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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Restless Legs Syndrome

Intervention: Pramipexole 0.125 mg tablet (Drug); Pramipexole 0.5 mg tablet (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

Official title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks

Secondary outcome:

IRLS Responder

Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks

Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks

Clinical Global Impression Global Improvement (CGI-I) Responder

Patient Global Impression (PGI) Responder

Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.

Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period

IRLS Responder for Open-label Period

Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period

Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period

Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period

Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period

Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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)

Locations and Contacts

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

Additional Information

Starting date: October 2006
Last updated: June 23, 2014

Page last updated: August 23, 2015

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