Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy

NCT02726919 | Unknown Phase 4

• 1 other identifier: maes 007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to obtain pilot data on efficacy and safety of clobazam add-on treatment on adults with drug-resistant focal epilepsy. This will be an open label study comparing seizure frequency during 12 weeks of baseline observation period with seizure frequency during 16 weeks of clobazam adjunctive treatment. 10 adults aged 18-65 with focal seizures that have failed to respond to ≥ 4 antiepileptic drugs (AEDs) +/- respective surgery will be enrolled. Following a baseline of 12 weeks patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in whom seizure diaries have been kept prospectively prior to study screening visit, retrospective baseline will be accepted. Patients will be titrated up to either seizure freedom, to side effects or to 40 mg/day, whichever comes first. Titration rate will be not be forced. It is anticipated that the majority of subjects will have a 4 week-long titration period. After maximum dose is achieved, maintenance treatment will last for 12 weeks.

Conditions

Epilepsy

Keywords

focal epilepsy; clobazam

Outcome Measures

Primary Outcomes (1)

• seizure freedom

  seizure freedom for 3 months of maintenance treatment with the highest tolerated clobazam dose

  12 weeks

Secondary Outcomes (4)

• >75% seizure frequency reduction and median seizure frequency reduction for the whole treatment duration

  16 weeks

• median seizure frequency reduction for the whole treatment duration

  16 weeks

• comparing seizure frequency per 28 day periods during treatment vs. baseline

  16 weeks

• quality of life questionnaire (QOLIE-31-P) scores

  16 weeks

Study Arms (1)

Clobazam treatment

OTHER

This will be an open label study comparing seizure frequency during 12 weeks of baseline observation period with seizure frequency during 16 weeks of clobazam adjunctive treatment

Drug: Clobazam

Interventions

Clobazam DRUG

Following a baseline of 12 weeks patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in whom seizure diaries have been kept prospectively prior to study screening visit, retrospective baseline will be accepted. Patients will be titrated up to either seizure freedom, to side effects or to 40 mg/day, whichever comes first

Also known as: Onfi

Clobazam treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Stable focal epilepsy, with partial complex seizures including partial complex seizures with or without secondary generalization, partial simple seizures with a clear motor component with or without secondary generalization, and partial simple seizures with secondary generalization.
• Stable AED doses for at least 30 days
• Epilepsy duration for \> 2 years
• Past/current treatment with \> 4 AEDs. Vagal nerve stimulator treatment will be allowed and will not count as an AED. VNS setting must be stable for 3 months prior to enrollment.
• Seizure frequency of ≥1/month

You may not qualify if:

• Primary generalized epilepsy
• Simple partial seizures without motor components or secondary generalization
• Non-epileptic seizures
• Progressive neurological disease including neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
• Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease, other unstable metabolic or endocrine disturbances, and active systemic cancer
• Change in the dose of any Antiepileptic Drug within 30 days prior to enrollment
• Psychosis within six months of enrollment.
• Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
• Pregnancy
• Use of any CNS-active investigational drugs within 3 months of enrollment.
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• Pavel Klein: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

MidAtlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Interventions

Clobazam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pavel Klein, M.D.

  Mid-Atlantic Epilepsy and Sleep Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel Klein, M.D.

CONTACT

3015309744; kleinp@epilepsydc.com

Ivana Tyrlikova, M.D.

CONTACT

2404089665; tyrlikovai@epilepsydc.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: April 4, 2016
• Study Start: February 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 23, 2017

Record last verified: 2016-03

Locations

US (1)