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

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ClinicalTrials.gov Identifier: NCT02911025
Recruitment Status : Unknown
Verified October 2016 by Pavlova, Milena,M.D., Brigham and Women's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : September 22, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Pavlova, Milena,M.D., Brigham and Women's Hospital

Tracking Information
First Submitted Date January 11, 2016
First Posted Date September 22, 2016
Last Update Posted Date October 21, 2016
Study Start Date January 2015
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2016)
Change in sleep (total sleep time, wake after sleep onset) in patients with epilepsy treated with clobazam [ Time Frame: 1 week after reaching effective clobazam dose ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02911025 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
Official Title Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
Brief Summary The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with Epilepsy who have recently been started on Clobazam (Onfi)
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 20, 2016)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02911025
Other Study ID Numbers 2014P001657
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pavlova, Milena,M.D., Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Milena Pavlova, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date October 2016