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

Restless Legs Syndrome Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label or Double-blind Treatment Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275457
• Other study ID #: 248.520
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2006
• Last updated: October 30, 2013
• Start date: October 2002
• Est. completion date: April 2004

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenNetherlands: Medical Ethics Review Committee (METC)Sweden: Medical Products AgencyNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• pramipexole

Locations

Country	Name	City	State
Austria	Univ.-Klinik für Neurologie	Graz
Austria	Univ.-Klinik für Neurologie	Innsbruck
Austria	AKH der Stadt Linz	Linz
Austria	AKH Universitätsklinik für Psychiatrie	Wien
Austria	Confraternität Privatklinik	Wien
Austria	Sonderkrankenanstalt für neurologischen und	Wien
Austria	Wilhelminenspital der Stadt Wien	Wien
Germany	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
Netherlands	Boehringer Ingelheim Investigational Site	Beek en Donk
Netherlands	Boehringer Ingelheim Investigational Site	Den Haag
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
Norway	Boehringer Ingelheim Investigational Site	Hamar
Norway	Boehringer Ingelheim Investigational Site	Oslo
Norway	Boehringer Ingelheim Investigational Site	Oslo
Norway	Boehringer Ingelheim Investigational Site	Tønsberg
Sweden	Boehringer Ingelheim Investigational Site	Göteborg
Sweden	Boehringer Ingelheim Investigational Site	Örebro
Sweden	Neurologkliniken	Stockholm
Sweden	Stockholms Neuro Center	Stockholm
Sweden	Boehringer Ingelheim Investigational Site	Uppsala
Sweden	Läkarhuset Vällingby	Vällingby
Sweden	Boehringer Ingelheim Investigational Site	Västra Frölunda

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline to week 6 on the RLSRS +
Primary	CGI-I responders (much and very much improved)
Secondary	RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS

External Links

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