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Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia (Kinect 4)

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ClinicalTrials.gov Identifier: NCT02405091
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief Summary:
Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: NBI-98854 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Study Start Date : March 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arm Intervention/treatment
Experimental: Dose Group 1
Fixed dose of NBI-98854 administered once daily for 48 weeks
Drug: NBI-98854
Experimental: Dose Group 2
Fixed dose of NBI-98854 administered once daily up to 48 weeks
Drug: NBI-98854



Primary Outcome Measures :
  1. Number of patients with adverse events following dosing with NBI-98854 [ Time Frame: Up to 52 weeks ]

Secondary Outcome Measures :
  1. Severity of tardive dyskinesia (TD) symptoms assessed by Abnormal Involuntary Movements Scale (AIMS) [ Time Frame: Day -1; end of weeks 4, 8, 12, 24, 36, and 48; end of week 52 or at early termination ]
  2. Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) [ Time Frame: end of Weeks 4, 8, 12, 24, 36 and 48; end of week 52 or at early termination ]
  3. Patient Global Impression of Change (PGIC) [ Time Frame: end of Weeks 4, 8, 12, 24, 36 and 48; end of week 52 or at early termination ]
  4. Tardive Dyskinesia Impact Scale (TDIS) [ Time Frame: end of Weeks 4, 8, 12, 24, 36 and 48; end of week 52 or at early termination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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 general good health.
  8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
  9. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, 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, 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 prior to screening (some exceptions allowed).
  7. Have received an investigational drug within 30 days before 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. Are currently pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405091


  Show 48 Study Locations
Sponsors and Collaborators
Neurocrine Biosciences

Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02405091     History of Changes
Other Study ID Numbers: NBI-98854-1402
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Dyskinesia, Drug-Induced
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs