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NAD+ Precursor (NR) + Exercise for Ataxia (ExRx in FA Trial)
N/A
Recruiting
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Girls, 11 years of age and older, must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study
Males and Females, Age 10 to 40 years (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
ExRx in FA Trial Summary
This trial will use a 2x2 factorial design to test the effects of an NAD+ precursor (NR) and exercise on VO2max and Si in Friedreich's Ataxia (FA).
Who is the study for?
This trial is for individuals aged 10-40 with a confirmed diagnosis of Friedreich's Ataxia, weighing over 24 kg, and not currently meeting recommended exercise guidelines. Participants must be able to perform physical activities and use contraception if applicable. Exclusions include sensitivity to NR, certain medication use, pregnancy, severe heart or kidney conditions, uncontrolled arrhythmias, inability to perform required exercises or MRI procedures.Check my eligibility
What is being tested?
The study tests the effects of Nicotinamide Riboside (NR), an NAD+ precursor supplement combined with an exercise regimen on aerobic capacity (VO2max) and glucose homeostasis in patients with Friedreich's Ataxia. It uses a randomized placebo-controlled design where participants are assigned by chance to receive either NR or a placebo while following an exercise program.See study design
What are the potential side effects?
Potential side effects may include reactions related to Nicotinamide Riboside such as digestive issues or skin flushing. Exercise might cause muscle soreness or fatigue. Specific side effects will depend on individual tolerance and health status.
ExRx in FA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a girl aged 11 or older, not pregnant, and will use birth control during the study.
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I am between 10 and 40 years old.
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I weigh more than 24 kilograms.
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I have been diagnosed with Friedrich's Ataxia.
ExRx in FA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Within-Participant Change in V02 Max (Maximal Oxygen Uptake on Cardiopulmonary Exercise Testing)
Secondary outcome measures
Within-Participant Change in Whole Body Insulin Sensitivity (Si)
ExRx in FA Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotinamide Riboside (NR)Experimental Treatment1 Intervention
Investigators will use Good Manufacturing Process (GMP)-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA). Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight > 72 kg: 900 mg po qd x 12 wks.
For individuals with weight > 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Group II: Exercise Intervention and PlaceboExperimental Treatment2 Interventions
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance training days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the Placebo.
Group III: Exercise Intervention and NRExperimental Treatment2 Interventions
The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands. All sessions will begin with stretching and brief aerobic warm-up exercise on the in-home bike trainer. On resistance training days, subjects will be given instructions to complete circuits of resistance exercises.
Participants in this arm will receive both the Exercise Intervention and the NR.
Group IV: PlaceboPlacebo Group1 Intervention
Matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule). Doses of placebo will match the body weight schema for dosing of NR. Investigators dose based on body weight, and monitor for adverse effects (AEs).
For individuals with weight > 72 kg: 900 mg po qd x 12 wks.
For individuals with weight > 48 kg and ≤ 72 kg: 600 mg po qd x 12 wks.
For individuals with weight 24 ≤ 48 kg: 300 mg po qd x 12 wks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide Riboside
2022
N/A
~160
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
6,952,734 Total Patients Enrolled
1 Trials studying Friedreich Ataxia
203 Patients Enrolled for Friedreich Ataxia
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,195 Total Patients Enrolled
9 Trials studying Friedreich Ataxia
2,488 Patients Enrolled for Friedreich Ataxia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,311,032 Total Patients Enrolled
1 Trials studying Friedreich Ataxia
10 Patients Enrolled for Friedreich Ataxia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that makes it unsafe for you to have an MRI scan.You are allergic to NR.Your liver function tests show significant abnormalities.Kids and teens should do activities that strengthen their muscles at least 3 days a week as part of their physical activity routine.I have heart rhythm problems that are not under control.I am taking higher than normal doses of steroids.I am a girl aged 11 or older, not pregnant, and will use birth control during the study.I cannot pedal on my own in a fitness test at 55 rpm.I am between 10 and 40 years old.My HgbA1c is above 8.5% and/or I need insulin for my diabetes.I cannot sit and pedal a tricycle by myself.I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.Your recent heart test shows that your heart is pumping blood normally.I am not taking medications that increase the risk of nerve damage.I weigh more than 24 kilograms.Your heart test (ECG) done within the past year did not show any important irregularities in your heartbeat.My heart's left ventricle is not pumping well (LVEF < 45%).Your blood tests show low levels of hemoglobin (below 10 g/dL) or platelets (below 100K), which could cause anemia or bleeding problems.You are not currently following the exercise guidelines recommended for Americans.You have medical reasons that make it unsafe for you to take an exercise test.I have been diagnosed with Friedrich's Ataxia.I cannot lie flat for 60-90 minutes.My kidney function is reduced based on blood tests.I do at least 1 hour of physical activity daily.Adults should do exercises that make their muscles stronger, like lifting weights or doing push-ups, at least 2 days a week.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Intervention and NR
- Group 2: Nicotinamide Riboside (NR)
- Group 3: Placebo
- Group 4: Exercise Intervention and Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial accept participants younger than seventy-five?
"Those between the ages of 10 and 40 are eligible to enter this trial, while patients under 18 or over 65 can take part in other clinical studies; there are 18 available for minors and 34 for seniors."
Answered by AI
To what extent is recruitment being conducted for this trial?
"Affirmative. According to information accessible on clinicaltrials.gov, the trial is currently seeking participants and was initially posted on September 3rd 2020 with a subsequent update occurring on September 21st 2022. A total of 72 individuals are required for the study at one location only."
Answered by AI
Is enrollment in this research endeavor still ongoing?
"Evidenced on clinicaltrials.gov, this medical examination is presently accepting enrollees. It was first advertised on September 3rd 2020 and the latest update occurred in late September 2022."
Answered by AI
What are the criteria that qualify individuals to participate in this trial?
"Prospective participants of this research endeavour must be diagnosed with Friedreich Ataxia and between the ages 10 to 40. In total, 72 people are required for enrolment."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Children's Hospital of Philadelphia
How many prior treatments have patients received?
0
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