A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

NCT02274558 | Completed Phase 3 Results

• 1 other identifier: NBI-98854-1304
• Study Type: interventional
• Target: 234
• Locations: 3 countries
• Sites: 54

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Conditions

Tardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

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

  Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. 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 of Change - TD (CGI-TD) at Week 6

  Week 6

• Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6

  Week 6

Study Arms (3)

NBI-98854 40 mg

EXPERIMENTAL

NBI-98854 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.

Drug: NBI-98854; Drug: Placebo

NBI-98854 80 mg

EXPERIMENTAL

Subjects randomized to the NBI-98854 80 mg dose will receive NBI-98854 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by NBI-98854 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning between 7:00am - 10:00am for 5 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose.

Drug: NBI-98854; Drug: Placebo

Placebo

EXPERIMENTAL

Placebo administered as two (2) placebo capsules, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and be randomized to either a 40 mg or 80 mg dose. Subjects re-randomized to receive NBI-98854 80 mg will receive 40 mg for the first week.

Drug: NBI-98854; Drug: Placebo

Interventions

NBI-98854 DRUG

NBI-98854 40 mg capsules

NBI-98854 40 mg; NBI-98854 80 mg; Placebo

Placebo DRUG

NBI-98854 placebo capsules

NBI-98854 40 mg; NBI-98854 80 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study.
• Female subjects must not be pregnant.
• Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder.
• Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
• Have moderate or severe TD.
• If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
• Be in good general health.
• Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
• Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, phencyclidine, cocaine, opiates, or cannabinoids

You may not qualify if:

• Have an active, clinically significant unstable medical condition within 1 month prior to screening.
• Have a known history of substance dependence, or substance (drug) or alcohol abuse
• Have a significant risk of suicidal or violent behavior.
• Have a known history of neuroleptic malignant syndrome.
• Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
• Have a cancer diagnosis within 3 years of screening (some exceptions allowed)
• Have received an investigational drug within 30 days prior to screening or plan to use an investigational drug (other than NBI-98854) during the study.
• Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
• Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
• Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
• Are currently pregnant or breastfeeding.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (54)

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Glendale, California, United States

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Irvine, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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National City, California, United States

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Norwalk, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Bradenton, Florida, United States

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Hialeah, Florida, United States

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Kissimmee, Florida, United States

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Leesburg, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Chicago, Illinois, United States

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Oak Brook, Illinois, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Worcester, Massachusetts, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Amherst, New York, United States

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Cedarhurst, New York, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Pinehurst, North Carolina, United States

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Dayton, Ohio, United States

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Shaker Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Conshohocken, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Phoenixville, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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DeSoto, Texas, United States

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Fort Worth, Texas, United States

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Irving, Texas, United States

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Petersburg, Virginia, United States

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Spokane, Washington, United States

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Caguas, Puerto Rico

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San Juan, Puerto Rico

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Related Publications (5)

• 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: 31617235 DERIVED

• Correll CU, Cutler AJ, Kane JM, McEvoy JP, Liang GS, O'Brien CF. Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study. J Clin Psychiatry. 2018 Dec 18;80(1):18m12278. doi: 10.4088/JCP.18m12278.

  PMID: 30695293 DERIVED

• Factor SA, Remington G, Comella CL, Correll CU, Burke J, Jimenez R, Liang GS, O'Brien CF. The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. J Clin Psychiatry. 2017 Nov/Dec;78(9):1344-1350. doi: 10.4088/JCP.17m11777.

  PMID: 29141124 DERIVED

• 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: 28404690 DERIVED

• Hauser RA, Factor SA, Marder SR, Knesevich MA, Ramirez PM, Jimenez R, Burke J, Liang GS, O'Brien CF. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017 May 1;174(5):476-484. doi: 10.1176/appi.ajp.2017.16091037. Epub 2017 Mar 21.

  PMID: 28320223 DERIVED

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: October 22, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: July 1, 2016
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

CA (4); PR (2); US (48)