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Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome
This study has been completed.
First Received: March 27, 2008   Last Updated: July 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00654498
  Purpose

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)


Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75mg Pramipexole (Sifrol) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • the primary endpoints are compare the IRLS score change from baseline after 6 weeks of treatment [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • IRLS responders rate PGI responder rate [ Time Frame: 6 weeks ]

Enrollment: 305
Study Start Date: March 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent consistent with ICH/GCP and local legislation given prior to any study procedures.
  2. Ability and willingness to comply with study treatment regimen and to attend study assessments.
  3. Male or female out-patients aged 18-80 years.
  4. Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG
  5. RLS rating scale for severity total score >15.
  6. RLS symptoms present at least 2 to 3 days per week during the last 3 months.

Exclusion Criteria:

  1. 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)
  2. Current treatment with medication or dietary supplements, which could significantly influence RLS symptoms,e.g. dopaminergic (other than levodopa or dopamine agonists) or anti-dopaminergic drugs, non-selective MAO inhibitors, sympathomimetics, neuroleptics, anti-depressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, Folic acid, vitamin B12, antihistaminics, lithium, metoclopramide or Withdrawal symptoms caused by stopping any of the drugs above
  3. Confirmed diagnose of diabetic nephropathy or clinically significant renal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654498

Locations
China
248.630.02 Boehringer Ingelheim Investigational Site
Shanghai, China
248.630.03 Boehringer Ingelheim Investigational Site
Shanghai, China
248.630.04 Boehringer Ingelheim Investigational Site
Beijing, China
248.630.05 Boehringer Ingelheim Investigational Site
Beijing, China
248.630.06 Boehringer Ingelheim Investigational Site
Beijing, China
248.630.07 Boehringer Ingelheim Investigational Site
Beijing, China
248.630.08 Boehringer Ingelheim Investigational Site
Beijing, China
248.630.09 Boehringer Ingelheim Investigational Site
Nanjing, China
248.630.12 Boehringer Ingelheim Investigational Site
Qingdao, China
248.630.11 Boehringer Ingelheim Investigational Site
Xian, Shanxi Province, China
248.630.13 Boehringer Ingelheim Investigational Site
Wuhan, China
248.630.14 Boehringer Ingelheim Investigational Site
Haerbin, China
248.630.15 Boehringer Ingelheim Investigational Site
Guangzhou, China
248.630.01 Boehringer Ingelheim Investigational Site
Shanghai, China
248.630.16 Boehringer Ingelheim Investigational Site
Suzhou, China
248.630.10 Boehringer Ingelheim Investigational Site
Hangzhou, China
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.630
Study First Received: March 27, 2008
Last Updated: July 20, 2009
ClinicalTrials.gov Identifier: NCT00654498     History of Changes
Health Authority: China: State Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Antioxidants
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dopamine Agonists
Dyskinesias
Pramipexol
Sleep Disorders, Intrinsic
Signs and Symptoms
Dopamine
Mental Disorders
Restless Legs Syndrome
Neurologic Manifestations
Dopamine Agents
Neurobehavioral Manifestations

Additional relevant MeSH terms:
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Sleep Disorders
Antiparkinson Agents
Psychomotor Agitation
Dopamine Agonists
Pramipexol
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
Syndrome
Restless Legs Syndrome
Psychomotor Disorders
Neurobehavioral Manifestations
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Dyskinesias
Protective Agents
Pharmacologic Actions
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 09, 2009