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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 : Completed
First Posted : September 22, 2016
Results First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pavlova, Milena,M.D., Brigham and Women's Hospital

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

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
Study Start Date : January 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Clobazam

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam [ Time Frame: 1 week after reaching effective clobazam dose ]
    The change in total sleep time in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose


Secondary Outcome Measures :
  1. Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam [ Time Frame: 1 week after reaching effective clobazam dose ]
    The change in wake after sleep onset (WASO) in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with Epilepsy who have recently been started on Clobazam (Onfi)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911025


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Faulkner Hospital
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Milena Pavlova, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Pavlova, Milena,M.D., Brigham and Women's Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] October 19, 2020

More Information
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Responsible Party: Pavlova, Milena,M.D., Assistant Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02911025    
Other Study ID Numbers: 2014P001657
First Posted: September 22, 2016    Key Record Dates
Results First Posted: February 8, 2021
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pavlova, Milena,M.D., Brigham and Women's Hospital:
epilepsy
sleep
antiepileptic drugs
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases