Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059602) titled 'Development of Patient-Reported and Observer-Reported Outcome Measures for Quality of Life in Patients with Metachromatic Leukodystrophy, Adrenoleukodystrophy, and Krabbe Disease' on Nov. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Metachromatic leukoencephalopathy, Adrenoleukodystrophy, Krabbe disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Development of Patient-Reported Outcomes for Patients with Leukodystrophy
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Individuals aged 18 years or older at the time of consent acquisition; for patients under 18 years of age or those with neurological symptoms or other conditions making self-response difficult, the consent will be obtained from a caregiver aged 18 years or older.
2) Gender is not a factor.
3) Individuals diagnosed with MLD, ALD, or Krabbe disease and their caregivers.
Key exclusion criteria - 1) Individuals hospitalized due to acute symptoms
2) Other individuals deemed unsuitable as research subjects by the principal investigator (or co-investigator)
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 06 Day
Date of IRB - 2025 Year 10 Month 14 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068187
Disclaimer: Curated by HT Syndication.
