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An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Apr 1, 2032 to Apr 2, 2034v14 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 63 to 56
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 15 to 11
    • Study description expanded, about 16 words
  2. Site contacts updated at 11 of 12 sitesv13
  3. Study sites: 10 to 12v12
  4. Re-verified, no change to tracked fieldsv11
  5. Site details revised at 1 of 10 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 7 to 10v9
  2. Enrollment target: 33 to 63v8 Show 5 more changesShow less
    • Study sites: 6 to 7
    • Secondary endpoints: 8 to 15
    • Study description expanded, about 44 words
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 2 words
  3. Study sites: 5 to 6v7
  4. Study sites: 4 to 5v6
  5. Study sites: 2 to 4
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 1 word
    v5
  6. Eligibility criteria revised
    • Secondary endpoints revised (8)
    • Study description shortened, about 12 words
    v4
  7. Study sites: 1 to 2
    • Eligibility criteria expanded, about 31 words
    • Study description expanded, about 1 word
    v3
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Moderna
49 trials monitored
See 3 trials at risk
The primary objective of this study is to evaluate the long-term safety and clinical activity of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in other clinical studies of mRNA-3705.
Trial Details
NCT Number NCT05295433
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)		 Methylmalonic Acidemia
Related terms Genetic Diseases, Inborn, Metabolism, Inborn Errors, Methylmalonic acidemia
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov