Phase 2
N=109
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
Tardive Dyskinesia
Bottom Line
View on ClinicalTrials.gov: NCT01688037 ↗Enrolled (actual)
109
Serious AEs
2.1%
Results posted
Nov 2017
Primary outcome: Primary: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6 — -2.5; -3.3 units on a scale — p=0.2966
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NBI-98854 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurocrine Biosciences
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6 |
-2.5; -3.3 | 0.2966 |
| SECONDARY Clinical Global Impression - Global Improvement of TD (CGI-TD) |
3.2; 3.3 | 0.743 |
| SECONDARY Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2 |
3.6; 3.3; 3.2 | 0.1151 |
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Eligibility Criteria
Inclusion Criteria
- Have a clinical diagnosis of schizophrenia or schizoaffective disorder and 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.
Data sourced from ClinicalTrials.gov (NCT01688037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.