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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 is a Phase 2 study that has completed, run by OPKO Health. The registered enrollment target is 23 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG ELND005

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2013-09
Est. Completion 2014-06
Phase Phase 2

Sponsor

OPKO Health

32 total trials

What the Registry Record Tells You About NCT01791725

The ClinicalTrials.gov registry entry for NCT01791725 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01791725 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.