic episode requiring resuscitation within 6 months of screening. 4. Patient has a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines or to any of the other ingredients in clobazam tablets. 5. Patient is taking more than 3 concurrent AEDs. NOTE: VNS or ketogenic diet is allowed and will not be counted in the three allowed AEDs. 6. Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers from frequent stooling. 7. If the patient has a VNS, the settings have not been stable for at least 30 days prior to screening. 8. Patient has previously been treated with CLB. 9. Patient has taken corticotropins in the 6 months prior to screening. 10. Patient 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. 11. If the patient is taking felbamate, he/she has been taking it for less than 1 year prior to screening. 12. Patient has experienced a clinically significant unresolved idiosyncratic reaction to an AED, e.g., topiramate with resulting metabolic acidosis, felbamate with resulting aplastic anemia or hepatic failure, or lamotrigine with resulting skin irritation and/or rash. 13. Patient has shown any clinically significant history of hyper-sensitivity to central nervous system (CNS)-active medications leading to neurobehavioral aberrations (e.g., increased biting, scratching, kicking or hitting). 14. If the patient is on any chronic medication, the dose has not been stable for at least 30 days prior to screening. 15. Patient has taken or used any investigational drug or device in the 30 days prior to screening. 16. Patient has a clinically significant unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, or pulmonary disease or ongoing malignancy. 17. Patient has a diagnosis of sleep apnea. 18. Patient has compromised respiratory function or severe respiratory insufficiency. 19. Patient has a clinically significant abnormal laboratory value. 20. Patient has familial long QT syndrome, QT/QTc >500msec or a history of polymorphic ventricular tachycardia. 21. Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan. 22. Patient has a history of drug or alcohol abuse. 23. Patient has a history of poor compliance on past antiepileptic therapy. 24. Patient has inadequate supervision by parent or guardian. 25. For any reason, the patient is considered by the investigator to be an unsuitable candidate for the study. 26. Patient has a history of severe muscle weakness, including myasthenia gravis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the efficacy of clobazam (CLB) in the reduction of drop seizures at three dose levels when compared to baseline during 12 weeks maintenance dosing in a placebo controlled trial in patients with Lennox-Gastaut Syndrome (LGS). 2. To determine the safety of CLB when administered for up to 18 weeks at three different dose levels in patients with LGS.;Secondary Objective: 1. To determine the efficacy of CLB as determined by responder rates and global evaluation of patient symptoms. 2. To determine population pharmacokinetic (PPK) parameters of CLB and its active metabolite N-desmethylclobazam (N-CLB) at steady-state dosing of CLB in patients with LGS and to describe sources of inter-patient variability (co-variates) including patient demographics, concomitant antiepileptic drug (AED) medications and genotype. 3. To evaluate the development of tolerance during treatment for up to 12 weeks. 4. To determine the effect of CLB on behavior utilizing the Child Behavior Checklist (CBCL). 5. To determine the impact of CLB on behavioral, cognitive and physical/neurologic disability through use of the Impact of Childhood Neurologic Disability Scale (ICNDS).;Primary end point(s): Percent reduction in number of drop seizures (average per week) from the 4-week baseline period compared to the 12-week maintenance period. | — |
Countries
Bulgaria, Lithuania
Outcome results
None listed