Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05003648 · ClinicalTrials.gov registry record · Phase 4
Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy
A Phase 4 study of Restless Legs Syndrome and Adrenoleukodystrophy, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT05003648: Active Phase 4 study of Restless Legs Syndrome and Adrenoleukodystrophy, sponsored by Massachusetts General Hospital.
NCT05003648 is a Phase 4 study of Restless Legs Syndrome and Adrenoleukodystrophy that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 24 participants, below the 95-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05003648, a Phase 4 study of Restless Legs Syndrome and Adrenoleukodystrophy, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Change in IRLS score before and after pramipexole treatment. Scores range from 0 to 40, with higher scores representing more severe RLS symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pramipexole
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Other
- University Medical Center of Amsterdam - Amsterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 4 |
What the registry record for NCT05003648 still lists
NCT05003648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 95-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Restless Legs Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05003648 reports a single indexed study location in Massachusetts, Other.
Frequently Asked Questions
What is clinical trial NCT05003648 about?
NCT05003648 is a clinical study titled "Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy". 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 symptom...
What is the current status of trial NCT05003648?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2023-04-01. Estimated completion is 2026-05-01.
What conditions does trial NCT05003648 study?
This clinical trial studies the following conditions: Restless Legs Syndrome, Adrenoleukodystrophy.
What interventions are being tested in trial NCT05003648?
The interventions under investigation include: Placebo (DRUG), Pramipexole (DRUG).
Who is sponsoring clinical trial NCT05003648?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05003648 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Restless Legs Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05003648's enrollment target sits among peer trials
24 12th of 14 higher than 3 of 14 other Restless Legs Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Restless Legs Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
COMPLETED · Phase 4
-
Blood Changes After Exercise in Restless Legs Syndrome
RECRUITING · NA
-
Response to an Investigational Device in Patients With Restless Legs Syndrome
ACTIVE NOT RECRUITING · NA
-
A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS
ACTIVE NOT RECRUITING
-
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
ACTIVE NOT RECRUITING · Phase 1
-
A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI