Restless Legs Syndrome
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
Interventions
DRUGcabergoline
Cabergoline oral tablets: 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 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events
DRUGlevodopa
Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS * Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale * No previous treatment for RLS or dissatisfaction with their current therapy
Exclusion criteria
* Not available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS) | Week 6 |
| Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Global Impression | Weeks 6 and 30 |
| Sleep questionnaire form A | Weeks 6 and 30 |
| IRLSSG-RS | Week 30 |
| Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram | Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2 |
| RLS quality-of-life questionnaire | Weeks 6 and 30 |
| Rating of severity of RLS before bedtime (RLS-6 scale) | Weeks 6 and 30 |
| Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales) | Weeks 6 and 30 |
| Global rating of quality of sleep (RLS-6 scale) | Weeks 6 and 30 |
| Rating of severity of RLS at night (RLS-6 scale) | Weeks 6 and 30 |
| Clinical Global Impression | Weeks 6 and 30 |
Countries
Austria, Germany, Sweden, Switzerland
Outcome results
None listed