Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia
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
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2010
CompletedFirst Posted
Study publicly available on registry
December 28, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 20, 2011
April 1, 2011
2 months
December 21, 2010
April 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of Tardive Dyskinesia symptoms
Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale
19 days
Secondary Outcomes (2)
Number of Participants with Adverse Events following dosing with NBI-98854
19 days
Evaluate pharmacokinetics of three doses of NBI-98854
19 days
Study Arms (1)
NBI-98854
EXPERIMENTALOpen-label, dose titration of active drug
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Toronto, Ontario, M5T 1R8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 21, 2010
First Posted
December 28, 2010
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 20, 2011
Record last verified: 2011-04