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A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients

NCT03917225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-10-13

No results posted yet for this study

Summary

Randomized, double-blind, placebo-controlled study on the effects of MIN-102 on Biochemical, Imaging, neurophysiological, and clinical markers in patients with Friedreich's Ataxia

Conditions

  • Friedreich Ataxia

Interventions

DRUG

MIN-102

Once-daily dosing with a volume specified by the pharmacokinetic specialist to achieve the desired plasma exposure. MIN-102 oral suspension, strength 15 mg/ml.

DRUG

Placebo

Once-daily dosing with a volume specified by the pharmacokinetic specialist. Oral suspension.

Sponsors & Collaborators

  • Minoryx Therapeutics, S.L.

    lead INDUSTRY

Principal Investigators

  • Alexandra Durr · ICM, Groupe Hospitalier Pitié Salpêtrière, Paris, France, 75646

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2020-08-13
Completion
2020-09-14

Countries

  • Belgium
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03917225 on ClinicalTrials.gov