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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT02679079
First received: February 5, 2016
Last updated: March 14, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Tourette Syndrome
Drug: NBI-98854
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Neurocrine Biosciences:

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

Secondary Outcome Measures:
  • 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 ]
  • Premonitory Urge for Tics Scale (PUTS) [ Time Frame: Week 6 ]
  • Overall severity and improvement of Tourette Syndrome with Clinical Global Impression-Tourette Syndrome (CGI-TS) [ Time Frame: Week 6 ]

Estimated Enrollment: 90
Study Start Date: January 2016
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02679079

  Show 44 Study Locations
Sponsors and Collaborators
Neurocrine Biosciences
  More Information

Additional Information:
Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02679079     History of Changes
Other Study ID Numbers: NBI-98854-1501
Study First Received: February 5, 2016
Last Updated: March 14, 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

ClinicalTrials.gov processed this record on April 24, 2017