Trial Outcomes & Findings for A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy (NCT NCT04200352)

NCT ID: NCT04200352

Last Updated: 2024-04-22

Results Overview

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'.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 44 participants
• Primary outcome timeframe: Baseline up to Week 55
• Results posted on: 2024-04-22

Participant Flow

A total of 44 participants with dyskinesia in cerebral palsy (DCP) from Study TV50717-CNS-30080 (NCT03813238) rolled over into Study TV50717-CNS-30081.

Participant milestones

Measure	TEV-50717 TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 cytochrome P450 2D6 \[CYP2D6\] 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 clinical global impression of improvement \[CGI-I\]) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Overall Study STARTED	44
Overall Study Received at Least 1 Dose of Study Drug	44
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	TEV-50717 TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 cytochrome P450 2D6 \[CYP2D6\] 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 clinical global impression of improvement \[CGI-I\]) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Overall Study Death	1
Overall Study Adverse Event	6
Overall Study Withdrawal by parent/guardian	6
Overall Study Lack of Efficacy	1
Overall Study Other than specified	6

Baseline Characteristics

Here, 'overall number of participants analyzed' = participants evaluable for this Baseline measure.

Baseline characteristics by cohort

Measure	TEV-50717 n=44 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Age, Continuous	11.1 years STANDARD_DEVIATION 3.56 • n=44 Participants
Sex: Female, Male Female	15 Participants n=44 Participants
Sex: Female, Male Male	29 Participants n=44 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=44 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=44 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=44 Participants
Race (NIH/OMB) Asian	0 Participants n=44 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=44 Participants
Race (NIH/OMB) Black or African American	0 Participants n=44 Participants
Race (NIH/OMB) White	42 Participants n=44 Participants
Race (NIH/OMB) More than one race	0 Participants n=44 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=44 Participants
Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score	9.7 units on a scale STANDARD_DEVIATION 3.94 • n=44 Participants
ESRS Subscale II Total Score	20.7 units on a scale STANDARD_DEVIATION 19.73 • n=44 Participants
Child Behavior Checklist (CBCL) Competence Total Score	11.70 units on a scale STANDARD_DEVIATION 4.392 • n=33 Participants • Here, 'overall number of participants analyzed' = participants evaluable for this Baseline measure.
CBCL Syndrome Total Score	30.7 units on a scale STANDARD_DEVIATION 21.06 • n=44 Participants
Epworth Sleepiness Scale (ESS) Total Score	2.0 units on a scale STANDARD_DEVIATION 2.79 • n=44 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 55

Population: The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.

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'.

Outcome measures

Measure

TEV-50717 n=44 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Number of Participants With Adverse Events (AEs)

39 Participants

PRIMARY outcome

Timeframe: Baseline to Week 54

Population: 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 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.

Outcome measures

Measure	TEV-50717 n=18 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) Suicidal ideation/behavior - None	18 Participants
Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) 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) 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) 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) 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) 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) 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) 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) Suicidal ideation/behavior - Interrupted attempt	0 Participants
Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) Suicidal ideation/behavior - Actual attempt	0 Participants
Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) Suicidal ideation/behavior - Suicide	0 Participants
Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) Non-suicidal self-injurious behavior - No	18 Participants
Number of Participants (Aged ≥12 Years) With Columbia-Suicide Severity Rating Scale (C-SSRS) Outcomes (Worst Overall Finding) Non-suicidal self-injurious behavior - Yes	0 Participants

PRIMARY outcome

Timeframe: Baseline, Week 54

Population: 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.

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.

Outcome measures

Measure

TEV-50717 n=24 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) Subscale I Total Score at Week 54

-1.4 units on a scale Standard Deviation 2.02

PRIMARY outcome

Timeframe: Baseline, Week 54

Population: 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.

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.

Outcome measures

Measure

TEV-50717 n=24 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in ESRS Subscale II Total Score at Week 54

-1.5 units on a scale Standard Deviation 6.41

PRIMARY outcome

Timeframe: Baseline, Week 53

Population: 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.

