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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00275457
• Collaborator: (none)
• Enrollment: 346
• Locations: 34
• Duration (Months): 18
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: pramipexole	Phase 3

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2002
• Actual Primary Completion Date: Apr 1, 2004
• Study Completion Date: Apr 1, 2004

Outcome Measures

Primary Outcome Measures

1. Mean change from baseline to week 6 on the RLSRS + []

2. CGI-I responders (much and very much improved) []

Secondary Outcome Measures

1. RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. RLS rating scale for severity score > 15

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

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

4. 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

1. 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

2. Confirmed diagnose of diabetes mellitus requiring insulin therapy

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

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

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

6. 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)

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

2. 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

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

4. 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

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

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

7. History of or clinical signs of malign neoplasm

8. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ.-Klinik für Neurologie	Graz		Austria	8036
2	Univ.-Klinik für Neurologie	Innsbruck		Austria	6020
3	AKH der Stadt Linz	Linz		Austria	4021
4	Confraternität Privatklinik	Wien		Austria	1080
5	AKH Universitätsklinik für Psychiatrie	Wien		Austria	1090
6	Sonderkrankenanstalt für neurologischen und	Wien		Austria	1130
7	Wilhelminenspital der Stadt Wien	Wien		Austria	1160
8	Boehringer Ingelheim Investigational Site	Bad Dürrheim-Sunthausen		Germany	78073
9	Boehringer Ingelheim Investigational Site	Bad Krozingen		Germany	79189
10	Boehringer Ingelheim Investigational Site	Berlin		Germany	10625
11	emovis GmbH	Berlin		Germany	10629
12	Facharzt für Neurologie	Emmendingen		Germany	79312
13	Boehringer Ingelheim Investigational Site	Kehl		Germany	77694
14	ClinPharm International GmbH & Co. KG	Leipzig		Germany	04229
15	Universitätsklinikum Giessen und Marburg	Marburg		Germany	35039
16	Boehringer Ingelheim Investigational Site	Beek en Donk		Netherlands	5741 AR
17	Boehringer Ingelheim Investigational Site	Den Haag		Netherlands	2585 LJ
18	Boehringer Ingelheim Investigational Site	Deurne		Netherlands	5751 XJ
19	Boehringer Ingelheim Investigational Site	Ewijk		Netherlands	6644 CL
20	Boehringer Ingelheim Investigational Site	Lichtenvoorde		Netherlands	7131 CM
21	Boehringer Ingelheim Investigational Site	Rijswijk		Netherlands	2281 AK
22	Boehringer Ingelheim Investigational Site	Roelofarendsveen		Netherlands	2371 RB
23	Boehringer Ingelheim Investigational Site	Rotterdam		Netherlands	3082 DC
24	Boehringer Ingelheim Investigational Site	Hamar		Norway	N-2317
25	Boehringer Ingelheim Investigational Site	Oslo		Norway	N-0159
26	Boehringer Ingelheim Investigational Site	Oslo		Norway	N-0303
27	Boehringer Ingelheim Investigational Site	Tønsberg		Norway	N-3111
28	Boehringer Ingelheim Investigational Site	Göteborg		Sweden	413 45
29	Stockholms Neuro Center	Stockholm		Sweden	112 81
30	Neurologkliniken	Stockholm		Sweden	141 86
31	Boehringer Ingelheim Investigational Site	Uppsala		Sweden	751 85
32	Läkarhuset Vällingby	Vällingby		Sweden	162 68
33	Boehringer Ingelheim Investigational Site	Västra Frölunda		Sweden	421 30
34	Boehringer Ingelheim Investigational Site	Örebro		Sweden	701 85

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Pharma GmbH & Co. KG

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00275457
• Other Study ID Numbers: 248.520
• First Posted: Jan 12, 2006
• Last Update Posted: Oct 31, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Pramipexole

Study Results

No Results Posted as of Oct 31, 2013