Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

NCT00806026 | Completed Phase 3 Results DMC

• 1 other identifier: A0081186
• Study Type: interventional
• Target: 731
• Locations: 9 countries
• Sites: 110

Brief Summary

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Conditions

Idiopathic Restless Legs Syndrome

Keywords

RLS

Outcome Measures

Primary Outcomes (4)

• Restless Legs Syndrome (RLS) Symptom Severity

  International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.

  Baseline

• Change From Baseline in the RLS Symptom Severity at Week 12

  IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.

  Baseline, Week 12

• Percentage of Participants Responding to Treatment at Week 12

  CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of "very much improved" or "much improved".

  Week 12

• Percentage of Participants With Augmentation

  Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.

  Baseline up to Week 52

Secondary Outcomes (18)

• Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)

  Baseline

• Change From Baseline in SSQ: Subjective WASO at Week 12

  Baseline, Week 12

• Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12

  Week 12

• Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12

  Week 12

• Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12

  Week 12

Study Arms (6)

PBO/PGB 300 mg

EXPERIMENTAL

Drug: placebo and pregabalin

PBO/PPX 0.25 mg

ACTIVE COMPARATOR

Drug: pramipexol

PBO/PPX 0.5 mg

ACTIVE COMPARATOR

Drug: pramipexol

PGB 300 mg

EXPERIMENTAL

Drug: Pregabalin

PPX 0.25 mg

ACTIVE COMPARATOR

Drug: pramipexol

PPX 0.5 mg

ACTIVE COMPARATOR

Drug: pramipexol

Interventions

placebo and pregabalin DRUG

following 3 months placebo treatment, subjects are to be re-distributed to pregabalin 300 mg per day for 9 months. Both placebo and pregabalin are to be administered orally once a day, 1-3 hours before bedtime.

Also known as: Lyrica

PBO/PGB 300 mg

pramipexol DRUG

following 3 months placebo treatment, subjects are to be re-distributed to pramipexol 0.25mg per day for 9 months. Both placebo and pramipexol are to be administered orally once a day, 1-3 hours before bedtime.

Also known as: Mirapex

PBO/PPX 0.25 mg

Pregabalin DRUG

pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 months

Also known as: Lyrica

PGB 300 mg

Eligibility Criteria

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

You may qualify if:

• idiopathic RLS with the presence of all four clinical manifestations of RLS
• RLS symptoms occur predominantly in the evening
• RLS history at least 6 months
• IRLS =\> 15 at the beginning and the end of placebo run-in
• Have =\>15 nights with RLS symptoms in the month prior to screening

You may not qualify if:

• Any secondary RLS
• Current augmentation due to RLS treatment
• Placebo responders identified during the placebo run-in

Sponsors & Collaborators

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

Study Sites (110)

Pfizer Investigational Site

Birmingham, Alabama, 35209, United States

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Jasper, Alabama, 35501, United States

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Tuscaloosa, Alabama, 35406, United States

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Glendale, Arizona, 85308, United States

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Phoenix, Arizona, 85032, United States

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Phoenix, Arizona, 85050, United States

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Little Rock, Arkansas, 72205, United States

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Little Rock, Arkansas, 72211, United States

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Northridge, California, 91325, United States

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Redondo Beach, California, 90277, United States

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San Diego, California, 92103, United States

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San Diego, California, 92121, United States

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Santa Monica, California, 90404, United States

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Torrance, California, 90502, United States

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Aurora, Colorado, 80012, United States

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Boca Raton, Florida, 33486, United States

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Hallandale, Florida, 33009, United States

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Miami, Florida, 33143, United States

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Pembroke Pines, Florida, 33026, United States

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South Miami, Florida, 33143, United States

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Atlanta, Georgia, 30342, United States

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Overland Park, Kansas, 66212, United States

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Louisville, Kentucky, 40217, United States

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Baton Rouge, Louisiana, 70808, United States

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Chevy Chase, Maryland, 20815, United States

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Newton, Massachusetts, 02459, United States