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.

Outcome measures

Measure

TEV-50717 n=20 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Child Behavior Checklist (CBCL) Competence Total Score at Week 53

0.49 units on a scale Standard Deviation 3.018

PRIMARY outcome

Timeframe: Baseline, Week 53

Population: 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.

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.

Outcome measures

Measure

TEV-50717 n=25 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in CBCL Syndrome Total Score at Week 53

-1.7 units on a scale Standard Deviation 14.96

PRIMARY outcome

Timeframe: Baseline, Week 54

Population: 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.

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.

Outcome measures

Measure

TEV-50717 n=23 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 54

0.7 units on a scale Standard Deviation 3.51

SECONDARY outcome

Timeframe: Baseline, Week 53, Week 54

Population: 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.

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.

Outcome measures

Measure	TEV-50717 n=30 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part I Total Score (General Assessment, Centrally Read) Change at Week 53	-2.41 units on a scale Standard Deviation 5.24
Change From Baseline in the Movement Disorder-Childhood Rating Scale (MD-CRS) Part I Total Score (General Assessment, Centrally Read) Change at Week 54	-1.40 units on a scale Standard Deviation 4.989

SECONDARY outcome

Timeframe: Baseline, Week 53, Week 54

Population: 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.

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.

Outcome measures

Measure	TEV-50717 n=25 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Change From Baseline in the MD-CRS Part II Total Score (Movement Disorder Severity, Centrally Read) Change at Week 53	-1.5 units on a scale Standard Deviation 3.91
Change From Baseline in the MD-CRS Part II Total Score (Movement Disorder Severity, Centrally Read) Change at Week 54	0.5 units on a scale Standard Deviation 4.34

SECONDARY outcome

Timeframe: Baseline, Week 53, Week 54

Population: 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.

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.

Outcome measures

Measure	TEV-50717 n=26 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) Change at Week 54	-1.4 units on a scale Standard Deviation 3.72
Change From Baseline in the MD-CRS Part I Total Score (General Assessment, Physician Rated) Change at Week 53	-2.6 units on a scale Standard Deviation 3.70

SECONDARY outcome

Timeframe: Baseline, Week 53, Week 54

Population: 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.

The MD-CRS part II evaluates the severity of the movement disorder on a scale of 0 to 4 in 7 body regions, all areas in which dyskinesia can be seen in participants with CP. All items were scored by the investigational center physician. In rating the movement disorder of the 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. The 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.

Outcome measures

Measure	TEV-50717 n=26 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Change From Baseline in the MD-CRS Part II Total Score (General Assessment, Physician Rated) Change at Week 53	-3.12 units on a scale Standard Deviation 4.255
Change From Baseline in the MD-CRS Part II Total Score (General Assessment, Physician Rated) Change at Week 54	-1.88 units on a scale Standard Deviation 3.927

SECONDARY outcome

Timeframe: Baseline, Week 53, Week 54

Population: 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.

The MD-CRS Global Index is a global measure of the MD-CRS that consolidates the information from parts I and II using the method of weighted means of the 2 normalized indexes obtained from each part. The standardized/normalized score for each item of MD-CRS parts I and II with value X is calculated using the formula: Xst = X - Xmin divided by Xmax - Xmin, where Xmax is the maximum value for the score, and Xmin is the minimum value for the score, or 4 and 0 respectively. The normalized index for the scale, MD-CRS parts I or II, Index I or II, is calculated as the mean value of Xst. The MD-CRS Global Index is the weighted mean of the normalized indexes for centrally read MD-CRS parts I and II using the formula: Global index = n1 * index 1 + n2 * index 2 divided by n1 + n2, where n1 and n2 are the numbers of items in MD-CRS parts I and II respectively. The minimum score is 0 (better) and the maximum score is 1 (worse). The higher score indicates more severe movement disorder.

