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NAD+ precursor

Open Label - MIB-626 for Friedreich Ataxia

Phase 2
Waitlist Available
Led By Shana E McCormack, MD
Research Sponsored by Metro International Biotech, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety and effects of MIB-626, a substance that boosts energy production, in adults with Friedreich's Ataxia who do not have severe heart failure. The goal is to see if it can improve muscle energy levels.

Eligible Conditions
  • Friedreich Ataxia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Individuals With Treatment-emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 5.0.
Secondary study objectives
Cardiac 31-Phosphorus-Magnetic Resonance Spectroscopy (MRS): Phosphocreatine (PCr)/Adenosine Tri-Phosphate (ATP) Ratio
Concentration of Nicotinamide Adenine Dinucleotide (NAD+) in Whole Blood
Grip Strength
+1 more

Side effects data

From 2022 Phase 2 trial • 7 Patients • NCT04817111
14%
Constipation
14%
Belching
14%
Back pain
14%
Neck pain
14%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label - MIB-626

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open Label - MIB-626Experimental Treatment1 Intervention
MIB-626
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MIB-626
2021
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER
729 Previous Clinical Trials
8,470,255 Total Patients Enrolled
9 Trials studying Friedreich Ataxia
2,563 Patients Enrolled for Friedreich Ataxia
Metro International Biotech, LLCLead Sponsor
2 Previous Clinical Trials
162 Total Patients Enrolled
Shana E McCormack, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
4 Previous Clinical Trials
112 Total Patients Enrolled
~2 spots leftby Nov 2025
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