Clinical trial NCT02736955: Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Official title: Open-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tardive Dyskinesia
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Detailed description: This study was terminated after 60 weeks due to the commercial availability of valbenazine.

Eligibility criteria: Inclusion Criteria:

* Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
* Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.
* If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.
* Be in general good health.
* Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

* Have an active, clinically significant unstable medical condition within 1 month prior to screening.
* Have a known history of substance dependence, substance (drug) or alcohol abuse.
* Have a significant risk of suicidal or violent behavior.
* Have a known history of neuroleptic malignant syndrome.
* Have a known history of long QT syndrome or cardiac arrhythmia.
* Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than valbenazine) during the study.
* Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
* Are currently pregnant or breastfeeding.

Primary outcomes:
measure: Number of Participants Monitored for Long-term Safety of Valbenazine
timeFrame: 60 weeks
Secondary outcomes:
measure: Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale
timeFrame: Baseline and Weeks 12, 24, 36, 48, and 60
measure: Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)
timeFrame: Baseline and Weeks 12, 24, 36, 48, and 60
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: National City
country: United States
state: California
city: Norwalk
country: United States
state: California
city: Oakland
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Hialeah
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Worcester
country: United States
state: Massachusetts
city: Cedarhurst
country: United States
state: New York
city: Dayton
country: United States
state: Ohio
city: Shaker Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Norristown
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Franklin
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: DeSoto
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Petersburg
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
References:
citation: Lindenmayer JP, Verghese C, Marder SR, Burke J, Jimenez R, Siegert S, Liang GS, O'Brien CF. A long-term, open-label study of valbenazine for tardive dyskinesia. CNS Spectr. 2021 Aug;26(4):345-353. doi: 10.1017/S109285292000108X. Epub 2020 May 18.