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

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pramipexole
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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 Exclusion criteria: 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) Other clinically significant metabolic-endocrine, haematological, gastro-intestinal disease or pulmonary disease. Poorly controlled cardiovascular disease 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 Presence of any other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnoea syndrome 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 Participation in a drug study within two months prior to the start of this study History of or clinical signs for any form of epilepsy or seizures apart from fever related seizures in early childhood History of or clinical signs of malign neoplasm 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

Sites / Locations

  • Univ.-Klinik für Neurologie
  • Univ.-Klinik für Neurologie
  • AKH der Stadt Linz
  • Confraternität Privatklinik
  • AKH Universitätsklinik für Psychiatrie
  • Sonderkrankenanstalt für neurologischen und
  • Wilhelminenspital der Stadt Wien
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • emovis GmbH
  • Facharzt für Neurologie
  • Boehringer Ingelheim Investigational Site
  • ClinPharm International GmbH & Co. KG
  • Universitätsklinikum Giessen und Marburg
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Stockholms Neuro Center
  • Neurologkliniken
  • Boehringer Ingelheim Investigational Site
  • Läkarhuset Vällingby
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Mean change from baseline to week 6 on the RLSRS +
CGI-I responders (much and very much improved)

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2006
Last Updated
October 30, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00275457
Brief Title
Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
346 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pramipexole
Primary Outcome Measure Information:
Title
Mean change from baseline to week 6 on the RLSRS +
Title
CGI-I responders (much and very much improved)
Secondary Outcome Measure Information:
Title
RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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) Other clinically significant metabolic-endocrine, haematological, gastro-intestinal disease or pulmonary disease. Poorly controlled cardiovascular disease 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 Presence of any other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnoea syndrome 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 Participation in a drug study within two months prior to the start of this study History of or clinical signs for any form of epilepsy or seizures apart from fever related seizures in early childhood History of or clinical signs of malign neoplasm 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
Univ.-Klinik für Neurologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Univ.-Klinik für Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
AKH der Stadt Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Confraternität Privatklinik
City
Wien
ZIP/Postal Code
1080
Country
Austria
Facility Name
AKH Universitätsklinik für Psychiatrie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Sonderkrankenanstalt für neurologischen und
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Wilhelminenspital der Stadt Wien
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Dürrheim-Sunthausen
ZIP/Postal Code
78073
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10625
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Facharzt für Neurologie
City
Emmendingen
ZIP/Postal Code
79312
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
ClinPharm International GmbH & Co. KG
City
Leipzig
ZIP/Postal Code
04229
Country
Germany
Facility Name
Universitätsklinikum Giessen und Marburg
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Beek en Donk
ZIP/Postal Code
5741 AR
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Den Haag
ZIP/Postal Code
2585 LJ
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Deurne
ZIP/Postal Code
5751 XJ
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Ewijk
ZIP/Postal Code
6644 CL
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Lichtenvoorde
ZIP/Postal Code
7131 CM
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Rijswijk
ZIP/Postal Code
2281 AK
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Roelofarendsveen
ZIP/Postal Code
2371 RB
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Rotterdam
ZIP/Postal Code
3082 DC
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Hamar
ZIP/Postal Code
N-2317
Country
Norway
Facility Name
Boehringer Ingelheim Investigational Site
City
Oslo
ZIP/Postal Code
N-0159
Country
Norway
Facility Name
Boehringer Ingelheim Investigational Site
City
Oslo
ZIP/Postal Code
N-0303
Country
Norway
Facility Name
Boehringer Ingelheim Investigational Site
City
Tønsberg
ZIP/Postal Code
N-3111
Country
Norway
Facility Name
Boehringer Ingelheim Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Stockholms Neuro Center
City
Stockholm
ZIP/Postal Code
112 81
Country
Sweden
Facility Name
Neurologkliniken
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Boehringer Ingelheim Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Läkarhuset Vällingby
City
Vällingby
ZIP/Postal Code
162 68
Country
Sweden
Facility Name
Boehringer Ingelheim Investigational Site
City
Västra Frölunda
ZIP/Postal Code
421 30
Country
Sweden
Facility Name
Boehringer Ingelheim Investigational Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.520_U05-1394-01.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/248/248.520_literature.pdf
Description
Related Info

Learn more about this trial

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

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