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

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ClinicalTrials.gov Identifier: NCT02581865
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : February 21, 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 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 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 : October 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

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



Primary Outcome Measures :
  1. Severity of tic symptoms assessed by Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Week 8 ]

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 8 ]
  2. Premonitory Urge for Tics Scale (PUTS) [ Time Frame: Week 8 ]
  3. Overall severity and improvement of Tourette Syndrome with Clinical Global Impression of Change-Tourette Syndrome (CGI-TS) [ Time Frame: Week 8 ]


Information from the National Library of Medicine

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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

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


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Sponsors and Collaborators
Neurocrine Biosciences

Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02581865     History of Changes
Other Study ID Numbers: NBI-98854-1505
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

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