Trial · NCT04200352
A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
NCT04200352, Phase 3, Terminated, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2024-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy. Trials, record NCT04200352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04200352
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
- NCT number
- NCT04200352
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Conditions
- Cerebral Palsy, Dyskinetic
- Interventions
- TEV-50717
- First posted
- 2019-12-16
- Last updated
- 2024-04-22
- Other registries' IDs
- eudract:2019-001807-19
- Results first posted
- 2024-04-22
- Limitations and caveats
- The study was terminated early due to failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | Baseline up to Week 55 | Adverse events can include any of the following: clinically significant vital signs, ECG parameters, or laboratory parameters. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. |
| Primary | Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | Baseline to Week 54 | Participants were placed into categories for suicidal ideation or behavior and non-suicidal self-injurious behavior based on their responses to various questions. For suicidal ideation or behavior, the following categories were used: None; Wish to be dead; Non-specific active suicidal thoughts; Any methods (not plan) without intent to act; Some intent to act, without specific plan; Specific plan and intent; Preparatory acts or behavior; Aborted attempt; Interrupted attempt; Actual attempt; and Suicide. For non-suicidal self-injurious behavior, the following categories were used: No or yes. Number of participants with worst overall finding of suicidal ideation or suicidal behavior and non-suicidal self-injurious behavior from Baseline to Week 54 are reported. |
| Primary | Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score at Week 54 | Baseline, Week 54 | The ESRS subscale I is a 7-item subjective questionnaire to evaluate parkinsonism, akathisia, dystonia and dyskinesia. The ESRS I is scored on a 4-point scale (0=absent, 1=Mild, 2=Moderate, 3=Severe) for each item. The evaluation takes into account the verbal report of the participant on 1) the frequency and duration of the symptom during the day, 2) the number of days the symptom was present during the last week, and 3) the subjective evaluation of the intensity of the symptom by the participant. Total score was the sum of the 7 items which ranges from 0 (absent) to 28 (severe). Higher scores indicate greater severity of disorder. |
| Primary | Change From Baseline in ESRS Subscale II Total Score at Week 54 | Baseline, Week 54 | The ESRS subscale II is a 17-item questionnaire to evaluate parkinsonism and akathisia. The ESRS II consists of the following parts: tremor (0 \[none\]-48 \[severe\]), gait and posture (0 \[none\]-6 \[severe\]), postural stability (0 \[none\]-6 \[severe\]), rigidity (0 \[none\]-24 \[severe\]), expressive automatic movements (0 \[none\]-6 \[severe\]), bradykinesia (0 \[none\]-6 \[severe\]), and akathisia (0 \[none\]-6 \[severe\]). Total score was the sum of the 17 items ranging from 0 (absent) to 102 (severe). Higher scores indicate greater severity of disorder. |
| Primary | Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 53 | Baseline, Week 53 | The CBCL assesses behavioral and emotional status in children ages 6 through 18 years of age as reported by the caregiver. The full CBCL has two parts, a Competence Scale (Parts I to VII) and a Syndrome Scale (behavioral items). The Competence Scale (Parts I to VII) assesses various activities (for example, sports, hobbies, games, organizations, clubs, teams, groups, jobs, and chores), interpersonal relationships, and academic performance. The checklists having 120 questions consist of a number of statements about the child's behavior and responses which are recorded on a scale: 0 = Not True; 1 = Somewhat or Sometimes True; 2 = Very True or Often True. CBCL competence total score ranged from 0 (no problem) to 240 (lesser problem), which was calculated by adding individual scores of each domain. Higher scores indicate greater problems in child behavior. |
| Primary | Change From Baseline in CBCL Syndrome Total Score at Week 53 | Baseline, Week 53 | The CBCL assesses behavioral and emotional status in children ages 6 through 18 years of age as reported by the caregiver. The full CBCL has two parts, a Competence Scale (Parts I to VII) and a Syndrome Scale (behavioral items). The Syndrome Scale comprises 113 questions related to problem behaviors. For each item, the responses are recorded on a scale: 0 = Not True; 1 = Somewhat or Sometimes True; 2 = Very True or Often True. The problem behaviors are scored on the following 8 empirically based syndromes: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, and aggressive behavior. CBCL syndrome total score ranged from 0 (no problem) to 226 (lesser problem), which was calculated by adding individual scores of each domain. Higher scores indicate greater problems in child behavior. |
| Primary | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 54 | Baseline, Week 54 | The ESS is a self-administered questionnaire composed of 8 questions that provide a measure of a participant's general level of daytime sleepiness. The ESS is composed of 8 items. The responders were asked to rate their chances of falling asleep while engaged at 8 different activities, on a 4-point scale: 0 = would never fall asleep; 1=slight chance of falling asleep; 2=moderate chance of falling asleep; 3=high chance of falling asleep. Total score was calculated as the sum of 8 item scores ranging from 0 (never) to 24 (high chance of falling asleep). Higher scores indicate high chances of falling asleep. |
