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A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

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ClinicalTrials.gov Identifier: NCT00247364
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : November 1, 2005
UCB Pharma
Information provided by:
Sleep Health Centers

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Levetiracetam (Keppra) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)
Study Start Date : November 2003
Estimated Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Primary Outcome Measures :
  1. 1:To investigate the efficacy of levetiracetam when used to treat RLS.
  2. 2:To assess tolerability and adverse event rates.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with idiopathic RLS according to the four IRLSSG diagnostic criteria

    1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
    2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as sitting or lying down.
    3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
    4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.

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:

  1. Women of childbearing potential, who have a positive urine pregnancy test or are lactating as the screening visit, or do not practice a clinically accepted method of contraception.
  2. Individuals who are taking medication for Restless Legs Syndrome without a proper washout period
  3. Individuals who are taking hypnotics, sedatives, antipsychotics, or neuroleptics
  4. History of current diagnosis of other clinically relevant diseases that may confound assessments of RLS symptoms (e.g., Parkinson’s disease, dementia, ALS, etc.)
  5. Subjects with serum ferritin below 10µg/L
  6. Subjects with an untreated sleep disorder that may confound assessments (e.g., narcolepsy, sleep apnea syndrome or other breathing-related sleep disorders, or REM sleep behaviour disorder)
  7. Subjects with an apnea/hypopnea index of 15 or greater at the initial polysomnography visit
  8. Subjects employed in shift work (e.g., employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts)
  9. Subjects who have clinically significant or unstable medical conditions which in the opinion of the investigator would render the subject unsuitable for the study (e.g. severe cardiovascular disease, major depression, psychosis, hepatic or renal failure, etc.)
  10. subjects with a positive urine drug test for illicit use of amphetamines, barbiturates, benzodiazepines, opiates, synthetic narcotics, and miscellaneous drugs commonly known as recreational drugs (e.g., cannabinoids including THC, heroine, cocaine)
  11. Participation in any clinical drug or device trial in the 30 days prior to the screening visit.

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): NCT00247364

United States, Massachusetts
Sleep Health Centers
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
Sleep Health Centers
UCB Pharma
Principal Investigator: John W Winkelman, MD, PhD Sleep Health Centers, Brigham and Women's Hosptial

ClinicalTrials.gov Identifier: NCT00247364     History of Changes
Other Study ID Numbers: 2003-P-001804
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: November 1, 2005
Last Verified: October 2005

Keywords provided by Sleep Health Centers:

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs