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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 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.

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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.

Interventions

  • DRUG Placebo
  • DRUG Pramipexole

Study Locations (2)

Massachusetts

  • Massachusetts General Hospital - Boston

Other

  • University Medical Center of Amsterdam - Amsterdam

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-04-01
Est. Completion 2026-05-01
Phase Phase 4

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT05003648

The ClinicalTrials.gov registry entry for NCT05003648 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 14 other Restless Legs Syndrome trials with a reported enrollment target (75% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.