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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
To define the effective dose and tolerability of levetiracetam in individuals with Restless Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and effective in treating the symptoms of RLS.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam (Keppra) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 1:To investigate the efficacy of levetiracetam when used to treat RLS. | ||
| 2:To assess tolerability and adverse event rates. |
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Inclusion Criteria:
Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria
IRLS Rating Scale score greater than 15 at Baseline visit PLM-Index of 5 or greater during the first night of polysomnography Written informed consent obtained prior to any study procedures being performed.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Winkelman, MD, PhD | Sleep Health Centers, Brigham and Women's Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Health Centers | Newton | Massachusetts | 02459 | United States |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |