Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome
Intervention: Pramipexole 0.125 mg tablets (Drug); Pramipexole 0.125 mg tablets Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim
Summary
The objective of this trial is to investigate the efficacy and safety of pramipexole
(0. 125-0. 75 mg) orally once daily as compared with placebo for 6 weeks in patients with
primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese
version of the RLS rating scale by the International Restless Legs Syndrome Study Group
(IRLSSG) as a sub-study.
Clinical Details
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pramipexole With the Dose Range From 0.125 mg to 0.75 mg Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome.
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Primary Endpoint: Decrease in periodic limb movements during time in bed index (PLMI) in the PSG
Secondary outcome: Total score of RLS severity scale-J by IRLSSG, Periodic Limb Movements during Sleep Index (PLMSI) in the PSG Periodic Limb Movements during Wakefulness Index (PLMWI) in the PSG Periodic Limb Movements in Sleep with Arousal Index (PLMAI) in the PSG )
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
According to the essential diagnostic criteria for RLS of NIH and IRLSSG, the following
four all criterias must be presented:
1. An urge to move the legs, usually accompanied or caused by uncomfortable and
unpleasant sensations in 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
- PLM (during time in bed) index of at least 5 per hour (in the worst affected
leg) at Visit 3
- Total score of RLS severity scale-Japanese version by IRLSSG > 15 at Visit 3
- At least 1 time per week of RLS symptoms interfering with sleep within the last
one month at Visit 1.
Exclusion Criteria:
1. Pre-menopausal women who meet any one of the following (1) - (3):
- Pregnant or possibly pregnant
- In lactation
- Desire to be pregnant during study period Even when a patient was confirmed not
to fall under the criteria above at initiation of study, if the patient is of
childbearing potential, pregnancy tests should be performed when possible. If
pregnancy test is positive, the investigational product should be discontinued.
2. Males not using an adequate form of contraception.
3. Patients who took the neuroleptics within 4 weeks before the screening Visit 1, or
neuroleptic-induced akathisia.
4. Patients who can not stop the treatment with medication or dietary supplements, which
could significantly influence RLS symptoms to wash-out at least 14 days before drug
administration (refer to Appendix 3 for prohibited medication), e. g. dopaminergic
drugs (levodopa or dopamine agonists) or antidopaminergic drugs (neuroleptics or
metoclopramide etc.), MAO inhibitors, sympathomimetics, antidepressants, hypnotics,
any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts,
folic acid, vitamin B12, antihistaminics, lithium, melatonin.
5. Patients with diabetes mellitus requiring insulin therapy.
6. Patients with microcytic anemia at investigators discretion.
7. History or clinical signs of peripheral neuropathy (PNP) of any origin in physical,
neurological examination, myelopathy or multiple sclerosis or any other neurological
disease, with potential to secondarily cause RLS symptoms.
8. Other sleep disorder, such as, REM sleep behaviour disorder, narcolepsy or sleep
apnea syndrome (with AHI >15 at Visit 3, or a history of loud snoring occurring at
least 5 nights a week combined with a history of breathing pauses during sleep and
excessive daytime sleepiness).
9. Clinically significant renal disease or creatinine higher than upper limit of normal
(ULN) at screening.
Locations and Contacts
Boehringer Ingelheim Investigational Site, Akita, Akita, Japan
Boehringer Ingelheim Investigational Site, Kochi, Kochi, Japan
Boehringer Ingelheim Investigational Site, Kurume, Fukuoka, Japan
Boehringer Ingelheim Investigational Site, Otaru,Hokkaido, Japan
Boehringer Ingelheim Investigational Site, Sakai, Osaka, Japan
Boehringer Ingelheim Investigational Site, Shibuya,Tokyo, Japan
Boehringer Ingelheim Investigational Site, Takatsuki, Osaka, Japan
Additional Information
Starting date: August 2004
Last updated: October 30, 2013
|