restless legs syndrome x-gebonden adrenoleukodystrofie
Conditions
Interventions
Intervention (if applicable): Study medication: pramipexole or placebo
capsules, 0.125 mg
Day 0-7: 0.125 mg, QD
Day 7-14: 0.125 mg, QD or BID
Day 14-60: 0.125 mg QD, 0.125 mg BID or 0.125mg QID
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: PHASE 1 (PREVALENCE STUDY) Inclusion Criteria: - Women of any ethnic origin. - Ability to provide verbal consent - A willingness and ability to comply with study procedures. - Age 18-75 years - Metabolically or genetically confirmed diagnosis of ALD PHASE 2 (CROSS-OVER STUDY) Inclusion Criteria: - Participation in Phase 1 - Ability to provide written informed consent - Women with ALD who have Restless Leg Syndrome (IRLS > 15)
Exclusion criteria
Exclusion criteria: 1. Pregnant. Research staff perform pregnancy tests upon visit to center. 2. Participants with active or unstable major psychiatric disorder other than ALD, who, in the investigators* judgement, require further treatment 3. Use of dopaminergic agonists or antagonists within the last 30 days 4. Alcohol use disorder within the last 30 days 5. History of being treated for restless legs syndrome, specifically with dopamine agonist medications 6. Methamphetamine or benzodiazepine dependence in the last 30 days 7. Neurological disorder or cardiovascular disease raising safety concerns about use of pramipexole and/or judged to interfere with ability to assess efficacy of the treatment 8. Medical instability considered to interfere with study procedures 9. Renal disease judged to interfere with drug metabolism and excretion 10. Patients who are deemed a fall risk as determined by the PI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: IRLS Score - The International Restless Legs Severity Scale (IRLS) is a severity rating scale developed by the International Restless Legs Syndrome Study Group. This scale consists of 10 items that evaluate RLS symptoms, sleep disturbance from RLS, impact of RLS on daily activities, and mood disturbance resulting from RLS symptoms. The scores for the 10 items are summed to produce a total score, which ranges from 0 (no severity) to 40 (most severe). | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory Aims (PHASE 2): - To determine whether pramipexole will have improved self-reported and objective sleep metrics (e.g., quality, disturbance, sleep latency and duration, and periodic limb movements of sleep) in women with ALD. - To determine whether pramipexole will improve measures of walking and motor performance (25 feet walk test as well as the timed up and go test). | — |
Countries
Netherlands
Outcome results
None listed