Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00991276

Purpose

The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: pregabalin Drug: placebo Drug: pramipexole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Restless Legs Sleep Disorders

Drug Information available for: Pramipexol Pregabalin Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Comparison of Wake After Sleep Onset (WASO) as measured by polysomnography at the end of each treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of Periodic Limb Movement Arousal Index (PLMAI) as measured by polysomnography at the end of each treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Comparison of Subjective Total Sleep Time (sTST) at the end of each treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Assessment of sleep related efficacy measures, patient reported outcomes, and safety and tolerability. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	85
Study Start Date:	December 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: pregabalin	Drug: pregabalin capsules; 300 mg once-per-day; 4 weeks of treatment Other Name: Lyrica
Placebo Comparator: placebo	Drug: placebo capsules; 0 mg once-per-day; 4 weeks of treatment
Active Comparator: pramipexole	Drug: pramipexole capsules; 0.5 mg once-per-day; 4 weeks of treatment Other Name: Mirapex

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS).
RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months.
PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs.

Exclusion Criteria:

Secondary RLS.
Daytime RLS symptoms requiring treatment.
Primary sleep disorder.
Sleep apnea.
Night or shift work.
Concurrent medical disorder that could interfere with efficacy assessment or present a safety concern.
Pregnant or lactating women.
Women of child-bearing potential not using acceptable method of birth control.
Use of prohibited medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991276

Show 42 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00991276 History of Changes
Other Study ID Numbers:	A0081185
Study First Received:	October 6, 2009
Last Updated:	July 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

restless legs syndrome RLS polysomnography PSG sleep disturbance patient reported outcome

Additional relevant MeSH terms:

Restless Legs Syndrome
Sleep Disorders
Dyssomnias
Parasomnias
Psychomotor Agitation
Sleep Disorders, Intrinsic
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Dyskinesias
Psychomotor Disorders
Neurobehavioral Manifestations
Pramipexol
Pregabalin

Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012