Treating Leg Symptoms in Women with X-linked Adrenoleukodystrophy: A Key to Improving Sleep and Gait Performance

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518989-27-01

Acronym

RLS

Enrollment

Registered

2024-12-17

Start date

2024-02-04

Completion date

2025-12-01

Last updated

2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless legs, X-linked adrenoleukodystrophy

Brief summary

1. Subjective total sleep time, 2. Subjective sleep latency, 3. Subjective time awake after sleep onset, 4. Depressive (PHQ-9) and anxiety (GAD-7) symptoms, 5. Quality of life measures (SF-36), 6. Functional measures: EDSS, 25-FW, and TUG

Interventions

DRUGPramipexole Viatris 0

DRUG088 mg tabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Subjective total sleep time, 2. Subjective sleep latency, 3. Subjective time awake after sleep onset, 4. Depressive (PHQ-9) and anxiety (GAD-7) symptoms, 5. Quality of life measures (SF-36), 6. Functional measures: EDSS, 25-FW, and TUG	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026