Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00152997
First received: September 9, 2005
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

The objective of this trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International Restless Legs Syndrome Study Group (IRLSSG) as a sub-study.


Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole 0.125 mg tablets
Drug: Pramipexole 0.125 mg tablets Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI) in the PSG

Secondary Outcome Measures:
  • Total score of RLS severity scale-J by IRLSSG, Periodic Limb Movements during Sleep Index (PLMSI) in the PSG Periodic Limb Movements during Wakefulness Index (PLMWI) in the PSG Periodic Limb Movements in Sleep with Arousal Index (PLMAI) in the PSG )

Enrollment: 41
Study Start Date: August 2004
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

According to the essential diagnostic criteria for RLS of NIH and IRLSSG, the following four all criterias must be presented:

  1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in legs
  2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
  3. 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
  4. 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

    • PLM (during time in bed) index of at least 5 per hour (in the worst affected leg) at Visit 3
    • Total score of RLS severity scale-Japanese version by IRLSSG > 15 at Visit 3
    • At least 1 time per week of RLS symptoms interfering with sleep within the last one month at Visit 1.

Exclusion Criteria:

  1. Pre-menopausal women who meet any one of the following (1) - (3):

    • Pregnant or possibly pregnant
    • In lactation
    • Desire to be pregnant during study period Even when a patient was confirmed not to fall under the criteria above at initiation of study, if the patient is of childbearing potential, pregnancy tests should be performed when possible. If pregnancy test is positive, the investigational product should be discontinued.
  2. Males not using an adequate form of contraception.
  3. Patients who took the neuroleptics within 4 weeks before the screening Visit 1, or neuroleptic-induced akathisia.
  4. Patients who can not stop the treatment with medication or dietary supplements, which could significantly influence RLS symptoms to wash-out at least 14 days before drug administration (refer to Appendix 3 for prohibited medication), e.g. dopaminergic drugs (levodopa or dopamine agonists) or antidopaminergic drugs (neuroleptics or metoclopramide etc.), MAO inhibitors, sympathomimetics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, folic acid, vitamin B12, antihistaminics, lithium, melatonin.
  5. Patients with diabetes mellitus requiring insulin therapy.
  6. Patients with microcytic anemia at investigators discretion.
  7. 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.
  8. Other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep apnea syndrome (with AHI >15 at Visit 3, or a history of loud snoring occurring at least 5 nights a week combined with a history of breathing pauses during sleep and excessive daytime sleepiness).
  9. Clinically significant renal disease or creatinine higher than upper limit of normal (ULN) at screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152997

Locations
Japan
Boehringer Ingelheim Investigational Site
Akita, Akita, Japan
Boehringer Ingelheim Investigational Site
Kochi, Kochi, Japan
Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Otaru,Hokkaido, Japan
Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan
Boehringer Ingelheim Investigational Site
Shibuya,Tokyo, Japan
Boehringer Ingelheim Investigational Site
Takatsuki, Osaka, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00152997     History of Changes
Other Study ID Numbers: 248.557
Study First Received: September 9, 2005
Last Updated: October 30, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014