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Treating Leg Symptoms in Woman with X-ALD
EU CTIS ID: 2024-518989-27-01
What this study is testing
To determine the prevalence of RLS in women with ALD.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Phase 1: 1. Women
- Phase 1: 2. Ability to provide verbal consent
- Phase 1: 3. A willingness and ability to comply with study procedures.
- Phase 1: 4. Age ≥18
- Phase 1: 5. Metabolically or genetically confirmed diagnosis of ALD
- Phase 2: 1. Participation in Phase 1
You likely can't join if
- Phase 1: 1. Inflammatory brain demyelination
- Phase 2: 9. Patients who are deemed poor candidates by PI discretion
- Phase 2: 1. Pregnant. Research staff perform pregnancy tests upon visit to center.
- Phase 2: 2. Participants with active or unstable major psychiatric disorder other than ALD, who, in the investigators’ judgement, require further treatment
- Phase 2: 3. Use of dopaminergic agonists or antagonists within the last 30 days
- Phase 2: 4. Alcohol use disorder within the last 30 days
See the full eligibility criteria
- Phase 1: 1. Women
- Phase 1: 2. Ability to provide verbal consent
- Phase 1: 3. A willingness and ability to comply with study procedures.
- Phase 1: 4. Age ≥18
- Phase 1: 5. Metabolically or genetically confirmed diagnosis of ALD
- Phase 2: 1. Participation in Phase 1
- Phase 2: 2. Ability to provide written informed consent
- Phase 2: 3. Women with ALD who have Restless Leg Syndrome (IRLS > 15)
- Phase 2: 4. Use of adequate contraception
- Phase 1: 1. Inflammatory brain demyelination
- Phase 2: 9. Patients who are deemed poor candidates by PI discretion
- Phase 2: 1. Pregnant. Research staff perform pregnancy tests upon visit to center.
- Phase 2: 2. Participants with active or unstable major psychiatric disorder other than ALD, who, in the investigators’ judgement, require further treatment
- Phase 2: 3. Use of dopaminergic agonists or antagonists within the last 30 days
- Phase 2: 4. Alcohol use disorder within the last 30 days
- Phase 2: 5. Methamphetamine or benzodiazepine dependence in the last 30 days
- Phase 2: 6. 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
- Phase 2: 7. Medical instability considered to interfere with study procedures
- Phase 2: 8. Renal disease judged to interfere with drug metabolism and excretion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.