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NCT03325010 · ClinicalTrials.gov registry record · Phase 2

Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

A Phase 2 study, sponsored by Neurocrine Biosciences.

Completed
Registry status
Phase 2
Development phase
127
Enrollment target

NCT03325010 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 127 participants.

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The verdict

NCT03325010, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
127 participants
Enrollment target

Study Summary

This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.

Interventions

  • DRUG Placebo oral capsule
  • DRUG Valbenazine

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2017-10-05
Est. Completion 2018-11-16
Phase Phase 2

Sponsor

Neurocrine Biosciences

65 total trials

What the Registry Record Tells You About NCT03325010

The ClinicalTrials.gov registry entry for NCT03325010 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.

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

NCT03325010 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03325010 about?

NCT03325010 is a clinical study titled "Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome". This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.

What is the current status of trial NCT03325010?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2017-10-05. Estimated completion is 2018-11-16.

What interventions are being tested in trial NCT03325010?

The interventions under investigation include: Placebo oral capsule (DRUG), Valbenazine (DRUG).

Who is sponsoring clinical trial NCT03325010?

This trial is sponsored by Neurocrine Biosciences, which has 65 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.