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A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00390689
  Purpose

The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this tr ial is to investigate the long term safety and efficacy of pramipexole in RLS.


Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole 0.125 mg tablet
Drug: Pramipexole 0.5 mg tablet
Phase III

MedlinePlus related topics: Restless Legs
Drug Information available for: Pramipexol Pramipexole dihydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
Official Title: A Randomised, Double Blind Study Comparing Fixed Doses of 0.25mg, 0.5mg and 0.75mg Pramipexole to Investigate the Efficacy and Safety in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by 46 Weeks Open Label Long Term Study to Investigate the Safety and Efficacy of Pramipexole

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Changes from baseline in RLSRS total score [ Time Frame: 6 weeks for DB phase and 52 weeks for open label phase ]

Secondary Outcome Measures:
  • Pittsburgh sleep quality index (PSQI) Epworth sleepiness scale (ESS) Clinical global impression (CGI) Patient global impression (PGI) Augmentation Safety [ Time Frame: 6 weeks for DB phase and 52 weeks for open label phase ]

Enrollment: 154
Study Start Date: October 2006
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pramipexole 0.125 mg tablet
    Up-titrated according to PGI (0.125mg-0.75mg)
    Drug: Pramipexole 0.5 mg tablet
    Up-titrated according to PGI (0.125mg-0.75mg)
  Eligibility

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

Inclusion Criteria:

  1. Male or female patients between 20 and 80 years
  2. Patients with a diagnosis of RLS according to the following diagnosis criteria of NIH/IRLSSG:

    1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the 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.
  3. Patients with a total score larger than 15 on the RLS rating scale at Visit 2

Exclusion Criteria:

  1. Premenopausal women who meet any of the following 1) to 3) 1) Patients who are pregnant or possibly pregnant 2) Patients who are lactating 3) Patients who wish to become pregnant during the study period
  2. Patients who cannot take adequate contraceptive measures
  3. Patients with a history of akathisia induced by neuroleptics
  4. Patients with diabetes mellitus requiring insulin therapy
  5. Patients who are judged to have microcytic anaemia by the investigator or sub-investigator
  6. Patients with a history or signs of peripheral neuropathy, myelopathy, multiple sclerosis, Parkinson?s disease or other neurological diseases that may result in the occurrence of secondary RLS in the physical function tests or neurological tests
  7. Patients with other sleep disorders such as abnormal behaviour during REM sleep, narcolepsy and sleep apnoea syndrome (patients with an apnoea-hypopnoea index (AHI) exceeding 15 determined by polysomnography at the relevant trial site or those with loud snoring at least 5 nights/week and an experience of respiratory arrest during sleep or excessive daytime sleepiness)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390689

Locations
Japan
Yoyogi Somnological Clinic, NEURO Inst
Shibuya-ku, Tokyo, Japan
Han-nan hospital
Sakai,Osaka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Ishikane Hospital
Sapporo, Hokkaido, Japan
Wellness Boyo Clinic
Otaru, Hokkaido, Japan
Aoba Hospital
Sendai, Miyagi, Japan
Yokohama city minato Red Cross Hospital
Kanagawa, Yokohama, Japan
Kawashima Neurology Clinic
Fujisawa, Kanagawa, Japan
Kume Clinic
Nagoya, Aichi, Japan
Toyohashi Mates Daini Clinic
Toyohashi,?Aichi, Japan
Kyotani clinic
Osaka, Osaka, Japan
Osaka Medical College Hospital
Takatsuki,Osaka, Japan
Kochi Kagamigawa Hospital
Kochi,Kochi, Japan
K-you health care Co. Kirigaoka tsuda hospital
Kitakyusyu, Fukuoka, Japan
You Clinic
Kitakyusyu, Fukuoka, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, Japan
Shiga University of Medical Science Hospital
Otsu, Shiga, Japan
Southern TOHOKU Research Institute for Neuroscience Southern
Koriyama, Fukushima, Japan
SAINO clinic
Tokorozawa, Saitama, Japan
Fukuoka Urasoe Clinic
Fukuoka, Fukuoka, Japan
Takaoka Hospital
Kagoshima, Kagoshima, Japan
Nakamura Clinic
Urasoe, Okinawa, Japan
Tokunaga Clinic Respiration&Sleep
Hiroshima, Hiroshima, Japan
Tokushima?University Hospital
Tokushima, Tokushima, Japan
Miura Mental Clinic
Sapporo, Hokkaido, Japan
Dokkyo University Hospital
Shimotsuga-gun,Tochigi, Japan
Kanazawa-ekimae GUSSURI Clinic
Kanazawa, Ishikawa, Japan
Musashi Clinic
Kodaira, Tokyo, Japan
Jikei University School of Medicine Hospital
Minato-ku, Tokyo, Japan
Aichi Medical University Hospital
Aichi-gun, Aichi, Japan
Ohta Nishinouchi Hospital
Koriyama, Fukushima, Japan
Kuwamizu hospital
Kumamoto, Kumamoto, Japan
Yotsuya International Medicine Clinic
Shinjuku-ku, Tokyo, Japan
Ota Memorial Sleep Center
Kawasaki, Kanagawa, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.627
Study First Received: October 19, 2006
Last Updated: July 2, 2008
ClinicalTrials.gov Identifier: NCT00390689  
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Parasomnias
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Protective Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Syndrome
Psychomotor Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009