Full Text View
Tabular View
No Study Results Posted
Related Studies
A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)
This study has been completed.
First Received: October 28, 2005   No Changes Posted
Sponsors and Collaborators: Sleep Health Centers
UCB
Information provided by: Sleep Health Centers
ClinicalTrials.gov Identifier: NCT00247364
  Purpose

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 Intervention Phase
Restless Legs Syndrome
Drug: Levetiracetam (Keppra)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)

Resource links provided by NLM:


Further study details as provided by Sleep Health Centers:

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

Estimated Enrollment: 20
Study Start Date: November 2003
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247364

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

No publications provided

Study ID Numbers: 2003-P-001804
Study First Received: October 28, 2005
Last Updated: October 28, 2005
ClinicalTrials.gov Identifier: NCT00247364     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Sleep Health Centers:
RLS

Study placed in the following topic categories:
Nootropic Agents
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Neuroprotective Agents
Dyskinesias
Sleep Disorders, Intrinsic
Signs and Symptoms
Mental Disorders
Restless Legs Syndrome
Neurologic Manifestations
Piracetam
Etiracetam
Neurobehavioral Manifestations
Anticonvulsants

Additional relevant MeSH terms:
Physiological Effects of Drugs
Sleep Disorders
Psychomotor Agitation
Neuroprotective Agents
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome
Therapeutic Uses
Restless Legs Syndrome
Psychomotor Disorders
Neurobehavioral Manifestations
Nootropic Agents
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Dyskinesias
Protective Agents
Pharmacologic Actions
Neurologic Manifestations
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 10, 2009