The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks
Placebo oral tablets administered daily for 5 weeks
Sleep efficiency
Time frame: Week 5
PLMS-arousal index (PLMS-AI)
Time frame: Week 5
Sleep Questionnaire Form A
Time frame: Weeks 2 and 5
Quality of Life for RLS questionnaire
Time frame: Weeks 2 and 5
Clinical Global Impressions
Time frame: Weeks 2 and 5
Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography
Time frame: Weeks 2 and 5
Total score of the severity rating scale of the International RLS (IRLS) Study Group
Time frame: Weeks 2 and 5
RLS-6 severity scales
Time frame: Weeks 2 and 5
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