Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

NCT00472199 | Completed Phase 4 Results

• 2 other identifiers: 248.629EUDRACT2006-006431-42
• Study Type: interventional
• Target: 331
• Locations: 9 countries
• Sites: 42

Brief Summary

The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo. The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks

  IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)

  Baseline and 26 weeks

Secondary Outcomes (30)

• Clinical Global Impression - Global Improvement (CGI-I) Responder Rate

  after 26 weeks of treatment

• International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate

  after 26 weeks of treatment

• Patient Global Impression (PGI) Responder Rate

  after 26 weeks of treatment

• Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks

  baseline and 26 weeks of treatment

• Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks

  Baseline and 26 weeks of treatment

Study Arms (2)

Pramipexole

EXPERIMENTAL

4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase or decrease the dose in steps to 0.25 mg, 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks.

Drug: Pramipexole

Placebo

PLACEBO COMPARATOR

4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks.

Drug: Placebo

Interventions

Pramipexole DRUG

Pramipexole

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local Institutional Review Board/Independent Ethics Committee (IRB/IEC) requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments
• Male or female out-patients aged 18-85 years
• Diagnosis of idiopathic RLS according to the clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG) \[P03-03355\]. All four criteria must be present to fulfil the diagnosis of RLS.
• RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2)
• IRLS total score \>15 at baseline (Visit 2)

You may not qualify if:

• Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner's surgical sterilization
• Any woman of child-bearing potential not having a negative pregnancy test at screening
• Breastfeeding women
• Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
• Diagnosis of augmentation under previous pharmacological RLS treatment
• Concomitant or previous pharmacologic therapy as follows: Any intake of dopamine agonists within 14 days prior to baseline (Visit 2); Any intake of levodopa within 14 days prior to baseline (Visit 2); Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole);

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (42)

248.629.4302 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

248.629.4304 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

248.629.3201 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

248.629.35801 Boehringer Ingelheim Investigational Site

Espoo, Finland

Location

248.629.35805 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

248.629.35804 Boehringer Ingelheim Investigational Site

Joensuu, Finland

Location

248.629.35802 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

248.629.35806 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

248.629.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

248.629.4908 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

248.629.4901 Boehringer Ingelheim Investigational Site

Ellwangen, Germany

Location

248.629.4904 Boehringer Ingelheim Investigational Site

Hellersdorf, Germany

Location

248.629.4906 Boehringer Ingelheim Investigational Site

Herborn, Germany

Location

248.629.4905 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

248.629.4909 Boehringer Ingelheim Investigational Site

Schwerin, Germany

Location

248.629.4903 Boehringer Ingelheim Investigational Site

Steglitz, Germany

Location

248.629.4907 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

248.629.35301 Boehringer Ingelheim Investigational Site

Carrigtohill, Ireland

Location

248.629.35302 Boehringer Ingelheim Investigational Site

Co. Kildare, Ireland

Location

248.629.35303 Boehringer Ingelheim Investigational Site

Co. Tipperary, Ireland

Location

248.629.31001 Boehringer Ingelheim Investigational Site

Bennebroek, Netherlands

Location

248.629.31005 Boehringer Ingelheim Investigational Site

Hoogwoud, Netherlands

Location

248.629.31006 Boehringer Ingelheim Investigational Site

Musselkanaal, Netherlands

Location

248.629.31002 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

248.629.31003 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

248.629.31004 Boehringer Ingelheim Investigational Site

Rijswijk, Netherlands

Location

248.629.4204 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

248.629.4205 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

248.629.4202 Boehringer Ingelheim Investigational Site

Brezno, Slovakia

Location

248.629.4201 Boehringer Ingelheim Investigational Site

Košice, Slovakia

Location

248.629.4203 Boehringer Ingelheim Investigational Site

Martin, Slovakia

Location

248.629.3402 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

248.629.3405 Boehringer Ingelheim Investigational Site

Granada, Spain

Location

248.629.3401 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

248.629.3403 Boehringer Ingelheim Investigational Site

San Sebastián, Spain

Location

248.629.3406 Hospital Arnau de Vilanova

Valencia, Spain

Location

248.629.44003 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

248.629.44006 Boehringer Ingelheim Investigational Site

Edgbaston, Birmingham, United Kingdom

Location

248.629.44004 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

248.629.44001 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

248.629.44002 Boehringer Ingelheim Investigational Site

Reading, United Kingdom

Location

248.629.44005 Boehringer Ingelheim Investigational Site

Waterloo, Liverpool, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2008
• Last Updated: June 27, 2014
• Results First Posted: November 17, 2009

Record last verified: 2012-05

Locations

BE (1); SL (5); GB (6); AU (2); FI (5); DE (9); IE (3); NL (6); ES (5)