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NCT01791725 · ClinicalTrials.gov registry record · Phase 2
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
A Phase 2 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01791725: Completed Phase 2 study, sponsored by OPKO Health.
NCT01791725 is a Phase 2 study that has completed, run by OPKO Health. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01791725, a Phase 2 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.
Primary Outcome
For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC.
Interventions
- DRUG Placebo
- DRUG ELND005
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT01791725 record still lists
NCT01791725 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01791725 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01791725 about?
NCT01791725 is a clinical study titled "A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia". This is a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks. This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without dementia.
What is the current status of trial NCT01791725?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2013-09. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01791725?
The interventions under investigation include: Placebo (DRUG), ELND005 (DRUG).
Who is sponsoring clinical trial NCT01791725?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01791725's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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