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NCT01736553 · ClinicalTrials.gov registry record
Spinal Muscular Atrophy (SMA) Biomarkers Study in the Immediate Postnatal Period of Development
A clinical trial, sponsored by Ohio State University.
- Completed
- Registry status
- 53
- Enrollment target
NCT01736553: Completed study, sponsored by Ohio State University.
NCT01736553 is a clinical trial that has completed, run by Ohio State University. The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01736553 has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- 53 participants
- Enrollment target
Study Summary
Spinal muscular atrophy (SMA) is the leading genetic cause of death of infants. Strong preclinical evidence suggests that effective therapy must be delivered as early as possible to prevent progression of the disease. The primary study objective will be to identify prognostic and surrogate biomarkers of disease progression that will facilitate the execution of therapeutic SMA clinical trials in infants.
Primary Outcome
Describe \& compare the distribution of motor function assessments over the first two years of life in SMA vs. healthy control infants. The TIMPSI is used to assess the postural and selective control of movement typically used by infants younger than 5 months. The TIMPSI scores were related to an infant's ability to reach. The TIMPSI is a 29-item evaluation that contains 3 item sets: a Screening set, an Easy set, and a Hard set. The Screening set consists of 11 items from the TIMP, each with a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-09 |
What the finished NCT01736553 record still lists
NCT01736553 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01736553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01736553 about?
NCT01736553 is a clinical study titled "Spinal Muscular Atrophy (SMA) Biomarkers Study in the Immediate Postnatal Period of Development". Spinal muscular atrophy (SMA) is the leading genetic cause of death of infants. Strong preclinical evidence suggests that effective therapy must be delivered as early as possible to prevent progression of the disease. The primary study objective will be to identify prognostic and surrogate biomarker...
What is the current status of trial NCT01736553?
This trial is currently completed. The enrollment target is 53 participants. The study started on 2012-12. Estimated completion is 2015-09.
Who is sponsoring clinical trial NCT01736553?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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