Trial · NCT01543321
Xenazine in Late Dyskinetic Syndrome With Neuroleptics
NCT01543321, Phase 3, Completed, Centre Hospitalier Universitaire, Amiens
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Xenazine in Late Dyskinetic Syndrome With Neuroleptics. Trials, record NCT01543321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01543321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Xenazine in Late Dyskinetic Syndrome With Neuroleptics
- NCT number
- NCT01543321
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 54 participants, actual
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Conditions
- Tardive Dyskinesia
- Interventions
- Tetrabenazine, Placebo
- First posted
- 2012-03-02
- Last updated
- 2025-11-19
- Other registries' IDs
- eudract:2011-004211-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in ESRS: Extrapyramidal Symptoms Rating Scale | 10 weeks after randomization | Changes in ESRS from Baseline and V6 (10 weeks after randomization) are assessed at the end of the 10 weeks of treatment. |
| Secondary | Changes in Sub-score ESRS-II | At baseline (V1), V4 (7 weeks after V1), V6 (10 weeks after V1) and V7 (14 weeks after V1) | ESRS-II is calculated as the ESRS total score minus ESRS sub-part II (worst score=0, best score=158). The choice of this sub-score is justified because of the possibility of improving the total ESRS can be masked by the induction of parkinsonian syndrome represented by part II of the ESRS that we chose to subtract in order to achieve the ESRS 2. |
| Secondary | CGI amelioration | At baseline (V1), V4 (7 weeks after V1), V6 (10 weeks after V1) and V7 (14 weeks after V1) | Clinical Global Impression is an ordinal scale in eight categories: unevaluated = 0; much worsened = 7 |
| Secondary | Tolerance | within the 14 weeks of the patients' participation | Tolerance includes: * neurological consultation * global clinical examination: ECG (QT), BP, pulse, orthostatic hypotension, weight |
| Secondary | Changes in Quality of life | At baseline (V1), V4 (7 weeks after V1), V6 (10 weeks after V1) and V7 (14 weeks after V1) | Quality of life will be investigated with the SF36 questionnaire. |
| Secondary | AIMS improvement | At baseline (V1), V4 (7 weeks after V1), V6 (10 weeks after V1) and V7 (14 weeks after V1) | Expected reduction of dyskinesia during the study will be investigated with the Abnormal Involuntary Movement Scale (AIMS). |
| Secondary | Changes in intermediate ESRS and post-treatment ESRS | 7 weeks after randomization and 14 weeks after randomization | Changes in ESRS are assessed between baseline and the end of the titration period (7 weeks after randomization) and after the wash-out period (14 weeks after randomization). |
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/NCT01543321
GET https://conductscience.org/api/trials/v1/NCT01543321/registered