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

NCT ID: NCT00275457

Last Updated: 2013-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2004-04-30

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.

Detailed Description

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 weeks open label or double blind extension

Study Hypotheses:

Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment.

Comparison(s):

Pramipexole vs. Placebo

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

pramipexole

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female out-patients aged 18-80

2. 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

3. RLS rating scale for severity score > 15

4. RLS symptoms present at least 2 to 3 days per week within in the last 3 months

5. Written informed consent consistent with ICH/GCP and local legislation given prior to any study procedures

6. Ability and willingness to comply with study treatment regimen and to attend study assessments

Exclusion Criteria

1. 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

2. Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation)

3. Patients who are breastfeeding

4. 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

5. 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

6. Confirmed diagnose of diabetes mellitus requiring insulin therapy

7. Clinically significant renal disease or creatinine higher than upper limit of normal (ULN) at screening

8. Clinically significant hepatic disease or sGPT > 2 times the upper limit of normal range at screening

9. Clinical or laboratory signs of microcytic anaemia at the investigators discretion

10. 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)

11. Other clinically significant metabolic-endocrine, haematological, gastro-intestinal disease or pulmonary disease. Poorly controlled cardiovascular disease

12. History or clinical signs of peripheral neuropathy (PNP) of any origin in physical, neurological examination, myelopathy or multiple sclerosis or any other neurological disease, with potential to secondarily cause RLS symptoms

13. Presence of any other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnoea syndrome

14. History of Schizophrenia or any psychotic disorder, history of mental disorders due to a general medical condition or any present axis I psychiatric disorder according DSM IV requiring any medical therapy or history of or alcohol abuse or drug addiction within the last 2 years before screening

15. Participation in a drug study within two months prior to the start of this study

16. History of or clinical signs for any form of epilepsy or seizures apart from fever related seizures in early childhood

17. History of or clinical signs of malign neoplasm

18. Patients on a shift-work-schedule, or who are otherwise unable to follow a regular sleep-wake cycle enabling use of study medication at times indicated

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Pharma GmbH & Co. KG

Locations

Univ.-Klinik für Neurologie

Graz, , Austria

Univ.-Klinik für Neurologie

Innsbruck, , Austria

AKH der Stadt Linz

Linz, , Austria

Confraternität Privatklinik

Vienna, , Austria

AKH Universitätsklinik für Psychiatrie

Vienna, , Austria

Sonderkrankenanstalt für neurologischen und

Vienna, , Austria

Wilhelminenspital der Stadt Wien

Vienna, , Austria

Boehringer Ingelheim Investigational Site

Bad Dürrheim-Sunthausen, , Germany

Boehringer Ingelheim Investigational Site

Bad Krozingen, , Germany

Boehringer Ingelheim Investigational Site

Berlin, , Germany

emovis GmbH

Berlin, , Germany

Facharzt für Neurologie

Emmendingen, , Germany

Boehringer Ingelheim Investigational Site

Kehl, , Germany

ClinPharm International GmbH & Co. KG

Leipzig, , Germany

Universitätsklinikum Giessen und Marburg

Marburg, , Germany

Boehringer Ingelheim Investigational Site

Beek en Donk, , Netherlands

Boehringer Ingelheim Investigational Site

Deurne, , Netherlands

Boehringer Ingelheim Investigational Site

Ewijk, , Netherlands

Boehringer Ingelheim Investigational Site

Lichtenvoorde, , Netherlands

Boehringer Ingelheim Investigational Site

Rijswijk, , Netherlands

Boehringer Ingelheim Investigational Site

Roelofarendsveen, , Netherlands

Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

Boehringer Ingelheim Investigational Site

The Hague, , Netherlands

Boehringer Ingelheim Investigational Site

Hamar, , Norway

Boehringer Ingelheim Investigational Site

Oslo, , Norway

Boehringer Ingelheim Investigational Site

Oslo, , Norway

Boehringer Ingelheim Investigational Site

Tønsberg, , Norway

Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Boehringer Ingelheim Investigational Site

Örebro, , Sweden

Stockholms Neuro Center

Stockholm, , Sweden

Neurologkliniken

Stockholm, , Sweden

Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Läkarhuset Vällingby

Vällingby, , Sweden

Boehringer Ingelheim Investigational Site

Västra Frölunda, , Sweden

Countries

Austria; Germany; Netherlands; Norway; Sweden

Other Identifiers

248.520

Identifier Type: -

Identifier Source: org_study_id