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Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

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Neurocrine Biosciences

Status and phase

Completed
Phase 2

Conditions

Tourette Syndrome

Treatments

Drug: Placebo oral capsule
Drug: Valbenazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03325010
NBI-98854-TS2003

Details and patient eligibility

About

This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.

Enrollment

127 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

127 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants received placebo (matching valbenazine) once daily for 12 weeks.
Treatment:
Drug: Placebo oral capsule
Valbenazine
Experimental group
Description:
Participants received valbenazine once daily for 12 weeks. The starting dose was 20 mg for participants \<50 kg at baseline and 40 mg for participants ≥50 kg at baseline, and could be escalated in increments of 20 mg every 2 weeks to a maximum of 60 mg for subjects \<50 kg and 80 mg for subjects ≥50 kg to achieve an optimal dose of valbenazine for each participant.
Treatment:
Drug: Valbenazine

Trial documents
2

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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