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Trial record 42 of 47 for:    Parasomnias | ( Map: Japan )

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

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ClinicalTrials.gov Identifier: NCT00152997
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 31, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date October 31, 2013
Study Start Date  ICMJE August 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2005)
Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI) in the PSG
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
For primary comparison change from baseline in periodic limb movements during time in bed index (PLMI) in the PSG will be expressed.
Change History Complete list of historical versions of study NCT00152997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2008)
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 )
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • -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 )
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Restless Legs Syndrome
Intervention  ICMJE
  • Drug: Pramipexole 0.125 mg tablets
  • Drug: Pramipexole 0.125 mg tablets Placebo
Study Arms Not Provided
Publications * Inoue Y, Oka Y, Kagimura T, Kuroda K, Hirata K. Reliability, validity, and responsiveness of the Japanese version of International Restless Legs Syndrome Study Group rating scale for restless legs syndrome in a clinical trial setting. Psychiatry Clin Neurosci. 2013 Sep;67(6):412-9. doi: 10.1111/pcn.12074. Epub 2013 Aug 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2013)
41
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
42
Study Completion Date Not Provided
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00152997
Other Study ID Numbers  ICMJE 248.557
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP