Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03444038 · ClinicalTrials.gov registry record · Phase 2

Open-Label Safety and Tolerability Study 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
85
Enrollment target

NCT03444038: Completed Phase 2 study, sponsored by Neurocrine Biosciences.

NCT03444038 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03444038, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
85 participants
Enrollment target

Study Summary

This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.

Primary Outcome

A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing. All qualifying TEAE are reported regardless of threshold.

Interventions

  • DRUG Valbenazine

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2018-02-08
Est. Completion 2019-07-12
Phase Phase 2
Neurocrine Biosciences

65 total trials

What the finished NCT03444038 record still lists

NCT03444038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).

The record links to 0 conditions, and to 1 intervention - of which Valbenazine is the first listed.

NCT03444038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03444038 about?

NCT03444038 is a clinical study titled "Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome". This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.

What is the current status of trial NCT03444038?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2018-02-08. Estimated completion is 2019-07-12.

What interventions are being tested in trial NCT03444038?

The interventions under investigation include: Valbenazine (DRUG).

Who is sponsoring clinical trial NCT03444038?

This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03444038's enrollment target sits among peer trials

85 820th of 2000 higher than 1,179 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00842283 · 85 participants

    Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target

  • NCT02133196 · 85 participants · Phase 2

    T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

  • NCT03823144 · 85 participants · NA

    Intravital Microscopy in Human Solid Tumors

  • NCT03875638 · 85 participants · Phase 2

    Treating Hyperexcitability in AD With Levetiracetam

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT03444038, the US trial registry maintained by the National Library of Medicine. NCT03444038 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.