NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
NCT01393600 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2017-08-10
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.
Conditions
- Tardive Dyskinesia
Interventions
- DRUG
-
NBI-98854
12.5 mg powder in bottle once daily for 14 days
- DRUG
-
NBI-98854
50 mg powder in bottle once daily for 14 days
- DRUG
-
Solution containing no active substance
Sponsors & Collaborators
-
Neurocrine Biosciences
lead INDUSTRY
Principal Investigators
-
Christopher O'Brien, MD · Neurocrine Biosciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2012-02-29
- Completion
- 2012-02-29
Countries
- United States
Study Locations
More Related Trials
-
A Study in Schizophrenia Patients
NCT01086748 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia
NCT00917293 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
NCT01955564 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
NCT01192867 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia
NCT01299389 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone
NCT02019329 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia
NCT02418819 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
NCT02855411 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
NCT01104766 ·Status: COMPLETED ·Phase: PHASE3
-
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable Schizophrenia
NCT07344948 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
NCT00921804 ·Status: COMPLETED ·Phase: PHASE2
-
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
NCT02287584 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
NCT03593213 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia
NCT00210548 ·Status: COMPLETED ·Phase: PHASE3
-
An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)
NCT03055338 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers
NCT01511510 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Lu 31-130 in Patients With Schizophrenia
NCT00770744 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia
NCT01051531 ·Status: COMPLETED ·Phase: PHASE3
-
The Effect of JNJ-39393406 on Event Related Potentials in Stable Schizophrenic Patients
NCT01137799 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
NCT01149655 ·Status: COMPLETED ·Phase: PHASE3
-
A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study
NCT00567710 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder
NCT00892125 ·Status: COMPLETED ·Phase: PHASE1
-
Schizophrenia Study In Adults
NCT00049946 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
NCT02109562 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
NCT01412060 ·Status: COMPLETED ·Phase: PHASE3