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Tardive DyskinesiaPhase 2NCT01733121

NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia

A Phase 2 study testing NBI-98854 in people with Tardive Dyskinesia, run by Neurocrine Biosciences at 22 sites in 2 countries.

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 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Tardive Dyskinesia
What is being tested?
NBI-98854
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
22 sitesin 2 countries
Study dates
Dec 2012to Dec 2013
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

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.
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  • 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

22 sites in 2 countries.

22 sites in 2 countries

United States21 sites

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Beachwood, Ohio, 44122

  • Study site

    Bedford, Texas, 76021

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Chicago, Illinois, 60640

  • Study site

    Conshohocken, Pennsylvania, 19428

  • Study site

    Costa Mesa, California, 92626

  • Study site

    DeSoto, Texas, 75115

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Farmington Hills, Michigan, 48334

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Houston, Texas, 77008

  • Study site

    Houston, Texas, 77030

  • Study site

    Irving, Texas, 75062

  • Study site

    Miami, Florida, 33125

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Oceanside, California, 92056

  • Study site

    Phoenixville, Pennsylvania, 19460

  • Study site

    Richland, Washington, 99352

  • Study site

    San Antonio, Texas, 78229

Other trials in United States

Puerto Rico1 site

  • Study site

    Caguas, 00725

Other trials in Puerto Rico

About this study

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

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.

Read the 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

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

    25 mg capsule

  • NBI-98854Drug

    50 mg capsule

  • PlaceboDrug

Study groups in NCT01733121
Study groupRoleWhat they receive
NBI-98854ExperimentalDose 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.
Receives: Drug: NBI-98854
PlaceboPlacebo comparatorCapsule containing no active substance, manufactured to mimic NBI-98854 25 mg and 50 mg capsules.
Receives: Drug: Placebo

What is being measured

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

  1. Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6

    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: Baseline and Week 6

Secondary outcomes (2)

  1. Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6

    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: Week 6

  2. AIMS Dyskinesia Total Score Change From Baseline at Week 6

    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: Week 6

Timeline

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

  1. First posted26 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01733121
Sponsor's protocol ID
NBI-98854-1202
Status last verified
Jul 2017
First submitted
20 Nov 2012
Last updated
10 Aug 2017
Data monitoring committee
No

Publications

  • Sajatovic M, Alexopoulos GS, Burke J, Farahmand K, Siegert S. The effects of valbenazine on tardive dyskinesia in older and younger patients. Int J Geriatr Psychiatry. 2020 Jan;35(1):69-79. doi: 10.1002/gps.5218. Epub 2019 Oct 31.

    PubMed 31617235

  • Grigoriadis DE, Smith E, Hoare SRJ, Madan A, Bozigian H. Pharmacologic Characterization of Valbenazine (NBI-98854) and Its Metabolites. J Pharmacol Exp Ther. 2017 Jun;361(3):454-461. doi: 10.1124/jpet.116.239160. Epub 2017 Apr 12.

    PubMed 28404690

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 22 sites in 2 countries.

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 22 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 Change From Baseline at Week 6 (time frame: Baseline and Week 6). 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 NCT01733121, which also lists 2 linked publications.

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.

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