A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients (FRAMES)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03917225 |
Recruitment Status :
Completed
First Posted : April 17, 2019
Last Update Posted : September 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Friedreich Ataxia | Drug: MIN-102 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Placebo-controlled Study on the Effects of MIN-102 on Biochemical, Imaging, Neurophisyiological, and Clinical Markers in Patients With Friedreich's Ataxia |
Actual Study Start Date : | March 26, 2019 |
Actual Primary Completion Date : | August 13, 2020 |
Actual Study Completion Date : | September 14, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Active |
Drug: MIN-102
Once-daily dosing with a volume specified by the pharmacokineteic specialistto achive the desired plasma exposure. Min-102 Oral suspension, strength 15mg/ml. |
Placebo Comparator: Placebo |
Drug: Placebo
Once-daily dosing with a volume specified by the pharmacokinetic specialist. Oral Suspension. |
- Change from baseline in spinal cord area cervical segment C2-C3 [mm2] [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 12 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female subjects aged ≥12 and ≤60 years, inclusive, with a genetically confirmed diagnose of Friedreich's Ataxia.
- Be able to walk > 10 meters with support (two special sticks, stroller or accompanying person).
- Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) of < 25.
Exclusion Criteria:
- Age of onset of disease ≥25 years.
- Higher degree of cardiomyopathy assessed by echocardigram.
- Diabetes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917225
Belgium | |
Hôpital Erasme-ULB | |
Brussels, Belgium, B-1070 | |
France | |
ICM, Groupe Hospitalier Pitié Salpêtrière | |
Paris, France, 75646 | |
Germany | |
Universitätsklinikum RWTH | |
Aachen, Germany, 52074 | |
Spain | |
Hospital Sant Joan de Déu | |
Barcelona, Spain | |
Hospital Universitario La Paz | |
Madrid, Spain, 28046 |
Responsible Party: | Minoryx Therapeutics, S.L. |
ClinicalTrials.gov Identifier: | NCT03917225 |
Other Study ID Numbers: |
MT-2-03 |
First Posted: | April 17, 2019 Key Record Dates |
Last Update Posted: | September 25, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ataxia Cerebellar Ataxia Friedreich Ataxia Dyskinesias Neurologic Manifestations Nervous System Diseases Cerebellar Diseases Brain Diseases |
Central Nervous System Diseases Spinocerebellar Degenerations Spinal Cord Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mitochondrial Diseases Metabolic Diseases |