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MIN-102 for Adrenoleukodystrophy (Advance Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Minoryx Therapeutics, S.L.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and between 18-65 years of age
Clinical evidence of spinal cord involvement
Must not have
Known type 1 or type 2 diabetes
Previous or current history of cancer (other than treated basal cell carcinoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will test if MIN-102 is an effective and safe treatment for male patients with AMN phenotype of X-linked adrenoleukodystrophy.
Who is the study for?
This trial is for male patients aged 18-65 with X-linked adrenoleukodystrophy (X-ALD), confirmed by specific tests and showing spinal cord involvement. It's not open to those who've taken certain diabetes drugs recently, have a history of cancer (except treated skin cancer), inflammatory brain lesions, other neurological diseases causing similar symptoms, heart failure, or had bone marrow transplants.
What is being tested?
The study compares the effects of MIN-102 against a placebo in treating AMN phenotype of X-ALD. Participants are randomly assigned to one of two groups: one receiving MIN-102 and the other a placebo. The trial is double-blind meaning neither participants nor researchers know who gets the real treatment.
What are the potential side effects?
Potential side effects aren't specified here but based on similar medications they may include digestive issues, potential liver changes, and risk of fluid retention which could affect heart function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged between 18 and 65.
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My cancer has spread to my spinal cord.
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I have been diagnosed with X-ALD through specific blood and genetic tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with diabetes.
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I have had cancer before, but not basal cell carcinoma.
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I have a history of heart failure.
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I have had a bone marrow transplant in the past.
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I have a chronic neurological condition like multiple sclerosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Minoryx Therapeutics, S.L.Lead Sponsor
4 Previous Clinical Trials
132 Total Patients Enrolled
3 Trials studying Adrenoleukodystrophy
93 Patients Enrolled for Adrenoleukodystrophy