The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

Neurocrine Biosciences

Status and phase: Completed; Phase 4

Conditions: Tardive Dyskinesia (TD)

Treatments: Drug: Placebo oral capsule; Drug: Valbenazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03698331

NBI-98854-TD4001

Details and patient eligibility

About

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects of childbearing potential 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.
2. Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
4. Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
5. Be in general good health.
6. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion criteria

1. Have an active, clinically significant unstable medical condition within 1 month before screening.
2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
3. Have a significant risk of suicidal or violent behavior.
4. Have a known history of neuroleptic malignant syndrome.
5. Have a known history of long QT syndrome or cardiac arrhythmia.
6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
7. Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine clinical study.
8. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
9. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
10. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
11. Are currently pregnant or breastfeeding.
12. Have HIV or hepatitis B.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

89 participants in 2 patient groups, including a placebo group

Valbenazine

Experimental group

Description:

Valbenazine or placebo oral capsules administered once daily for 7 weeks.

Treatment:

Drug: Valbenazine

Drug: Placebo oral capsule

Placebo

Placebo Comparator group

Description:

Placebo oral capsules administered once daily for 7 weeks.

Treatment:

Drug: Placebo oral capsule