Open-Label Safety and Tolerability Study 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: Valbenazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03444038
NBI-98854-TS2004

Details and patient eligibility

About

This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.

Enrollment

85 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Have participated in and completed Study NBI-98854-TS2003 2. Have a clinical diagnosis of Tourette Syndrome (TS) 3. 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 4. Be in good general health 5. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen 6. 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 vesicular monoamine transporter 2 (VMAT2) inhibitors 6. Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline 7. Have a known history of substance (drug) dependence, or substance or alcohol abuse 8. Have a significant risk of suicidal or violent behavior 9. 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

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

85 participants in 1 patient group

Valbenazine
Experimental group
Description:
Valbenazine administered once daily for up to 24 weeks
Treatment:
Drug: Valbenazine

Trial documents
2

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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