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NCT01942590 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Clenbuterol in Individuals With Late-onset Pompe Disease and Receiving Enzyme Replacement Therapy
A Phase 1 study, sponsored by Dwight Koeberl, M.D., Ph.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01942590: Completed Phase 1 study, sponsored by Dwight Koeberl, M.D., Ph.D..
NCT01942590 is a Phase 1 study that has completed, run by Dwight Koeberl, M.D., Ph.D.. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01942590, a Phase 1 study, has completed, sponsored by Dwight Koeberl, M.D., Ph.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Funding Source- FDA OOPD The purpose of this study is to investigate the safety and efficacy of clenbuterol on motor function in individuals with late-onset Pompe disease (LOPD) who are treated with enzyme replacement therapy (ERT).
Primary Outcome
Worsening muscle involvement, as defined by \>3x increase in CK from baseline that is \>2x the upper limit of normal
Interventions
- DRUG Placebo
- DRUG Clenbuterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-09-02 |
| Phase | Phase 1 |
What the finished NCT01942590 record still lists
NCT01942590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01942590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01942590 about?
NCT01942590 is a clinical study titled "Safety and Efficacy of Clenbuterol in Individuals With Late-onset Pompe Disease and Receiving Enzyme Replacement Therapy". Funding Source- FDA OOPD The purpose of this study is to investigate the safety and efficacy of clenbuterol on motor function in individuals with late-onset Pompe disease (LOPD) who are treated with enzyme replacement therapy (ERT).
What is the current status of trial NCT01942590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-09. Estimated completion is 2016-09-02.
What interventions are being tested in trial NCT01942590?
The interventions under investigation include: Placebo (DRUG), Clenbuterol (DRUG).
Who is sponsoring clinical trial NCT01942590?
This trial is sponsored by Dwight Koeberl, M.D., Ph.D., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01942590's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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