A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.

NCT ID: NCT00390689

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

Brief Summary

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 trial is to investigate the long term safety and efficacy of pramipexole in RLS.

Conditions

Idiopathic Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pramipexole 0.25 mg once daily

Pramipexole 0.25 mg given once daily

Group Type: EXPERIMENTAL

Pramipexole 0.125 mg tablet

Intervention Type: DRUG

Pramipexole 0.5 mg once daily

Pramipexole 0.5 mg given once daily

Group Type: EXPERIMENTAL

Pramipexole 0.5 mg tablet

Intervention Type: DRUG

Pramipexole 0.75 mg once daily

Pramipexole 0.75 mg given once daily

Group Type: EXPERIMENTAL

Pramipexole 0.125 mg tablet

Intervention Type: DRUG

Pramipexole 0.5 mg tablet

Intervention Type: DRUG

Interventions

Pramipexole 0.125 mg tablet

Intervention Type: DRUG

Pramipexole 0.5 mg tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients between 20 and 80 years

2. Patients with a diagnosis of restless legs syndrome (RLS) according to the following diagnosis criteria of National institute of health (NIH)/International restless legs syndrome study group (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 IRLS 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 Rapid eye movement (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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

248.627.037 Boehringer Ingelheim Investigational Site

Aichi-gun, Aichi, , Japan

248.627.014 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, , Japan

248.627.029 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

248.627.032 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, , Japan

248.627.030 Boehringer Ingelheim Investigational Site

Kagoshima, Kagoshima, , Japan

248.627.013 Boehringer Ingelheim Investigational Site

Kanagawa, Yokohama, , Japan

248.627.033 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, , Japan

248.627.027 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, , Japan

248.627.023 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, , Japan

248.627.024 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, , Japan

248.627.022 Boehringer Ingelheim Investigational Site

Kochi, Kochi, , Japan

248.627.034 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, , Japan

248.627.038 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, , Japan

248.627.041 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, , Japan

248.627.039 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, , Japan

248.627.003 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, , Japan

248.627.036 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, , Japan

248.627.025 Boehringer Ingelheim Investigational Site

Mitaka-shi, Tokyo, , Japan

248.627.015 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

248.627.017 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

248.627.011 Boehringer Ingelheim Investigational Site

Otaru, Hokkaido, , Japan

248.627.026 Boehringer Ingelheim Investigational Site

Otsu, Shiga, , Japan

248.627.002 Boehringer Ingelheim Investigational Site

Sakai,Osaka, , Japan

248.627.010 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

248.627.035 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

248.627.012 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

248.627.001 Boehringer Ingelheim Investigational Site

Shibuya-ku, Tokyo, , Japan

248.627.004 Boehringer Ingelheim Investigational Site

Shimotsuga-gun,Tochigi, , Japan

248.627.040 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

248.627.018 Boehringer Ingelheim Investigational Site

Takatsuki,Osaka, , Japan

248.627.028 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, , Japan

248.627.019 Boehringer Ingelheim Investigational Site

Tokushima, Tokushima, , Japan

248.627.016 Boehringer Ingelheim Investigational Site

Toyohashi, Aichi, , Japan

248.627.031 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, , Japan

Countries

Japan

Other Identifiers

248.627

Identifier Type: -

Identifier Source: org_study_id