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Treating Restless Leg Syndrome in Women with ALD - Part 1

Etude en cours
Recrutement en cours
PHASE 1:
In Phase 1 of this research study, we want to learn more about how common restless legs syndrome (RLS) is in women with X-linked adrenoleukodystrophy (ALD). You may be eligible to take part in Phase 1 of the study if you have been diagnosed with ALD and are a female age 18 years and older. We anticipate that 50 people at Massachusetts General Hospital (MGH) and 50 people at the University Medical Center (UMC) of Amsterdam will participate in Phase 1 of the study. Participation in Phase 1 may include the following visits:
ALD Eligibility Remote Pre-Screening Visit (V1): This visit will be conducted over the phone with a study coordinator. It will consist of a review of medical and demographic history to determine if you are eligible to participate in the study.
RLS Diagnostic Remote Visit (V2): Eligible patients will be interviewed by both an expert in ALD (Dr. Florian Eichler) and an expert in RLS (Dr. John Winkelman) to determine if you have any symptoms of RLS. This visit will also involve completion of a series of questionnaires including the following: The 12-Item Multiple Sclerosis Walking Scale (MSWS-12), Spasticity Screening Tool, The Generalized Anxiety Disorder Assessment (GAD-7), The Patient Health Questionnaire (PHQ-9), and The 36-Item Short Form Survey (SF-36).
RLS Severity Remote Visit (V3): Patients who meet the diagnostic criteria for RLS will undergo an additional telephone interview with Dr. Eichler or Dr. Winkelman to determine the severity of RLS symptoms.
Objectifs
Durée de l'étude :
23 mois
Début de l'étude :
mars 2023
Fin du recrutement :
janvier 2025
Fin de l'étude :
janvier 2025
Statut
  • Autorisé en États-Unis, Pays-Bas
  • Recrutement des patients en cours en États-Unis, Pays-Bas
Critères d'inclusion
  • Age : greater than or equal to 18 years
  • Sex : female
  • To have one of the following pathologies : X-linked Adrenoleukodystrophy / ALD (ABCD1), Adrenomyeloneuropathy / AMN
  • Subject : patient
Je satisfais à l'ensemble des critères d'inclusion
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Lieu de l'étude
  • MGH, Boston, États-Unis
  • Amsterdam UMC, Amsterdam, Pays-Bas
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