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

NCT00390689 | Completed Phase 3 Results

• 1 other identifier: 248.627
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 34

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

Outcome Measures

Primary Outcomes (1)

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

  The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.

  Week 6 - change from baseline

Secondary Outcomes (13)

• IRLS Responder

  baseline to week 6

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

  Week 6 - change from baseline

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

  Week 6 - change from baseline

• Clinical Global Impression Global Improvement (CGI-I) Responder

  baseline to week 6

• Patient Global Impression (PGI) Responder

  baseline to week 6

Study Arms (3)

Pramipexole 0.25 mg once daily

EXPERIMENTAL

Pramipexole 0.25 mg given once daily

Drug: Pramipexole 0.125 mg tablet

Pramipexole 0.5 mg once daily

EXPERIMENTAL

Pramipexole 0.5 mg given once daily

Drug: Pramipexole 0.5 mg tablet

Pramipexole 0.75 mg once daily

EXPERIMENTAL

Pramipexole 0.75 mg given once daily

Drug: Pramipexole 0.125 mg tablet; Drug: Pramipexole 0.5 mg tablet

Interventions

Pramipexole 0.125 mg tablet DRUG

Pramipexole 0.25 mg once daily; Pramipexole 0.75 mg once daily

Pramipexole 0.5 mg tablet DRUG

Pramipexole 0.5 mg once daily; Pramipexole 0.75 mg once daily

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 20 and 80 years
• 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):
• An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
• The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
• 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.
• 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.
• Patients with a total score larger than 15 on the IRLS at Visit 2

You may not qualify if:

• 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
• Patients who cannot take adequate contraceptive measures
• Patients with a history of akathisia induced by neuroleptics
• Patients with diabetes mellitus requiring insulin therapy
• Patients who are judged to have microcytic anaemia by the investigator or sub-investigator
• 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
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (34)

248.627.037 Boehringer Ingelheim Investigational Site

Aichi-gun, Aichi, Japan

Location

248.627.014 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, Japan

Location

248.627.029 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

248.627.032 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

Location

248.627.030 Boehringer Ingelheim Investigational Site

Kagoshima, Kagoshima, Japan

Location

248.627.013 Boehringer Ingelheim Investigational Site

Kanagawa, Yokohama, Japan

Location

248.627.033 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, Japan

Location

248.627.027 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

Location

248.627.023 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, Japan

Location

248.627.024 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, Japan

Location

248.627.022 Boehringer Ingelheim Investigational Site

Kochi, Kochi, Japan

Location

248.627.034 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, Japan

Location

248.627.038 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

248.627.041 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

248.627.039 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, Japan

Location

248.627.003 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

Location

248.627.036 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, Japan

Location

248.627.025 Boehringer Ingelheim Investigational Site

Mitaka-shi, Tokyo, Japan

Location

248.627.015 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

248.627.017 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

248.627.011 Boehringer Ingelheim Investigational Site

Otaru, Hokkaido, Japan

Location

248.627.026 Boehringer Ingelheim Investigational Site

Otsu, Shiga, Japan

Location

248.627.002 Boehringer Ingelheim Investigational Site

Sakai,Osaka, Japan

Location

248.627.010 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

248.627.035 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

248.627.012 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

248.627.001 Boehringer Ingelheim Investigational Site

Shibuya-ku, Tokyo, Japan

Location

248.627.004 Boehringer Ingelheim Investigational Site

Shimotsuga-gun,Tochigi, Japan

Location

248.627.040 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

248.627.018 Boehringer Ingelheim Investigational Site

Takatsuki,Osaka, Japan

Location

248.627.028 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, Japan

Location

248.627.019 Boehringer Ingelheim Investigational Site

Tokushima, Tokushima, Japan

Location

248.627.016 Boehringer Ingelheim Investigational Site

Toyohashi, Aichi, Japan

Location

248.627.031 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, Japan

Location

MeSH Terms

Interventions

Pramipexole; Tablets

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: October 1, 2006
• Primary Completion: March 1, 2008
• Last Updated: July 2, 2014
• Results First Posted: August 25, 2009

Record last verified: 2014-04

Locations

JP (34)