Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome
This study has been withdrawn prior to enrollment.
(Study withdrawn due to budget (personnel) limitations.)
Sponsor:
University of South Florida
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00584246
First received: December 21, 2007
Last updated: June 2, 2008
Last verified: June 2008
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Purpose
This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Restless Legs Syndrome |
Drug: Pregabalin (Lyrica) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome |
Resource links provided by NLM:
MedlinePlus related topics:
Restless Legs
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- International RLS Study Group Severity Scale (IRLS) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical Global Impression (CGI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 22 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Pregabalin (Lyrica)
|
Drug: Pregabalin (Lyrica)
50 - 150 mg po qhs for 2 months
|
|
Placebo Comparator: 2
Placebo
|
Drug: Pregabalin (Lyrica)
50 - 150 mg po qhs for 2 months
Drug: Placebo
50 - 150 mg po qhs for 2 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist .
- Patients must report some degree of pain which occurs on a regular basis.
- Age 18 years to 80 years.
- Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
- Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
- Willing and able to provide informed consent.
- Willing to comply with protocol. -
Exclusion Criteria:
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline).
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- Legal incapacity or limited legal capacity.
- Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP.
- Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34).
- Presence of severe daytime sleepiness.
- Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
- Patients taking dopamine agonists for any condition other than RLS. -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584246
Locations
| United States, Florida | |
| University of South Florida | |
| Tampa, Florida, United States, 33612 | |
Sponsors and Collaborators
University of South Florida
Investigators
| Principal Investigator: | Theresa A Zesiewicz, MD | University of South Florida |
More Information
No publications provided
| Responsible Party: | Theresa Zesiewicz, MD, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00584246 History of Changes |
| Other Study ID Numbers: | 3, 105362 |
| Study First Received: | December 21, 2007 |
| Last Updated: | June 2, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
Restless legs syndrome RLS Pregabalin Lyrica |
Additional relevant MeSH terms:
|
Restless Legs Syndrome Psychomotor Agitation Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Parasomnias Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders |
Neurobehavioral Manifestations Signs and Symptoms Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013