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The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Adults with Epilepsy who have recently been started on Clobazam (Onfi)
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| Name | Affiliation | Role |
|---|---|---|
| Milena Pavlova, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Brigham and Women's Faulkner Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | minutes | 1 week after reaching effective clobazam dose |
|
|
Each patient was followed for one week during the treatment phase.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation Side Effect | Product Issues | Non-systematic Assessment | Patient felt sedation when taking this medication and did not enjoy it. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Milena Pavlova | Brigham and Women's Hospital | 6174772129 | mpavlova@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Feb 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Jamaica Plain |
| Massachusetts |
| 02130 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Mean | Standard Deviation | count of awakenings | 1 week after reaching effective clobazam dose |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 1 |
| 13 |
|
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