← Back to Search

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 weeks
Treatment ~ Varies
Follow Up ~baseline, year 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, year 8 for reporting.

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 more

Trial 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.

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
106 Previous Clinical Trials
61,376,893 Total Patients Enrolled

Media Library

mRNA-3705 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05295433 — Phase 1 & 2
Methylmalonic Acidemia Research Study Groups: mRNA-3705
Methylmalonic Acidemia Clinical Trial 2023: mRNA-3705 Highlights & Side Effects. Trial Name: NCT05295433 — Phase 1 & 2
mRNA-3705 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05295433 — Phase 1 & 2

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
~42 spots leftby Apr 2032