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The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Phase 4 trial testing Valbenazine in Tardive Dyskinesia (TD) in 89 participants. Completed in 3 April 2019.
| Lead sponsor | Neurocrine Biosciences |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 14 September 2018 |
| Primary completion | 3 April 2019 |
| Estimated completion | 3 April 2019 |
| Sites | 17 locations across Puerto Rico, United States |
Neurocrine Biosciences — full company profile →
Adults 18 to 65, any sex, with Tardive Dyskinesia (TD). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A withdrawal-emergent adverse event is an adverse event that begins during the Withdrawal Period.
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 9 | |
| Placebo/Placebo | 13 |
The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Worsening of symptoms is defined by 5 new symptoms of moderate or severe degree or a worsening of symptoms by 2 points on the PWC-20 scale during Weeks 5 to 7 compared with Week 4. Note: a 2-point worsening from 0 (none) at Week 4 to 2 (moderate) post-Week 4 is counted as a worsening of symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 9 | |
| Placebo/Placebo | 3 |
The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Larger values indicate more severe symptoms. Rickels et al (J Clin Psychopharmacol 2008) cites PWC-20 mean scores associated with withdrawal in the range of 15 to 24.
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 4.6 | ± 5.0 |
| Placebo/Placebo | 3.9 | ± 4.5 |
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 3.8 | ± 3.7 |
| Placebo/Placebo | 3.1 | ± 3.8 |
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 5.6 | ± 5.3 |
| Placebo/Placebo | 3.3 | ± 2.6 |
The mCSSA is an 18-item survey based on symptoms commonly associated with early cocaine abstinence, including depression, fatigue, anhedonia, anxiety, irritability, sleep disturbance, and inability to concentrate. Items are rated on scales of 0 to 7 or 0 to 8, with separate scale descriptions for each item. Larger values indicate more severe symptoms. The scale has been modified to be specific to study drug (valbenazine or placebo) instead of cocaine.
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 1.9 | ± 4.1 |
| Placebo/Placebo | 0.5 | ± 3.2 |
The CGI-TD-I scale is a 7-point scale (range; 1=very much improved to 7=very much worse) used to assess overall improvement in TD symptoms since the initiation of study drug dosing.
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 3.2 | ± 0.8 |
| Placebo/Placebo | 3.4 | ± 0.7 |
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | 3.0 | ± 0.7 |
| Placebo/Placebo | 3.0 | ± 0.8 |
The CGI-TD-S scale is a 7-point scale (range; 1=normal, not at all ill to 7=among the most extremely ill patient) used to assess the overall global severity of TD.
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | -0.3 | ± 0.7 |
| Placebo/Placebo | -0.2 | ± 0.6 |
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | -0.3 | ± 0.6 |
| Placebo/Placebo | -0.3 | ± 0.6 |
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | -0.4 | ± 0.5 |
| Placebo/Placebo | -0.5 | ± 0.6 |
| Group | Value | 95% CI |
|---|---|---|
| Valbenazine/Placebo | -0.4 | ± 0.5 |
| Placebo/Placebo | -0.5 | ± 0.6 |
Time frame: Up to 7 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Valbenazine/Placebo | Placebo/Placebo |
|---|---|---|---|
| Schizoaffective disorder | Psychiatric disorders | — | — |
| Psychotic disorder | Psychiatric disorders | — | — |
| Reaction | System | Valbenazine/Placebo | Placebo/Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Salivary hypersecretion | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Dry eye | Eye disorders | — | — |
| Fatigue | General disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Hypertension | Vascular disorders | — | — |
Most-reported serious reactions: Schizoaffective disorder, Psychotic disorder.
Data from ClinicalTrials.gov NCT03698331 adverse events section.
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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