Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Tardive Dyskinesia Clinical Trial

Official title:

Open-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736955
• Other study ID #: NBI-98854-1506
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2018
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

Intervention

Drug:
• Valbenazine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Monitored for Long-term Safety of Valbenazine	Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.	60 weeks
Secondary	Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale	Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= "Normal, not at all ill" to 7= "Among the most extremely ill patient"). A clinical response was defined as a CGI-TD-S score equal to "1" or "2."	Baseline and Weeks 12, 24, 36, 48, and 60
Secondary	Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)	Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to "1" or "2."	Baseline and Weeks 12, 24, 36, 48, and 60