Comparison · NCT03813238-00082606
TEV-50717 vs Placebo: Number of Participants With PGI-I Response
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. TEV-50717 vs Placebo: Number of Participants With PGI-I Response. Trial comparisons, record NCT03813238-00082606. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03813238-00082606
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.581 | 0.408 | 0.736 | wilson | |
| Risk in group 2 | 0.45 | 0.258 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0.131 | -0.14 | 0.377 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.73 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 1.69 | 0.545 | 5.26 | log | |
| Number needed to treat, for one more participant with the outcome on TEV-50717 than on Placebo | 7.65 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | TEV-50717 | TEV-50717 administered as oral tablets once daily for up to 15 weeks (7 weeks dose titration and 8 weeks maintenance). From Week 1 through Week 7, the dose of TEV-50717 was adjusted according to the titrations scheme (based on body weight and CYP2D6 impairment status at baseline) to identify a dose level that optimally reduced dyskinesia (as determined by the investigator, as indicated by a reduction in the ClinRO of the assessment of the CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 8 weeks. | 18 | 31 | OG001 |
| Group 2 | Placebo | Placebo administered as oral tablets once daily for up to 15 weeks. | 9 | 20 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With PGI-I Response
- Description
PGI-I response was defined as participants who were described as Much Improved or Somewhat Improved in the PGI-I score. The PGI-I is single item questionnaire to assess the participant's impression of improvement in dyskinesia symptoms after initiating therapy. The scale is a participant-reported outcome that aims to evaluate all aspects of participants' health and determine if there has been an overall improvement or not in dyskinesia symptoms. The participant selected the 1 response from the visual response options (emojis) that gave the most accurate description of his/her state of health and overall status: 1=much improved (since the initiation of treatment); 2=somewhat improved; 3=no change; 4=somewhat worse; 5=much worse (since the initiation of treatment).
- Time frame
- Week 15
- Population
The mITT analysis set included all randomized participants with at least 1 postbaseline centrally read MD-CRS part II assessment. Here, overall number of participants analyzed = participants evaluable for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
- NCT number
- NCT03813238
- Phases
- PHASE3
- Conditions
- Cerebral Palsy, Dyskinetic
- Interventions
- TEV-50717, Placebo
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Results first posted
- 2023-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03813238?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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