← Back to Search

NAD+ precursor

Open Label - MIB-626 for Friedreich Ataxia

Q: Has recruitment for this research commenced?

<p>As per clinicaltrials.gov, this medical trial is not currently enrolling patients; the original posting was on May 17th 2021 and the latest update was October 26th 2022. However, there are 46 other studies looking for volunteers at present.</p>

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

Study Summary

This trial tests a new drug to treat Friedreich's Ataxia, a disease that affects the nervous system. The goal is to see if the drug is safe and if it improves symptoms.

Eligible Conditions

Friedreich Ataxia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

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

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

Primary outcome measures

Percentage of Individuals With Treatment-emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 5.0.

Secondary outcome measures

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%

Study treatment Arm

Open Label - MIB-626

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,581,000 Total Patients Enrolled

9 Trials studying Friedreich Ataxia

2,561 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

192 Total Patients Enrolled

Frequently Asked Questions

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

Have any regulatory authorities sanctioned this treatment?

"This particular therapy is estimated to have a safety rating of 2 out of 3, as there has only been supporting evidence for its security and not yet any confirmation that it yields clinically relevant benefits."

Answered by AI

Does the protocol encompass elderly individuals aged 85 and above?

"This clinical trial is accepting adults of legal age (18 years and older) up to 64 years old."

Answered by AI

What criteria must be met for a person to participate in this scientific experiment?

"The current clinical trial is open to 10 individuals between the age of 18 and 64 who are living with friedreich ataxia. To be eligible, patients must meet the following requirements: male or female, aged >=18 but <65 years old."

Answered by AI

Has recruitment for this research commenced?

"As per clinicaltrials.gov, this medical trial is not currently enrolling patients; the original posting was on May 17th 2021 and the latest update was October 26th 2022. However, there are 46 other studies looking for volunteers at present."

Answered by AI

Recent research and studies

Annals of Clinical and Translational NeurologyJournal

Progression of Friedreich Ataxia: Quantitative Characterization over 5 Years

Patel, Maya, Charles J. Isaacs, Lauren Seyer, Karlla Brigatti, Sarah Gelbard, Cassandra Strawser, Debbie Foerster, et al.. 2016. “Progression of Friedreich Ataxia: Quantitative Characterization over 5 Years”. Annals of Clinical and Translational Neurology. Wiley. doi:10.1002/acn3.332.

JCI InsightJournal

Muscle Oxidative Phosphorylation Quantitation Using Creatine Chemical Exchange Saturation Transfer (crcest) MRI in Mitochondrial Disorders

DeBrosse, Catherine, Ravi Prakash Reddy Nanga, Neil Wilson, Kevin D’Aquilla, Mark Elliott, Hari Hariharan, Felicia Yan, et al.. 2016. “Muscle Oxidative Phosphorylation Quantitation Using Creatine Chemical Exchange Saturation Transfer (crcest) MRI in Mitochondrial Disorders”. JCI Insight. American Society for Clinical Investigation. doi:10.1172/jci.insight.88207.

clinicaltrials.govStudy

NAD+ Precursor Supplementation in Friedreich's Ataxia

Shana McCormack 2021. "NAD+ Precursor Supplementation in Friedreich's Ataxia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817111.