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

Boehringer Ingelheim154 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

154

Conditions

Idiopathic Restless Legs Syndrome

Interventions

Pramipexole 0.125 mg tabletDRUG

Pramipexole 0.5 mg tabletDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (34)

Outcomes

Primary Outcomes

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.

Time frame: Week 6 - change from baseline

Secondary Outcomes

IRLS Responder

The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)

Time frame: baseline to week 6

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

PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).

Time frame: Week 6 - change from baseline

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

ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)

Data from ClinicalTrials.gov

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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

...and 24 more locations