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MIN-102 for Adrenoleukodystrophy (Advance Trial)

Q: What precedent does this research have?

<p>Active is being tested in a Phase 2 &#x26; 3 drug approval stage trial, sponsored by Minoryx Therapeutics, S.L., which began in 2017. This was the first of 242 total trials conducted for Active across 8 countries and 3 cities.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in 96 weeks

Awards & highlights

Advance Trial 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.Check my eligibility

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.See study design

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.

Advance Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Advance Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and in 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the efficacy of MIN-102 on the progression of adrenomyeloneuropathy (AMN) in male patients as determined by a motor function test.

Secondary outcome measures

EDSS (Expanded Disability Status Scale )

Incidence of cerebral inflammatory lesions

Quality of life scales (Euroqol)

+2 more

Advance Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If I qualify, can I be a subject in this clinical trial?

"Currently, this study is looking for 105 male patients that have adrenoleukodystrophy and are aged 18-65."

Answered by AI

What precedent does this research have?

"Active is being tested in a Phase 2 & 3 drug approval stage trial, sponsored by Minoryx Therapeutics, S.L., which began in 2017. This was the first of 242 total trials conducted for Active across 8 countries and 3 cities."

Answered by AI

Could you tell me if the age limit for participants is 55 years or older?

"The age limit for applicants of this clinical trial is 65. If an individual participant is younger than 18 or older there are 8 other trials they may be eligible for."

Answered by AI

Are there other examples of Active being used in a scientific study?

"Active is currently being tested in 1 Phase 3 clinical trial with many more trials planned. The primary location for these studies is Budapest, but there are 10 other sites around the world where Active is being investigated."

Answered by AI

Are investigators looking for more people to join this research project?

"This study is no longer looking for new participants. This particular trial was first posted on December 8th, 2017 and received its last update on October 29th, 2021. There are other studies you may be eligible for – 14 trials recruiting patients with adrenoleukodystrophy and 1 seeking Active participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.

2017. "A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03231878.

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