NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
This study is currently recruiting participants.
Verified May 2013 by Neurocrine Biosciences
Sponsor:
Neurocrine Biosciences
Information provided by (Responsible Party):
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT01733121
First received: November 20, 2012
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Tardive Dyskinesia |
Drug: NBI-98854 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy 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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Severity of TD symptoms assessed by AIMS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]Change from Baseline, Proportion of responders based on reduction from baseline
- Severity of TD symptoms assessed by AIMS [ Time Frame: Week 4 ] [ Designated as safety issue: No ]Change from Baseline, Proportion of responders based on reduction from baseline
- Severity of TD symptoms assessed by AIMS [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Change from Baseline, Proportion of responders based on reduction from baseline
Secondary Outcome Measures:
- Clinical global impression - global improvement of TD (CGI-TD) [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]Clinician's perspective of the participant's overall improvement of TD symptoms over time
- Number of Participants with Adverse Events following dosing with NBI-98854 [ Time Frame: Up to 14 weeks ] [ Designated as safety issue: Yes ]Proportion of subjects reporting adverse events
- Evaluation of plasma concentrations of NBI-98854 and metabolites following repeated daily doses of NBI-98854 [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]Plasma samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.
Other Outcome Measures:
- Exploratory efficacy assessment of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Patient Global Impression of Change (PGIC) questionnaire.
- Exploratory efficacy assessment of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms [ Time Frame: Baseline; Weeks 2 and 6 ] [ Designated as safety issue: No ]Tardive Dyskinesia Ratings Scale (TDRS)
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NBI-98854
Dose titration to determine a subject's optimal dose in the range of 25 to 75 mg NBI-98854. Dose titration is performed in increments of 25 mg. NBI-98854 administered as one (1) 25 mg capsule, two (2) 25 mg capsules, or one (1) 25 mg capsule and one (1) 50 mg capsule by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.
|
Drug: NBI-98854
25 mg capsule
Drug: NBI-98854
50 mg capsule
|
|
Placebo Comparator: Placebo
Capsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
|
Drug: Placebo |
Detailed Description:
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-titration study to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to subject's optimal dose in the range of 25 to 75 mg) compared to placebo, administered once daily (q.d.) for a total of 6 weeks of treatment. Approximately 90 medically stable male and female subjects with one of the following clinical diagnoses will be enrolled: schizophrenia or schizoaffective disorder with neuroleptic-induced TD; mood disorder with neuroleptic-induced TD; or gastrointestinal disorder with metoclopramide-induced TD.
For subjects randomized to active treatment, the starting dose will be 25 mg NBI 98854, which may be escalated in increments of 25 mg every 2 weeks to a maximum of 75 mg to achieve an optimal dose of NBI-98854 for each subject
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have one of the following clinical diagnoses for at least 3 months prior to screening a) schizophrenia or schizoaffective disorder; b) mood disorder; or c) gastrointestinal disorder (e.g., gastroparesis, gastroesophageal reflux disease)
- Have a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening.
- Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.
- Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
- Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
- Female subjects must not be pregnant.
- Be in good general health and expected to complete the clinical study as designed.
- Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
- Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.
- Have a negative alcohol breath test at screening and study start.
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(nicotine and caffeine dependence are not exclusionary).
- Have a known history of neuroleptic malignant syndrome.
- Have a significant risk of suicidal or violent behavior.
- Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine.
- Receiving medication for the treatment of tardive dyskinesia.
- Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
- Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
- Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- Have had previous exposure with NBI-98854.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733121
Contacts
| Contact: Cheryl Chen | 858-617-7744 | cechen@neurocrine.com |
Locations
| United States, California | |
| Recruiting | |
| Costa Mesa, California, United States, 92626 | |
| Recruiting | |
| Fountain Valley, California, United States, 92708 | |
| Recruiting | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| Not yet recruiting | |
| Englewood, Colorado, United States, 80113 | |
| United States, Florida | |
| Recruiting | |
| Boca Raton, Florida, United States, 33486 | |
| Recruiting | |
| Hialeah, Florida, United States, 33012 | |
| Recruiting | |
| Miami, Florida, United States, 33125 | |
| United States, Illinois | |
| Recruiting | |
| Chicago, Illinois, United States, 60640 | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Michigan | |
| Recruiting | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Ohio | |
| Recruiting | |
| Beachwood, Ohio, United States, 44122 | |
| Recruiting | |
| Middleburg Heights, Ohio, United States, 44130 | |
| United States, Pennsylvania | |
| Recruiting | |
| Conshohoken, Pennsylvania, United States, 19428 | |
| Recruiting | |
| Phoenixville, Pennsylvania, United States, 19460 | |
| United States, Texas | |
| Recruiting | |
| Bedford, Texas, United States, 76021 | |
| Recruiting | |
| DeSoto, Texas, United States, 75115 | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
| Recruiting | |
| Houston, Texas, United States, 77008 | |
| Recruiting | |
| Irving, Texas, United States, 75062 | |
| Not yet recruiting | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Not yet recruiting | |
| Richland, Washington, United States, 99352 | |
| Puerto Rico | |
| Recruiting | |
| Caguas, Puerto Rico, 00725 | |
Sponsors and Collaborators
Neurocrine Biosciences
Investigators
| Study Director: | Chris O'Brien, MD | Neurocrine Biosciences |
More Information
Additional Information:
No publications provided
| Responsible Party: | Neurocrine Biosciences |
| ClinicalTrials.gov Identifier: | NCT01733121 History of Changes |
| Other Study ID Numbers: | NBI-98854-1202 |
| Study First Received: | November 20, 2012 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 May 19, 2013