NCT01733121

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 10, 2017

Completed
Last Updated

August 10, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

November 20, 2012

Results QC Date

May 11, 2017

Last Update Submit

July 11, 2017

Conditions

Tardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

  • Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6

    The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

    Baseline and Week 6

Secondary Outcomes (2)

  • Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6

    Week 6

  • AIMS Dyskinesia Total Score Change From Baseline at Week 6

    Week 6

Study Arms (2)

NBI-98854

EXPERIMENTAL

Dose titration to determine a subject's optimal dose in the range of 25 to 75 mg NBI-98854. Dose titration is performed in increments of 25 mg. NBI-98854 administered as one (1) 25 mg capsule, two (2) 25 mg capsules, or one (1) 25 mg capsule and one (1) 50 mg capsule by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.

Drug: NBI-98854

Placebo

PLACEBO COMPARATOR

Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.

Drug: Placebo

Interventions

NBI-98854DRUG

25 mg capsule

NBI-98854
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have one of the following clinical diagnoses for at least 3 months prior to screening a) schizophrenia or schizoaffective disorder; b) mood disorder; or c) gastrointestinal disorder (e.g., gastroparesis, gastroesophageal reflux disease)
  • Have a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening.
  • Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.
  • Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
  • Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
  • Female subjects must not be pregnant.
  • Be in good general health and expected to complete the clinical study as designed.
  • Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
  • Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.
  • Have a negative alcohol breath test at screening and study start.

You may not qualify if:

  • Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
  • Have a known history of neuroleptic malignant syndrome.
  • Have a significant risk of suicidal or violent behavior.
  • Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine.
  • Receiving medication for the treatment of tardive dyskinesia.
  • Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
  • Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
  • Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
  • Have had previous exposure with NBI-98854.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Costa Mesa, California, 92626, United States

Location

Unknown Facility

Fountain Valley, California, 92708, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Englewood, Colorado, 80113, United States

Location

Unknown Facility

Boca Raton, Florida, 33486, United States

Location

Unknown Facility

Hialeah, Florida, 33012, United States

Location

Unknown Facility

Miami, Florida, 33125, United States

Location

Unknown Facility

Chicago, Illinois, 60640, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

Farmington Hills, Michigan, 48334, United States

Location

Unknown Facility

Beachwood, Ohio, 44122, United States

Location

Unknown Facility

Middleburg Heights, Ohio, 44130, United States

Location

Unknown Facility

Conshohocken, Pennsylvania, 19428, United States

Location

Unknown Facility

Phoenixville, Pennsylvania, 19460, United States

Location

Unknown Facility

Bedford, Texas, 76021, United States

Location

Unknown Facility

DeSoto, Texas, 75115, United States

Location

Unknown Facility

Houston, Texas, 77008, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Irving, Texas, 75062, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Richland, Washington, 99352, United States

Location

Unknown Facility

Caguas, 00725, Puerto Rico

Location

Related Publications (2)

  • Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31.

    PMID: 31617235DERIVED

  • Grigoriadis DE, Smith E, Hoare SRJ, Madan A, Bozigian H. Pharmacologic Characterization of Valbenazine (NBI-98854) and Its Metabolites. J Pharmacol Exp Ther. 2017 Jun;361(3):454-461. doi: 10.1124/jpet.116.239160. Epub 2017 Apr 12.

    PMID: 28404690DERIVED

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Neurocrine Medical Information
Organization
Neurocrine Biosciences, Inc.
medinfo@neurocrine.com
877-641-3461

Study Officials

  • Chris O'Brien, MD

    Neurocrine Biosciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 26, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 10, 2017

Results First Posted

August 10, 2017

Record last verified: 2017-07

Locations

PR(1)US(21)