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

NCT02911025 | Completed Results

• 1 other identifier: 2014P001657
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Epilepsy

Keywords

epilepsy; sleep; antiepileptic drugs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam

  1 week after reaching effective clobazam dose

Study Arms (1)

Patients Treated With Clobazam

Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.

Eligibility Criteria

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

Study Population

Adults with Epilepsy who have recently been started on Clobazam (Onfi)

You may qualify if:

• adults aged 18 years or older
• diagnosis of epilepsy who are being considered for treatment with Clobazam

You may not qualify if:

• known untreated moderate or severe sleep apnea
• major circadian rhythm disorders

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Jamaica Plain, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Milena Pavlova
• Organization: Brigham and Women's Hospital

mpavlova@bwh.harvard.edu

6174772129

Study Officials

• Milena Pavlova, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard Medical School

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: September 22, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)