Clinical trial NCT00991276: Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: restless legs syndrome RLS polysomnography PSG sleep disturbance patient reported outcome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Wake After Sleep Onset (WASO)
timeFrame: 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:
measure: Periodic Limb Movement Arousal Index (PLMAI)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Subjective Total Sleep Time (sTST)
timeFrame: Week 3 and Week 5 of Each Intervention Period or ET
measure: Minutes of Stage N1, N2, N3 and R Sleep
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Restless Legs Syndrome-Next Day Impact (RLS-NDI)
timeFrame: Week 3 and Week 5 of Each Intervention Period or ET
measure: Periodic Limb Movement Index (PLMI)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Periodic Limb Movement in Sleep Index (PLMSI)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Number of Arousals (NASO)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Arousal Index (NASOI)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: International Restless Legs Syndrome Study Group Rating Scale (IRLS)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale
timeFrame: Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Latency to Stage R Sleep (LREM)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Latency to Persistent Sleep (LPS)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Wake Time During Sleep (WTDS)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Wake Time After Sleep (WTAS)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Total Sleep Time (TST)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Sleep Efficiency (SE)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Hourly and Quarterly Assessment of Number of Arousals (NASO)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Hourly and Quarterly Assessment of Sleep Efficiency (SE)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale
timeFrame: Week 3 and Week 5 of Each Intervention Period or ET
measure: Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale
timeFrame: Week 3 and Week 5 of each intervention period or ET
measure: Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale
timeFrame: Week 3 and Week 5 of each intervention period or ET
measure: Subjective Sleep Questionnaire (SSQ): Latency Subscale
timeFrame: Week 3 and Week 5 of each intervention period or ET
measure: Medical Outcomes Study - Sleep Scale (MOS-SS)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
measure: Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)
timeFrame: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Burlingame
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Redlands
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hallandale Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Spring Hill
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Macon
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Brighton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Portage
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dublin
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Clarks Summit
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lafayette Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.