Long-Term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe RLS
Sponsored by:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00472199
Purpose
The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome in comparison to placebo.
The key secondary objectives are to assess the effects on clinical global impressions - global improvement (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life (SF-36) and on safety (based on AE profile) of pramipexole in comparison to placebo.
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: A Phase IV Randomised, Double-Blind, Placebo-Controlled, Dose Titration Trial With Pramipexole (Sifrol?, Mirapexin?) 0.125-0.75 mg/Day Per os to Investigate the Long-Term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
The primary endpoint will be the change from baseline after 26 weeks of treatment in the total score of the International Restless Legs Syndrome Study Group Rating Scale (IRLS) under treatment with pramipexole in comparison to placebo.
Secondary Outcome Measures:
CGI I responder rate, IRLS responder rate, Patient Global Impression (PGI) responder rate, RLS 6 scores, Mood disturbance (item 10 of the IRLS scale), VAS score for pain in limbs, RLS QoL total score, SF 36 dimensions
Total Enrollment: 320
Expected completion: November 2009
Eligibility
Ages Eligible for Study: 18 Years - 85 Years, Genders Eligible for Study: Both
Criteria
Written informed consent consistent with ICH-GCP and local IRB/IEC requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments
Male or female out-patients aged 18-85 years
Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG [P03-03355]. All four criteria must be present to fulfil the diagnosis of RLS:
An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs)
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues
The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present).
RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (Visit 2)
IRLS total score >15 at baseline (Visit 2)
1. Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner?s surgical sterilization 2. Any woman of child-bearing potential not having a negative pregnancy test at screening 3. Breastfeeding women 4. Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets 5. Diagnosis of augmentation under previous pharmacological RLS treatment 6. Concomitant or previous pharmacologic therapy as follows:
Any intake of dopamine agonists within 14 days prior to baseline (Visit 2)
Any intake of levodopa within 14 days prior to baseline (Visit 2)
Unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00472199
Boehringer Ingelheim Investigational Site, Co. Kildare, Ireland; Not yet recruiting
Boehringer Ingelheim Investigational Site, Co. Tipperary, Ireland; Not yet recruiting
Netherlands
Boehringer Ingelheim Investigational Site, Bennebroek, Netherlands; Not yet recruiting
Boehringer Ingelheim Investigational Site, Oude Pekela, Netherlands; Recruiting
Boehringer Ingelheim Investigational Site, Rijswijk, Netherlands; Not yet recruiting
Boehringer Ingelheim Investigational Site, Hoogwoud, Netherlands; Not yet recruiting
Slovakia
Boehringer Ingelheim Investigational Site, Kosice, Slovakia; Not yet recruiting
Boehringer Ingelheim Investigational Site, Brezno, Slovakia; Not yet recruiting
Boehringer Ingelheim Investigational Site, Martin, Slovakia; Not yet recruiting
Boehringer Ingelheim Investigational Site, Bratislava, Slovakia; Not yet recruiting
Study chairs or principal investigators
Boehringer Ingelheim Study Coordinator, Study Chair, Boehringer Ingelheim Pharmaceuticals
More Information
Study ID Numbers: 248.629
Last Updated: May 10, 2007
Record first received: May 10, 2007
ClinicalTrials.gov Identifier: NCT00472199 Health Authority: Germany: Federal Institute for Drugs and Medical Devices