| Secondary | Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part I Total Score (General Assessment, Centrally Read) | Baseline, Week 53, Week 54 | The MD-CRS part I evaluates the impact of dyskinesia in cerebral palsy (DCP) on the activities of the participant and provides a general assessment of the movement disorder of motor function (7 items), oral/verbal function (3 items), self-care (3 items), and attention/alertness (2 items) on a scale of 0 (present) to 4 (absent). All items were scored by the rater in the clinic and were centrally read based on video recording. The total score was obtained by summing the individual items' scores and ranges from 0 (marked/prolonged disorder) to 60 (absent of a disorder), with higher scores indicating lesser disorder. |
| Secondary | Change From Baseline in the MD-CRS Part II Total Score (Movement Disorder Severity, Centrally Read) | Baseline, Week 53, Week 54 | MD-CRS part II evaluates the severity of movement disorder on a scale of 0 to 4 in 7 body regions, all areas in which dyskinesia can be seen. All items were scored by the rater in the clinic and were centrally read based on video recording. In rating the movement disorder of a body part, 0 refers to absence of a movement disorder and 4 refers to a situation where movement disorder is present during all of the tasks for the region examined and/or involves 3 or more of the other regions, making completion impossible. The 7 body regions are (i) eye and periorbital region, (ii) face, (iii) tongue and perioral region, (iv) neck, (v) trunk, (vi) upper limb, and (vii) lower limb. Total score was obtained by summing the individual items scores and ranges from 0 (absent of a movement disorder) to 28 (marked/prolonged movement disorder), with higher scores indicating more movement disorder. |
| Secondary | Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) | Baseline, Week 53, Week 54 | The MD-CRS part I evaluates the impact of DCP on the activities of the participant and provides a general assessment of the movement disorder of motor function (7 items), oral/verbal function (3 items), self-care (3 items), and attention/alertness (2 items) on a scale of 0 (present) to 4 (absent). All items were scored by the investigational center physician. The total score was obtained by summing the individual items' scores and ranges from 0 (marked/prolonged movement disorder) to 60 (absent of a movement disorder), with higher scores indicating lesser movement disorder. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | Baseline up to Week 55 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | Baseline to Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants who provided a baseline value and at least one post-baseline value for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in ESRS Subscale II Total Score at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in CBCL Syndrome Total Score at Week 53 | Baseline, Week 53 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 54 | Baseline, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part I Total Score (General Assessment, Centrally Read) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part II Total Score (Movement Disorder Severity, Centrally Read) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) | Baseline, Week 53, Week 54 | The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | units on a scale | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | TEV-50717 | 39 | Participants | ||
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - None | 18 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Wish to be dead | 0 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Non-specific active suicidal thoughts | 0 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Any methods (not plan) without intent to act | 0 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Some intent to act, without specific plan | 0 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Specific plan and intent | 0 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Preparatory acts or behavior | 0 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Aborted attempt | 0 | Participants | |
| Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) | TEV-50717 | Suicidal ideation/behavior - Interrupted attempt | 0 | Participants |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TEV-50717 | 44 | |
| Overall Study | Received at Least 1 Dose of Study Drug | TEV-50717 | 44 | |
| Overall Study | COMPLETED | TEV-50717 | 24 | |
| Overall Study | NOT COMPLETED | TEV-50717 | 20 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | TEV-50717 | 3 | 44 | 6 |
| other | Constipation | Gastrointestinal disorders | TEV-50717 | 3 | 44 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | TEV-50717 | 4 | 44 | 4 |
| other | Vomiting | Gastrointestinal disorders | TEV-50717 | 4 | 44 | 4 |
| other | Fatigue | General disorders | TEV-50717 | 3 | 44 | 3 |
| other | Pyrexia | General disorders | TEV-50717 | 3 | 44 | 5 |
| other | COVID-19 | Infections and infestations | TEV-50717 | 4 | 44 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | TEV-50717 | 3 | 44 | 3 |
| other | Akathisia | Nervous system disorders | TEV-50717 | 3 | 44 | 4 |
| other | Dystonia | Nervous system disorders | TEV-50717 | 3 | 44 | 7 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TEV-50717 | 1 | 44 |
| Total, other adverse events | TEV-50717 | 33 | 44 |
| Total, serious adverse events | TEV-50717 | 1 | 44 |
Source ClinicalTrials.gov
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/NCT04200352
GET https://conductscience.org/api/trials/v1/NCT04200352/registered?page=2