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Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581865
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Study Description
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Brief Summary:
Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Drug: NBI-98854 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo administered once daily for 8 weeks
 Drug: Placebo
Experimental: Dose Group 1
Fixed dose administered once daily for 8 weeks
 Drug: NBI-98854
Experimental: Dose Group 2
Fixed dose administered once daily for 8 weeks
 Drug: NBI-98854


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to Week 8 in the YGTSS TTS [ Time Frame: Baseline, Week 8 ]
    The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The YGTSS was administered by the investigator (or qualified designee) using a computer-based structured clinical interview. The TTS is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity


Secondary Outcome Measures :
  1. Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8 [ Time Frame: Week 8 ]
    The CGI-TS-Improvement scale is used to assess overall improvement since the initiation of study drug dosing on a 7-point scale. Each of the CGI-TS-Improvement response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.

  2. Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score [ Time Frame: Baseline, Week 8 ]
    The CGI-Tics-Severity scale is used to assess overall severity on a 7-point scale. Each of the CGI-Tics-Severity response categories was assigned a numerical score as follows: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patient.

  3. Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score [ Time Frame: Baseline, Week 8 ]
    A modified RTRS was used in this study that includes short video recordings to measure 5 tic variables: number of body areas affected, frequency of motor and phonic tics, and severity of motor and phonic tics. The RTRS total score is calculated as the sum of the 5 domain scores, and ranges from 0 to 20, with higher scores representing greater severity. The final on-treatment visit was used in subjects who discontinued prior to Week 8.

  4. Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score [ Time Frame: Baseline, Week 8 ]
    The YGTSS Global Tic Severity score is the sum of the YGTSS TTS and the YGTSS Impairment score and ranges from 0 to 100, with higher scores representing greater severity.

  5. Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score [ Time Frame: Baseline, Week 8 ]
    The PUTS is an instrument for quantifying the premonitory urge phenomena associated with tics. It consists of 9 items, each of which is scored on a 4-point scale (1=not at all true, 2=a little true, 3=pretty much true, 4=very much true). The PUTS total score is calculated as the sum of the scores for the 9 items. The maximum possible total score is 36.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a clinical diagnosis of Tourette Syndrome (TS)
  2. Have at least moderate tic severity
  3. Have TS symptoms that impair school, occupational, and/or social function
  4. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
  5. Be in good general health
  6. Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen
  7. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:

  1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
  2. Have a known history of long QT syndrome or cardiac tachy-arrhythmia
  3. Have a known history of neuroleptic malignant syndrome
  4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
  5. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
  6. Have a known history of substance dependence, substance (drug) or alcohol abuse
  7. Have a significant risk of suicidal or violent behavior
  8. Are currently pregnant or breastfeeding
  9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
  10. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
  11. Have a blood loss ≥550 mL or donated blood within 30 days prior to screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581865


Locations
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United States, California
Long Beach, California, United States
National City, California, United States
San Bernardino, California, United States
San Diego, California, United States
Upland, California, United States
United States, Florida
Gainesville, Florida, United States
Hialeah, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
Natick, Massachusetts, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, New Hampshire
Nashua, New Hampshire, United States
United States, New Jersey
Summit, New Jersey, United States
United States, New York
Albany, New York, United States
Manhasset, New York, United States
New York, New York, United States
Staten Island, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Irving, Texas, United States
United States, Utah
Orem, Utah, United States
Salt Lake City, Utah, United States
United States, Washington
Kirkland, Washington, United States
Spokane, Washington, United States
Sponsors and Collaborators
Neurocrine Biosciences
  Study Documents (Full-Text)

Documents provided by Neurocrine Biosciences:
Study Protocol  [PDF] June 29, 2016
Statistical Analysis Plan  [PDF] December 14, 2016

More Information
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02581865    
Other Study ID Numbers: NBI-98854-1505
First Posted: October 21, 2015    Key Record Dates
Results First Posted: May 7, 2020
Last Update Posted: May 7, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Tourette Syndrome
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders