Active — Not RecruitingPhase 4

Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy

United States, Netherlands24 participantsStarted 2023-04-01

Plain-language summary

The investigators recently observed that up to 25% of women with X-linked adrenoleukodystrophy (ALD) have moderate to severe Restless Leg Syndrome (RLS). In this study, the investigators aim to estimate the prevalence of RLS among women with ALD and to assess whether pramipexole improves RLS symptoms as well as sleep and gait measures in women with ALD.

Who can participate

Age range18 Years – 75 Years

SexFEMALE

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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

Exclusion criteria

✕. Participation in Phase 1
✕. Ability to provide written informed consent
✕. Women with ALD who have Restless Leg Syndrome (IRLS \> 15)
✕. Pregnant. Research staff perform pregnancy tests upon visit to center.
✕. Participants with active or unstable major psychiatric disorder other than ALD, who, in the investigators' judgement, require further treatment
✕. Use of dopaminergic agonists or antagonists within the last 30 days
✕. Alcohol use disorder within the last 30 days
✕. History of being treated for restless legs syndrome, specifically with dopamine agonist medications

What they're measuring

Change in the International Restless Legs Severity (IRLS) score

Timeframe: pre-intervention, week 8, week 17

Prevalence of Restless Leg Syndrome in Women with X-linked Adrenoleukodystrophy

Timeframe: pre-intervention

Trial details

NCT IDNCT05003648

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-15

View on ClinicalTrials.gov More Adrenoleukodystrophy trials