Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients

NCT00275457 | Completed Phase 3

• 1 other identifier: 248.520
• Study Type: interventional
• Target: 346
• Locations: 5 countries
• Sites: 34

Brief Summary

To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline to week 6 on the RLSRS +

• CGI-I responders (much and very much improved)

Secondary Outcomes (1)

• RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS

Interventions

pramipexole DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female out-patients aged 18-80
• Diagnosis of idiopathic RLS according to the Clinical RLS criteria of the International RLS Study Group. All of the four criteria must be present:
• Irresistible urge to move usually associated with sensory complaints of the lower limbs
• Motor restlessness
• Worsening of the symptoms at rest with at least partial and temporary relief by activity
• Increased severity in the evening or at night
• RLS rating scale for severity score \> 15
• RLS symptoms present at least 2 to 3 days per week within in the last 3 months
• Written informed consent consistent with ICH/GCP and local legislation given prior to any study procedures
• Ability and willingness to comply with study treatment regimen and to attend study assessments

You may not qualify if:

• Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception or postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection or women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom, or any women not having negative serum pregnancy test at screening
• Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation)
• Patients who are breastfeeding
• Concomitant or previous pharmacologically therapy of RLS as follows:
• Any intake of levodopa within 5 days prior to baseline visit (V2)
• Any intake of dopamine agonists within 14 days prior to baseline visit (V2)
• History of any intake of pramipexole
• Current (less than 14 days before treatment with trial medication or concomitant) treatment with medication or dietary supplements, which could significantly influence RLS symptoms - withdrawal symptoms caused by stopping any of the drugs above
• Confirmed diagnose of diabetes mellitus requiring insulin therapy
• Clinically significant renal disease or creatinine higher than upper limit of normal (ULN) at screening
• Clinically significant hepatic disease or sGPT \> 2 times the upper limit of normal range at screening
• Clinical or laboratory signs of microcytic anaemia at the investigators discretion
• Any of the following lab results at screening:
• Hb or erythrocyte count below lower limit of normal (LLN)
• Basal TSH, T3 or T4 clinically significantly (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (34)

Univ.-Klinik für Neurologie

Graz, 8036, Austria

Location

Univ.-Klinik für Neurologie

Innsbruck, 6020, Austria

Location

AKH der Stadt Linz

Linz, 4021, Austria

Location

Confraternität Privatklinik

Vienna, 1080, Austria

Location

AKH Universitätsklinik für Psychiatrie

Vienna, 1090, Austria

Location

Sonderkrankenanstalt für neurologischen und

Vienna, 1130, Austria

Location

Wilhelminenspital der Stadt Wien

Vienna, 1160, Austria

Location

Boehringer Ingelheim Investigational Site

Bad Dürrheim-Sunthausen, 78073, Germany

Location

Boehringer Ingelheim Investigational Site

Bad Krozingen, 79189, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 10625, Germany

Location

emovis GmbH

Berlin, 10629, Germany

Location

Facharzt für Neurologie

Emmendingen, 79312, Germany

Location

Boehringer Ingelheim Investigational Site

Kehl, 77694, Germany

Location

ClinPharm International GmbH & Co. KG

Leipzig, 04229, Germany

Location

Universitätsklinikum Giessen und Marburg

Marburg, 35039, Germany

Location

Boehringer Ingelheim Investigational Site

Beek en Donk, 5741 AR, Netherlands

Location

Boehringer Ingelheim Investigational Site

Deurne, 5751 XJ, Netherlands

Location

Boehringer Ingelheim Investigational Site

Ewijk, 6644 CL, Netherlands

Location

Boehringer Ingelheim Investigational Site

Lichtenvoorde, 7131 CM, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rijswijk, 2281 AK, Netherlands

Location

Boehringer Ingelheim Investigational Site

Roelofarendsveen, 2371 RB, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rotterdam, 3082 DC, Netherlands

Location

Boehringer Ingelheim Investigational Site

The Hague, 2585 LJ, Netherlands

Location

Boehringer Ingelheim Investigational Site

Hamar, N-2317, Norway

Location

Boehringer Ingelheim Investigational Site

Oslo, N-0159, Norway

Location

Boehringer Ingelheim Investigational Site

Oslo, N-0303, Norway

Location

Boehringer Ingelheim Investigational Site

Tønsberg, N-3111, Norway

Location

Boehringer Ingelheim Investigational Site

Gothenburg, 413 45, Sweden

Location

Boehringer Ingelheim Investigational Site

Örebro, 701 85, Sweden

Location

Stockholms Neuro Center

Stockholm, 112 81, Sweden

Location

Neurologkliniken

Stockholm, 141 86, Sweden

Location

Boehringer Ingelheim Investigational Site

Uppsala, 751 85, Sweden

Location

Läkarhuset Vällingby

Vällingby, 162 68, Sweden

Location

Boehringer Ingelheim Investigational Site

Västra Frölunda, 421 30, Sweden

Location

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

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Pharma GmbH & Co. KG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 12, 2006
• Study Start: October 1, 2002
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

NL (8); NO (4); AU (7); DE (8); SE (7)