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Virus Therapy
Long-Term Safety of mRNA-3705 for Methylmalonic Acidemia
Phase 1 & 2
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, year 8
Awards & highlights
Study Summary
This trial is looking at the long-term safety of a drug called mRNA-3705 in people with a rare genetic disorder called methylmalonic acidemia.
Who is the study for?
This trial is for people with Methylmalonic Acidemia who were in a previous study (mRNA-3705-P101). They must have finished the earlier trial or moved to this one because they missed doses due to COVID-19 vaccination.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of mRNA-3705, a treatment for those with isolated methylmalonic acidemia caused by MUT deficiency, based on their prior participation in an initial study.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any long-term safety issues related to the use of mRNA-3705 as it continues from the previous study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, year 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, year 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Secondary outcome measures
Change in Blood Methylmalonic Acid and 2-Methylcitric Acid (2-MC) Levels (Primary Biomarkers) From Baseline up to 8 Years
Change in Caregiver Reported Global Impression of Improvement (CrGI-I) Score
Change in Caregiver Reported Global Impression of Severity (CrGI-S) Score
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: mRNA-3705Experimental Treatment1 Intervention
Participants will receive mRNA-3705 at the same dose levels at the same dosing interval (every 2 weeks [Q2W], or every 3 weeks [Q3W]) last received in the clinical study of mRNA-3705 in which they initially participated, unless the Sponsor recommends modification.
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
106 Previous Clinical Trials
61,376,893 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I missed doses in a previous study due to COVID-19 vaccination.I have had a liver or kidney transplant.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-3705
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any vacancies left in this experiment for participants?
"Affirmative, the details available on clinicaltrials.gov indicate that this experiment is currently recruiting volunteers. Starting from March 8th 2022 and last modified on September 29th 2022, 33 participants are expected to join at one site."
Answered by AI
How many subjects have been recruited for this research project?
"Affirmative. Clinicaltrials.gov attests that this medical experiment, which was initially published on March 8th 2022, is actively seeking participants. The study requires 33 patients from a single site to partake in the research."
Answered by AI
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