CompletedPhase 4

Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

United States135 participantsStarted 2019-03-18

Plain-language summary

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
✓. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
✓. 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.
✓. Be in general good health.
✓. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

✕. Have an active, clinically significant unstable medical condition within 1 month before screening.
✕. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
✕. Have a significant risk of suicidal or violent behavior.
✕. Have been hospitalized for psychiatric disorder within 6 months before Day 1.
✕. Have a known history of neuroleptic malignant syndrome.
✕. Have a known history of long QT syndrome or cardiac arrhythmia.
✕. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
✕. Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.

Change From Randomization (Week 8) in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 16

Timeframe: Week 8, Week 16

NCT IDNCT03891862

SponsorNeurocrine Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-23

Results submitted2021-02-16

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
✓. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
✓. 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.
✓. Be in general good health.
✓. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

✕. Have an active, clinically significant unstable medical condition within 1 month before screening.
✕. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
✕. Have a significant risk of suicidal or violent behavior.
✕. Have been hospitalized for psychiatric disorder within 6 months before Day 1.
✕. Have a known history of neuroleptic malignant syndrome.
✕. Have a known history of long QT syndrome or cardiac arrhythmia.
✕. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
✕. Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.