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Southfield, Michigan, 48034, United States

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Minneapolis, Minnesota, 55415, United States

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Princeton, New Jersey, 08540, United States

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New York, New York, 10019, United States

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Salisbury, North Carolina, 28144-0000, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43210, United States

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Oklahoma City, Oklahoma, 73112, United States

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Lafayette Hill, Pennsylvania, 19444, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77063, United States

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Plano, Texas, 75093, United States

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Walla Walla, Washington, 99362, United States

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Innsbruck, A-6020, Austria

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Linz, A-4021, Austria

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Vienna, 1090, Austria

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Helsinki, 00420, Finland

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Kuopio, 70210, Finland

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Tampere, 33520, Finland

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Turku, 20520, Finland

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Achim, 28832, Germany

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Bad Saarow, 15526, Germany

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Berlin, 10117, Germany

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Berlin, 10245, Germany

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Berlin, 10365, Germany

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Berlin, 10437, Germany

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Berlin, 10629, Germany

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Berlin, 10969, Germany

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Berlin, 12163, Germany

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Berlin, 12683, Germany

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Berlin, 13156, Germany

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Bochum, 44787, Germany

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Bochum, 44805, Germany

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Bremen, 28325, Germany

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Dortmund, 44229, Germany

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Dresden, 01307, Germany

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Freiburg im Breisgau, 79106, Germany

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Gelsenkirchen, 45879, Germany

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Halle, 06118, Germany

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Hamm, 59065, Germany

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Jena, 07743, Germany

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Jülich, 52428, Germany

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Kassel, 34128, Germany

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Kassel, 34131, Germany

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Köthen, 06366, Germany

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Leipzig, 04107, Germany

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Marburg, 35039, Germany

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München, 80331, Germany

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Oldenburg, 26122, Germany

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Prien am Chiemsee, 83209, Germany

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Schwerin, 19053, Germany

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Siegen, 57072, Germany

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Ulm, 89073, Germany

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Ulm, 89081, Germany

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Unterhaching, 82008, Germany

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Westerstede, 26655, Germany

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Würzburg, 97070, Germany

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Pavia, 27100, Italy

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Pisa, 56126, Italy

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Rome, 00163, Italy

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Rome, 00185, Italy

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Troina, 94018, Italy

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Troina(EN), 94018, Italy

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Ede, 6716 RP, Netherlands

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Zwolle, 8025 BV, Netherlands

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Barcelona, Cataluña/Spain, 08003, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Granada, 18014, Spain

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Madrid, 28036, Spain

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Avesta, 77482, Sweden

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Avesta, SE-774 82, Sweden

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Gothenburg, 40530, Sweden

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Gothenburg, 413 45, Sweden

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Örebro, 701 85, Sweden

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Örebro, 70185, Sweden

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Skövde, 541 85, Sweden

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Skövde, 54185, Sweden

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Skövde, SE-541 85, Sweden

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Stockholm, 11245, Sweden

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Reading Berks, RG2 0TG, United Kingdom

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Related Publications (1)

• Allen RP, Chen C, Garcia-Borreguero D, Polo O, DuBrava S, Miceli J, Knapp L, Winkelman JW. Comparison of pregabalin with pramipexole for restless legs syndrome. N Engl J Med. 2014 Feb 13;370(7):621-31. doi: 10.1056/NEJMoa1303646.

  PMID: 24521108 DERIVED

Related Links

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

MeSH Terms

Interventions

Pregabalin; Pramipexole

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

Limitations and Caveats

Names of Daytime Function-Participant Reported Outcome (DF-PRO) and Limb Pain-Numerical Rating Scale (Limb Pain-NRS) were updated to RLS-NDI and Limb Pain-VAS respectively to reflect measurement appropriately.

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 26, 2021
• Results First Posted: September 27, 2012

Record last verified: 2012-08

Locations

FI (4); GB (1); AU (3); NL (2); ES (5); DE (37); IT (6); SE (10); US (42)