MIN-102 for Adrenoleukodystrophy

(Advance Trial)

Recruiting at 9 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Minoryx Therapeutics, S.L.

Must not be taking: Honokiol, Thiazolidinediones

Disqualifiers: Chronic neurological disease, Diabetes, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Phase II/III duration not specified

105 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two parallel-group study in male patients with the AMN phenotype of X-linked adrenoleukodystrophy (X-ALD) to assess the efficacy and safety of MIN-102 treatment. Study sites will consist of specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).

Eligibility Criteria

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.

Inclusion Criteria

I am a man aged between 18 and 65.

My cancer has spread to my spinal cord.

I have been diagnosed with X-ALD through specific blood and genetic tests.

Exclusion Criteria

I have been diagnosed with diabetes.

I have had cancer before, but not basal cell carcinoma.

You have abnormal MRI results that show inflammation or other issues not mentioned in the inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MIN-102 or placebo in a double-blind, placebo-controlled setting

Phase II/III duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension

Participants may opt into continuation of treatment with MIN-102 long-term

Treatment Details

Interventions

• MIN-102
• Placebos

Trial Overview 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.

Participant Groups

Group I: Active Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Minoryx Therapeutics, S.L.

Lead Sponsor

Trials

5

Recruited

240+