Tardive DyskinesiaPhase 2NCT01393600

NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

A Phase 2 study testing NBI-98854 in people with Tardive Dyskinesia, run by Neurocrine Biosciences at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Tardive Dyskinesia
What is being tested?: NBI-98854
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 11 sitesUnited States
Study dates: Aug 2011to Feb 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), 333.82 (see Appendix 17.1) 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.

Show all 10Show fewer

Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
Woodland International Research Group, Inc
Little Rock, Arkansas, 72211
San Marcus Research Clinic, Inc.
Miami, Florida, 33015
Medical Research Marseilles
Miami, Florida, 33155
Synergy Clinical Research
National City, California, 91950
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
UCSD Outpatient Psychiatry
San Diego, California, 92103
PCSD - Feighner Research
San Diego, California, 92108
St. Louis Clinical Trials
St Louis, Missouri, 63118

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Period Cross-Over Study to Evaluate the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

Conditions: Tardive Dyskinesia
Being tested: NBI-98854, Placebo
Medical subject headings: Tardive Dyskinesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NBI-98854Drug
12.5 mg powder in bottle once daily for 14 days
NBI-98854Drug
50 mg powder in bottle once daily for 14 days
PlaceboDrug
Solution containing no active substance

Study groups in NCT01393600
Study group	Role	What they receive
NBI-98854 12.5 mg	Experimental	During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences: Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28. Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28. Receives: Drug: NBI-98854; Drug: Placebo
NBI-98854 50 mg	Experimental	During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences: Sequence 3: Placebo once daily dose for Days 1-14 and 50 mg NBI-98854 once daily dose for Days 15-28. Sequence 4: 50 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28. Receives: Drug: NBI-98854; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Measured: Day 15 and 29, averaged

Secondary outcomes (1)

Clinical Global Impression - Global Improvement of TD (CGI-TD)
Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Measured: Day 15 and 29, averaged

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Feb 2012

First posted13 Jul 2011 (estimated)
Study startAug 2011
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01393600
Sponsor's protocol ID: NBI-98854-1101
Status last verified: Jul 2017
First submitted: 11 Jul 2011
Last updated: 10 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
RecruitingPhase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Tardive Dyskinesia, Intellectual Disability
RecruitingPhase 2
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive Dyskinesia
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation

All Tardive Dyskinesia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Period Cross-Over Study to Evaluate the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
ClinicalTrials.gov ID: NCT01393600
Acronym / sponsor ID: NBI-98854-1101
Conditions: Tardive Dyskinesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Neurocrine BiosciencesIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 13 Jul 2011 (estimated)
Results: Posted 10 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
NBI-98854 12.5 mg	Experimental	Drug: NBI-98854, Drug: PlaceboDuring the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences: Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28. Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.
NBI-98854 50 mg	Experimental	Drug: NBI-98854, Drug: PlaceboDuring the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences: Sequence 3: Placebo once daily dose for Days 1-14 and 50 mg NBI-98854 once daily dose for Days 15-28. Sequence 4: 50 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), 333.82 (see Appendix 17.1) 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.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NBI-9885412.5 mg powder in bottle once daily for 14 days	Drug	NBI-98854 12.5 mg
NBI-9885450 mg powder in bottle once daily for 14 days	Drug	NBI-98854 50 mg
PlaceboSolution containing no active substance	Drug	NBI-98854 12.5 mg, NBI-98854 50 mg

Primary outcome

Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Time frame: Day 15 and 29, averaged
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

1 secondary outcome

Clinical Global Impression - Global Improvement of TD (CGI-TD)
Time frame: Day 15 and 29, averaged

Results and safety

Results posted to the registry on 10 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Then Valbenazine 12.5 mg	9	9
Valbenazine 12.5 mg, Then Placebo	8	7
Placebo, Then Valbenazine 50 mg	10	9
Valbenazine 50 mg, Then Placebo	10	9

Primary outcome: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score

Time frame: Day 15 and 29, averaged. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 33	Valbenazine 12.5 mg n = 17	Valbenazine 50 mg n = 15
Value	9.9 (0.7)	9.1 (1.2)	8.8 (1.2)

Placebo vs Valbenazine 12.5 mg: Mean Difference (Final Values): -0.7 (95% CI -3.3 to 1.9), p = 0.5880, ANOVA
Placebo vs Valbenazine 50 mg: Mean Difference (Final Values): -1.1 (95% CI -3.8 to 1.6), p = 0.4184, ANOVA

Population analysed: Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 35 (0%)	4 of 35 (11.4%)	0 of 35
NBI-98854 12.5 mg	1 of 17 (5.9%)	4 of 17 (23.5%)	0 of 17
NBI-98854 50 mg	0 of 19 (0%)	6 of 19 (31.6%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tardive Dyskinesia

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
RecruitingPhase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Tardive Dyskinesia, Intellectual Disability
RecruitingPhase 2
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive Dyskinesia
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher O'Brien, MD study director

Neurocrine Biosciences

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NBI-98854 in people with Tardive Dyskinesia, run by Neurocrine Biosciences at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (time frame: Day 15 and 29, averaged). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01393600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.