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Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT02879578
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief Summary:
Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arm Intervention/treatment
Experimental: NBI-98854
NBI-98854 administered once daily for up to 24 weeks
Drug: NBI-98854



Primary Outcome Measures :
  1. Frequency of treatment-emergent adverse events [Safety and Tolerability] [ Time Frame: Up to 24 Weeks ]

Secondary Outcome Measures :
  1. Severity of tics assessed by modified Rush Video-based Tic Rating Scale [ Time Frame: Week 24 ]
  2. Premonitory Urge for Tics Scale (PUTS) [ Time Frame: Week 24 ]
  3. Overall severity of Tourette Syndrome assessed by Clinical Global Impression-Tics Severity (CGI-TS) [ Time Frame: Week 24 ]
  4. Pediatric Quality of Life Inventory [PedsQL] for pediatric subjects [Health-related quality of life] [ Time Frame: Week 24 ]
  5. Gilles de la Tourette syndrome - Quality of Life scale [GTS QOL] for adult subjects [Health-related quality of life] [ Time Frame: Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have participated in and completed the NBI-98854-1501 (T-Force Green) or NBI-98854-1505 (T-Forward) Phase 2 study
  • Have a clinical diagnosis of Tourette Syndrome (TS)
  • 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
  • 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
  • Adolescent and adult subjects (12 to 64 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen. Subjects who are on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates, or psychostimulants (for subjects with comorbid ADHD) are allowed to participate in the study
  • Be in good general health

Exclusion Criteria:

  • Have an active, clinically significant unstable medical condition within 1 month prior to screening
  • Have a known history of long QT syndrome or cardiac arrhythmia
  • Have a known history of neuroleptic malignant syndrome
  • Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
  • Have a blood loss ≥250 mL or donated blood within 56 days prior to screening (subjects 6 to 17 years of age); have a blood loss ≥550 mL or donated blood within 30 days prior to screening (subjects 18 to 64 years of age)
  • Have a known history of substance dependence, substance (drug) or alcohol abuse
  • Have a significant risk of suicidal or violent behavior
  • Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the screening period or at baseline or plan to initiate CBIT during the study
  • 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): NCT02879578


Locations
United States, Arizona
Sun City, Arizona, United States
United States, California
San Diego, California, United States
United States, Florida
Loxahatchee Groves, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
United States, Illinois
Naperville, Illinois, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New Jersey
Summit, New Jersey, United States
United States, New York
New York, New York, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Fort Worth, Texas, United States
United States, Washington
Spokane, Washington, United States
Sponsors and Collaborators
Neurocrine Biosciences

Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02879578     History of Changes
Other Study ID Numbers: NBI-98854-1601
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Syndrome
Tourette 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
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs