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Safety and Efficacy Study of NBI-98854 in Children and Adolescents 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: NCT02679079
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

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 6 weeks of treatment. This study will enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette Syndrome.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 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 Pediatric Subjects With Tourette Syndrome
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arm Intervention/treatment
Placebo Comparator: Placebo
Administered once daily for 6 weeks
Drug: Placebo
Experimental: Dose Group 1
Administered once daily for 6 weeks
Drug: NBI-98854
Experimental: Dose Group 2
Administered once daily for 6 weeks
Drug: NBI-98854



Primary Outcome Measures :
  1. Severity of tic symptoms assessed by Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Measurement of body areas affected, frequency and severity of motor and phonic tics assessed by modified Rush Video-based Tic Rating Scale (RTRS) [ Time Frame: Week 6 ]
  2. Premonitory Urge for Tics Scale (PUTS) [ Time Frame: Week 6 ]
  3. Overall severity and improvement of Tourette Syndrome with Clinical Global Impression-Tourette Syndrome (CGI-TS) [ Time Frame: Week 6 ]


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:   6 Years to 17 Years   (Child)
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. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids 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 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 blood loss ≥250 mL or donated blood within 30 days prior to screening
  7. Have a known history of substance dependence, substance (drug) or alcohol abuse
  8. Have a significant risk of suicidal or violent behavior
  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

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): NCT02679079


Locations
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United States, Arizona
Sun City, Arizona, United States
United States, Arkansas
Springdale, Arkansas, United States
United States, California
Long Beach, California, United States
San Bernardino, California, United States
San Diego, California, United States
Upland, California, United States
United States, Florida
Bradenton, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Loxahatchee Groves, Florida, United States
Melbourne, Florida, United States
Orlando, 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
Naperville, Illinois, United States
United States, Kansas
Wichita, Kansas, United States
United States, Massachusetts
Boston, Massachusetts, United States
Natick, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Bloomfield Hills, Michigan, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New Hampshire
Nashua, New Hampshire, United States
United States, New Jersey
Marlton, New Jersey, United States
Summit, New Jersey, United States
United States, New York
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Tennessee
Franklin, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
DeSoto, Texas, United States
Fort Worth, Texas, United States
Houston, 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
Seattle, Washington, United States
Spokane, Washington, United States
Sponsors and Collaborators
Neurocrine Biosciences
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02679079    
Other Study ID Numbers: NBI-98854-1501
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
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