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Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy

NCT02726919 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-23

No results posted yet for this study

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

Interventions

DRUG

Clobazam

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Pavel Klein

    lead OTHER

Principal Investigators

  • Pavel Klein, M.D. · Mid-Atlantic Epilepsy and Sleep Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02726919 on ClinicalTrials.gov