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Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia

This study has been completed.
Sponsor:
Information provided by:
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT01267188
First received: December 21, 2010
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and 50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects with schizophrenia or schizoaffective disorder.


Condition Intervention Phase
Tardive Dyskinesia
 Drug: NBI-98854
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Dose Titration Study to Evaluate the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Neurocrine Biosciences:

Primary Outcome Measures:
  • Assessment of Tardive Dyskinesia symptoms [ Time Frame: 19 days ] [ Designated as safety issue: No ]
    Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale


Secondary Outcome Measures:
  • Number of Participants with Adverse Events following dosing with NBI-98854 [ Time Frame: 19 days ] [ Designated as safety issue: Yes ]

    Outcome assessment includes monitoring of:

    • Adverse events
    • Clinical laboratory tests
    • Vital signs
    • Physical examinations
    • 12-lead electrocardiogram (ECG)

  • Evaluate pharmacokinetics of three doses of NBI-98854 [ Time Frame: 19 days ] [ Designated as safety issue: No ]
    Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.


Estimated Enrollment: 10
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NBI-98854
Open-label, dose titration of active drug
 Drug: NBI-98854
powder in bottle, prepared doses at 12.5, 25, and 50 mg q.d. administered for up to 12 days consisting of three treatment periods of 4 days each

Detailed Description:

This is a Phase 2, open-label, dose titration study to assess the efficacy and safety of three once daily (q.d.) doses (12.5, 25, and 50 mg) of NBI-98854 administered once daily for up to 12 days consisting of three treatment periods of 4 days each (Periods 1, 2, and 3). The starting dose will be 12.5 mg q.d. (Period 1), and this dose will be escalated to 25 mg q.d. (Period 2) and then to 50 mg q.d. (Period 3) based upon each subject's ability to tolerate NBI-98854. Progression to the next dose level will be based upon the subject's ability to tolerate the previous dose and the Investigator's review of adverse events and safety data. For subjects who do not tolerate a dose increase, the dose may be decreased to the dose that was previously administered (i.e., 25 mg to 12.5 mg, 50 mg to 25 mg) and continued at that dose for the remainder of the study treatment. Up to 10 medically stable subjects with schizophrenia or schizoaffective disorder who have moderate or severe symptoms of TD will be enrolled as outpatients.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females (non-childbearing potential) aged 18 to 65 years (both inclusive).
  • Have moderate or severe Tardive Dyskinesia symptoms (Total AIMS score of at least 9)
  • Have a clinical diagnosis of schizophrenia or schizoaffective disorder.
  • Receiving a stable dose of antipsychotic medication for a minimum of 30 days or have stable psychiatric status.
  • Doses of concurrent medications and the conditions being treated have been stable for a minimum of 30 days and expected to remain stable during the study.
  • Are in good general health and expected to complete the clinical study as designed.
  • Have a body mass index (BMI) of 18 to 38 kg/m^2.
  • Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

  • Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
  • Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start.
  • Have a known history of neuroleptic malignant syndrome.
  • Have a significant risk of suicidal or violent behavior.
  • Receiving medication for the treatment of Tardive Dyskinesia
  • Receiving any excluded concomitant medication as specified in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267188

Locations
Canada, Ontario
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Neurocrine Biosciences
  More Information

No publications provided

Responsible Party: Christopher O'Brien, MD / Chief Medical Officer, Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT01267188     History of Changes
Other Study ID Numbers: NBI-98854-1001
Study First Received: December 21, 2010
Last Updated: April 18, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dyskinesias
Psychotic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013