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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT02274558
First received: October 22, 2014
Last updated: October 12, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Tardive Dyskinesia
Drug: NBI-98854
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel, Fixed-Dose Study to Assess the Efficacy, Safety, and Tolerability of NBI-98854 for the Treatment of Tardive Dyskinesia

Further study details as provided by Neurocrine Biosciences:

Primary Outcome Measures:
  • Severity of tardive dyskinesia (TD) symptoms assessed by Abnormal Involuntary Movements Scale (AIMS), change from baseline [ Time Frame: Baseline, Week 6 ]

Secondary Outcome Measures:
  • Clinical Global Impression of Change - TD (CGI-TD) [ Time Frame: Week 6 ]
  • Tardive Dyskinesia Impact Scale (TDIS) [ Time Frame: Week 6 ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 6 ]
  • Percentage of subjects classified as responders based on AIMS dyskinesia total score % change from baseline [ Time Frame: Baseline, Week 6 ]
  • Percentage of subjects classified as responders based on CGI-TD [ Time Frame: Week 6 ]

Enrollment: 234
Study Start Date: October 2014
Study Completion Date: July 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NBI-98854 40 mg
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
NBI-98854 40 mg capsules
Drug: Placebo
NBI-98854 placebo capsules
Experimental: NBI-98854 80 mg
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
NBI-98854 40 mg capsules
Drug: Placebo
NBI-98854 placebo capsules
Experimental: Placebo
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
NBI-98854 40 mg capsules
Drug: Placebo
NBI-98854 placebo capsules

Detailed Description:
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Female subjects must not be pregnant.
  3. Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder.
  4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
  5. Have moderate or severe TD.
  6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
  7. Be in good general health.
  8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, phencyclidine, cocaine, opiates, or cannabinoids

Exclusion Criteria:

  1. Have an active, clinically significant unstable medical condition within 1 month prior to screening.
  2. Have a known history of substance dependence, or substance (drug) or alcohol abuse
  3. Have a significant risk of suicidal or violent behavior.
  4. Have a known history of neuroleptic malignant syndrome.
  5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
  6. Have a cancer diagnosis within 3 years of screening (some exceptions allowed)
  7. 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.
  8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
  9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
  10. Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
  11. Are currently pregnant or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02274558

  Show 54 Study Locations
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
Principal Investigator: Chris O'Brien, MD Neurocrine Biosciences
  More Information

Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02274558     History of Changes
Other Study ID Numbers: NBI-98854-1304
Study First Received: October 22, 2014
Last Updated: October 12, 2016

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017