Status:
COMPLETED
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- Written informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local Institutional Review Board/Independent Ethics Committee (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 International Restless Legs Syndrome Study Group (IRLSSG) \[P03-03355\]. All four criteria must be present to fulfil the diagnosis of RLS.
- 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)
Exclusion
- 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
- Any woman of child-bearing potential not having a negative pregnancy test at screening
- Breastfeeding women
- Patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets
- Diagnosis of augmentation under previous pharmacological RLS treatment
- 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);
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00472199
Start Date
May 1 2007
Last Update
June 27 2014
Active Locations (42)
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1
248.629.4302 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
2
248.629.4304 Boehringer Ingelheim Investigational Site
Linz, Austria
3
248.629.3201 Boehringer Ingelheim Investigational Site
Edegem, Belgium
4
248.629.35801 Boehringer Ingelheim Investigational Site
Espoo, Finland