NCT00676403

Brief Summary

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
4 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 4, 2010

Completed
Last Updated

February 10, 2021

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

May 8, 2008

Results QC Date

January 8, 2010

Last Update Submit

January 21, 2021

Conditions

Restless Legs Syndrome

Keywords

pregabalin, RLS, efficacy, safety

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6

    IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.

    Baseline, Week 6

Secondary Outcomes (19)

  • Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)

    Week 6

  • Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)

    Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)

  • Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline

    Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

  • Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline

    Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

  • Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline

    Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6

  • +14 more secondary outcomes

Study Arms (6)

1

PLACEBO COMPARATOR

Placebo

Drug: placebo

2

EXPERIMENTAL

investigational treatment

Drug: Pregabalin

3

EXPERIMENTAL

investigational treatment

Drug: Pregabalin

4

EXPERIMENTAL

investigational treatment

Drug: Pregabalin

5

EXPERIMENTAL

investigational treatment

Drug: Pregabalin

6

EXPERIMENTAL

investigational treatment

Drug: Pregabalin

Interventions

placeboDRUG

Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks

Also known as: Sugar pill
1
PregabalinDRUG

50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

Also known as: Lyrica, PD 0144723; CI-1008
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe idiopathic RLS
  • symptoms occur predominantly in the evening
  • symptoms interfere with sleep onset or maintenance

You may not qualify if:

  • Any secondary RLS
  • require treatment for daytime RLS symptoms
  • symptomatic neuropathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Pfizer Investigational Site

Tuscaloosa, Alabama, 35406, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

San Diego, California, 92121, 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

Brandon, Florida, 33511, United States

Location

Pfizer Investigational Site

Macon, Georgia, 31201, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

Location

Pfizer Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27607, United States

Location

Pfizer Investigational Site

Salisbury, North Carolina, 28144, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Alexandria, Virginia, 22311, United States

Location

Pfizer Investigational Site

Innsbruck, A-6020, Austria

Location

Pfizer Investigational Site

Vienna, A-1080, Austria

Location

Pfizer Investigational Site

Bad Saarow, 15526, Germany

Location

Pfizer Investigational Site

Berlin, 10969, Germany

Location

Pfizer Investigational Site

Göttingen, 37075, Germany

Location

Pfizer Investigational Site

Mittweida, 09648, Germany

Location

Pfizer Investigational Site

München, 80331, Germany

Location

Pfizer Investigational Site

Oldenburg, 26122, Germany

Location

Pfizer Investigational Site

Schwerin, 19053, Germany

Location

Pfizer Investigational Site

Madrid, 28036, Spain

Location

Related Publications (1)

  • Allen R, Chen C, Soaita A, Wohlberg C, Knapp L, Peterson BT, Garcia-Borreguero D, Miceli J. A randomized, double-blind, 6-week, dose-ranging study of pregabalin in patients with restless legs syndrome. Sleep Med. 2010 Jun;11(6):512-9. doi: 10.1016/j.sleep.2010.03.003. Epub 2010 May 13.

    PMID: 20466589DERIVED

Related Links

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

SugarsPregabalin

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

Carbohydratesgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 10, 2021

Results First Posted

February 4, 2010

Record last verified: 2010-06

Locations

DE(7)ES(1)US(15)AU(2)