- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267188
Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia
April 18, 2011 updated by: Neurocrine Biosciences
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5T 1R8
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NBI-98854
Open-label, dose titration of active drug
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Tardive Dyskinesia symptoms
Time Frame: 19 days
|
Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale
|
19 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events following dosing with NBI-98854
Time Frame: 19 days
|
Outcome assessment includes monitoring of:
|
19 days
|
Evaluate pharmacokinetics of three doses of NBI-98854
Time Frame: 19 days
|
Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.
|
19 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
December 21, 2010
First Submitted That Met QC Criteria
December 23, 2010
First Posted (ESTIMATE)
December 28, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 20, 2011
Last Update Submitted That Met QC Criteria
April 18, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBI-98854-1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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