Trial · NCT06771323
Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
NCT06771323, Phase 2, Recruiting, Virginia Commonwealth University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia. Trials, record NCT06771323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06771323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of Valbenazine as Adjunct Therapy to Botulinum Toxin Injections in Cervical Dystonia
- NCT number
- NCT06771323
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Cervical Dystonia
- Interventions
- Valbenazine, Placebo
- First posted
- 2025-01-13
- Last updated
- 2026-06-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Toronto Western Spasmodic Torticollis Rating Scale-2 (TWSTRS)-severity score change at 12 weeks of treatment | baseline and 12 weeks of treatment | TWSTRS-2-severity score change at 12 weeks of treatment. The isolated TWSTRS-2-Severity score change was chosen as the primary outcome because the TWSTRS-2-Severity had items dropped from the original TWSTRS as they failed to meet criteria for utility in clinimetric testing,11 and because the primary effect of Valbenazine is expected to be on the motor symptoms and less on pain and disability. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-2) uses the following scoring system for severity: 0: Absent, 1: Mild, which is less than one-third of the possible range and can be intermittent or constant 2: Moderate, which is one-third to two-thirds of the possible range and constant, or severe, which is more than two-thirds of the possible range and intermittent, and 3: Severe and constant |
| Secondary | Global Dystonia Severity Rating Scale (GDSRS) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | Pain in Dystonia Scale (PIDS), The GDS is a Likert type scale with ratings from 0 to 10 (0 is no dystonia, 1 minimal, 5 moderate and 10 severe dystonia). There are no modifying ratings or weighting factors in the GDS. The total score is the sum of the scores for all the body areas. The maximal total score of the GDS is 140. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | It comprises 14 items (7 items each for anxiety and depression), with a score ranging between 0 and 21 for the anxiety and depression subscales. For each subscale the total score is at most 21. A score of ≥11 is considered a clinically significant disorder, whereas a score between 8 and 10 suggests a mild disorder. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances. Developers have suggested a cut- off score of 5 for the global scale as it correctly identified 88.5% of the patient group in their validation study. |
| Secondary | Epworth Sleepiness Scale (ESS) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | The ESS is a short, self-administered questionnaire designed to measure sleep propensity in a simple, standardized way (only 8 questions on a total scale of 0 to 24). |
| Secondary | Cervical Dystonia Impact Profile - 58 item (CDIP-58) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | A Cervical Dystonia Impact Profile-58 (CDIP-58) score represents a patient's self-reported assessment of how much their cervical dystonia impacts their quality of life, with a higher score indicating a greater negative impact across various aspects like pain, movement limitations, sleep disturbances, mood, and social functioning; essentially, a higher score means a more significant impact from their cervical dystonia. The score is calculated from 58 questions, each rated on a scale, resulting in a total score between 0 (no impact) and 100 (severe impact). |
| Secondary | Clinical Global Impression of Severity scale (CGI-S) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | The Clinical Global Impression Scale-Severity (CGI-S) is a 7-point categorical scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.The CGI-Severity (CGI-S) asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4: Moderately ill 5: Markedly ill 6: Severely ill 7: Among the most extremely ill patients |
| Secondary | Patient Global Impression of Severity scale (PGI-S) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | The Patient Global Impression of Severity (PGI-S) scale is a single-item, 6-point, self-administered tool and is used to assess health severity in both health economics evaluation and as an outcome measure in clinical trials in a range of diseases.The highest achievable stage in PGI is Level I, which is for scores 951-1000. In between, an equal width of 50 points has been kept for each Level. In the PGI, Level II means PGI score 901-950, Level III: 851-900, Level IV: 801-850, and so on up to Level IX: 551-600. |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool that. evaluates suicidal ideation and behavior. The scale includes 4 dimensions: hopelessness, suicidal ideation, negative self-evaluation, and hostility. Each of the sub dimensions receives a total score and the sum of all scores gives the overall suicide probability score. Total scores that can be obtained from the scale range from 36 to 144 |
| Secondary | Pain in Dystonia Scale (PIDS) | Visit 2 (Baseline, Week 1) and Visit 3 (Week 6) | PIDS offers practicality featuring self-rating of pain intensity using a visual analogue scale, evaluation of pain across body regions, assessment of pain's impact on daily activities, and consideration of external factors that trigger or alleviate pain.The Scale is a 5-point, criterion-based, ordinal scale designed to assess dystonia in eight body regions: eyes, mouth, neck, trunk, and the four extremities (see Appendix I). Raters score dystonia as none (0), slight (1), mild (2), moderate (3), or severe (4). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06771323
GET https://conductscience.org/api/trials/v1/NCT06771323/registered