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

NCT00991276 | Completed Phase 3 Results

• 1 other identifier: A0081185
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 41

Brief Summary

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.

Conditions

Restless Legs Syndrome

Keywords

restless legs syndrome RLS polysomnography PSG sleep disturbance patient reported outcome

Outcome Measures

Primary Outcomes (1)

• Wake After Sleep Onset (WASO)

  WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep \[WTDS\] epochs + Wake Time After Sleep \[WTAS\] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.

  Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)

Secondary Outcomes (30)

• Periodic Limb Movement Arousal Index (PLMAI)

  Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

• Subjective Total Sleep Time (sTST)

  Week 3 and Week 5 of Each Intervention Period or ET

• Minutes of Stage N1, N2, N3 and R Sleep

  Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

• Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)

  Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET

• Restless Legs Syndrome-Next Day Impact (RLS-NDI)

  Week 3 and Week 5 of Each Intervention Period or ET

Study Arms (3)

pregabalin

EXPERIMENTAL

Drug: pregabalin

placebo

PLACEBO COMPARATOR

Drug: placebo

pramipexole

ACTIVE COMPARATOR

Drug: pramipexole

Interventions

pregabalin DRUG

capsules; 300 mg once-per-day; 4 weeks of treatment

Also known as: Lyrica

pregabalin

placebo DRUG

capsules; 0 mg once-per-day; 4 weeks of treatment

placebo

pramipexole DRUG

capsules; 0.5 mg once-per-day; 4 weeks of treatment

Also known as: Mirapex

pramipexole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (41)

Pfizer Investigational Site

Jasper, Alabama, 35501, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85037, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Pfizer Investigational Site

Burlingame, California, 94010, United States

Location

Pfizer Investigational Site

Pasadena, California, 91106, United States

Location

Pfizer Investigational Site

Redlands, California, 92373, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

San Diego, California, 92121, United States

Location

Pfizer Investigational Site

Santa Ana, California, 92705, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80012, United States

Location

Pfizer Investigational Site

Hallandale, Florida, 33009, United States

Location

Pfizer Investigational Site

Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Pembroke Pines, Florida, 33026, United States

Location

Pfizer Investigational Site

Spring Hill, Florida, 34609, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Macon, Georgia, 31201, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Pfizer Investigational Site

Crestview Hills, Kentucky, 41017, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40513, United States

Location

Pfizer Investigational Site

Baton Rouge, Louisiana, 70809, United States

Location

Pfizer Investigational Site

Chevy Chase, Maryland, 20815, United States

Location

Pfizer Investigational Site

Brighton, Massachusetts, 02135, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49048, United States

Location

Pfizer Investigational Site

Portage, Michigan, 49024, United States

Location

Pfizer Investigational Site

New York, New York, 10019, United States

Location

Pfizer Investigational Site

Hickory, North Carolina, 28601, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27607, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45227, United States

Location

Pfizer Investigational Site

Dublin, Ohio, 43017, United States

Location

Pfizer Investigational Site

Middleburg Heights, Ohio, 44130, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Pfizer Investigational Site

Clarks Summit, Pennsylvania, 18411, United States

Location

Pfizer Investigational Site

Lafayette Hill, Pennsylvania, 19444, United States

Location

Pfizer Investigational Site

Columbia, South Carolina, 29201, United States

Location

Pfizer Investigational Site

Austin, Texas, 78731, United States

Location

Pfizer Investigational Site

Austin, Texas, 78756, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Related Publications (1)

• Garcia-Borreguero D, Patrick J, DuBrava S, Becker PM, Lankford A, Chen C, Miceli J, Knapp L, Allen RP. Pregabalin versus pramipexole: effects on sleep disturbance in restless legs syndrome. Sleep. 2014 Apr 1;37(4):635-43. doi: 10.5665/sleep.3558.

  PMID: 24899755 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pregabalin; Pramipexole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 15, 2021
• Results First Posted: October 8, 2012

Record last verified: 2012-09

Locations

US (41)