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NCT02911025 Clinical Trial

Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy

Epilepsy Clinical Trial

Official title:
Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02911025
Other study ID # 2014P001657
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date December 2017

Study information
Verified date February 2021
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.

Description:

Many studies show that patients with epilepsy frequently have disrupted sleep, as well as a high level of daytime sleepiness. This may be due to a sleep disorder, nighttime seizures that lead to disrupted sleep, and other abnormalities. Sleep complaints are widely reported among patients with various epilepsy syndromes. Anti-seizure treatments may affect sleep. Effects vary by type of medication and other health issues. Generally, with improvement of seizure control, the sleep cycle improves and becomes more regular. However, some anti-seizure medications have been associated with insomnia. There have been studies that looked at sleep in relation to some anti-seizure medications. However, there are no currently available published reports on the effect of Clobazam (Onfi) on sleep.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adults aged 18 years or older - diagnosis of epilepsy who are being considered for treatment with Clobazam Exclusion Criteria: - known untreated moderate or severe sleep apnea - major circadian rhythm disorders

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States Brigham and Women's Faulkner Hospital Jamaica Plain Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam The change in total sleep time in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose 1 week after reaching effective clobazam dose
Secondary Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam The change in wake after sleep onset (WASO) in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose 1 week after reaching effective clobazam dose
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