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

• ClinicalTrials.gov Identifier: NCT02736955
• Recruitment Status: Completed
• First Posted: April 13, 2016
• Results First Posted: December 19, 2018
• Last Update Posted: December 19, 2018
• Sponsor: Neurocrine Biosciences
• Information provided by (Responsible Party): Neurocrine Biosciences

Tracking Information

• First Submitted Date: April 8, 2016
• First Posted Date: April 13, 2016
• Results First Submitted Date: October 10, 2018
• Results First Posted Date: December 19, 2018
• Last Update Posted Date: December 19, 2018
• Actual Study Start Date: June 13, 2016
• Actual Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2018)

Number of Participants Monitored for Long-term Safety of Valbenazine [ Time Frame: 60 weeks ]

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.

• Original Primary Outcome Measures (submitted: April 12, 2016): Safety and tolerability measurements (incidence and types of adverse events, physical examination, laboratory tests) [ Time Frame: Up to 72 weeks ]

Current Secondary Outcome Measures (submitted: November 28, 2018)

• Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale [ Time Frame: Baseline and Weeks 12, 24, 36, 48, and 60 ]
  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."
• Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ) [ Time Frame: Baseline and Weeks 12, 24, 36, 48, and 60 ]
  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."

Original Secondary Outcome Measures (submitted: April 12, 2016)

• Clinical Global Impression - Global Improvement of Tardive Dyskinesia - Severity (CGI-TD-Severity) [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]
• Patient Satisfaction Questionnaire [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]
• Social Functioning Scale (SFS) [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Tardive Dyskinesia

Intervention

Drug: Valbenazine

Other Name: NBI-98854

Study Arms

Experimental: Valbenazine

Fixed dose of valbenazine administered once daily for up to 72 weeks

Intervention: Drug: Valbenazine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 28, 2018): 161
• Original Estimated Enrollment (submitted: April 12, 2016): 75
• Actual Study Completion Date: June 30, 2017
• Actual Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02736955
• Other Study ID Numbers: NBI-98854-1506
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Neurocrine Biosciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Neurocrine Biosciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Neurocrine Biosciences
• Verification Date: November 2018