Outcome measures

Measure	TEV-50717 n=26 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Physician Rated) Change at Week 53	-0.1 units on a scale Standard Deviation 0.07
Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Physician Rated) Change at Week 54	-0.0 units on a scale Standard Deviation 0.07

SECONDARY outcome

Timeframe: Baseline, Week 53, Week 54

Population: 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.

The MD-CRS Global Index is a global measure of the MD-CRS that consolidates the information from parts I and II using the method of weighted means of the 2 normalized indexes obtained from each part. The standardized/normalized score for each item of MD-CRS parts I and II with value X is calculated using the formula: Xst = X - Xmin divided by Xmax - Xmin, where Xmax is the maximum value for the score, and Xmin is the minimum value for the score, or 4 and 0 respectively. The normalized index for the scale, MD-CRS parts I or II, Index I or II, is calculated as the mean value of Xst. The MD-CRS Global Index is the weighted mean of the normalized indexes for centrally read MD-CRS parts I and II using the formula: Global index = n1 * index 1 + n2 * index 2 divided by n1 + n2, where n1 and n2 are the numbers of items in MD-CRS parts I and II respectively. The minimum score is 0 (better) and the maximum score is 1 (worse). The higher score indicates more severe movement disorder.

Outcome measures

Measure	TEV-50717 n=30 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Centrally Read) Change at Week 53	-0.0 units on a scale Standard Deviation 0.08
Change From Baseline in MD-CRS Global Index Score (Calculated From MD-CRS Parts I and II Total Scores, Centrally Read) Change at Week 54	-0.0 units on a scale Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: 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.

The CaGI-I is single item questionnaire to assess the caregiver's impression of improvement in dyskinesia symptoms after initiating therapy. The scale is a caregiver-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 caregiver selected the 1 response from the response options that gave the most accurate description of change in dyskinesia symptoms of the participant they cared for from the beginning of the study: 1=very much improved (since the initiation of treatment); 2=much improved; 3=minimally improved; 4=no change from baseline (symptoms remain essentially unchanged); 5=minimally worse; 6=much worse; 7=very much worse (since the initiation of treatment). The change from baseline CaGI-I score can range from -6 to 6.

Outcome measures

Measure

TEV-50717 n=23 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Caregiver Global Impression of Improvement (CaGI-I) Scale Score (Global, Caregiver Rated) at Week 54

-0.6 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: 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.

CGI-I is a clinician-reported outcome with a 7-point Likert scale to compare participant's condition to the baseline condition: 1=very much improved since initiation of treatment (nearly all better; good level of functioning; minimal symptoms; represents a very substantial change); 2=much improved (notably better with significant reduction of symptoms; increase in level of functioning but some symptoms remain); 3=minimally improved (slightly better with little or no clinically meaningful reduction of symptoms; represents very little change in basic clinical status, level of care, or functional capacity); 4=no change from baseline (symptoms remain unchanged); 5=minimally worse (slightly worse but may not be clinically meaningful); 6=much worse (clinically significant increase in symptoms and diminished functioning); 7=very much worse since initiation of treatment (severe exacerbation of symptoms and loss of functioning). The change from baseline CGI-I score can range from -6 to 6.

Outcome measures

Measure

TEV-50717 n=24 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Clinical Global Impression of Improvement (CGI-I) Scale Score (Global, Physician Rated) at Week 54

-0.2 units on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline, Week 54

Population: 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.

The CGI-S uses a 7-point Likert scale to assess dyskinesia severity as follows (with anchor points for choosing the most appropriate severity level caused by DCP): 1=normal (not at all ill, symptoms of disorder not present past 7 days); 2=borderline (subtle or suspected pathology); 3=mild (clearly established symptoms with minimal, if any, distress or difficulty in social and/or occupational function); 4=moderate (overt symptoms causing noticeable, but modest, functional impairment or distress; symptom level may warrant medication); 5=marked (intrusive symptoms that distinctly impair social/occupational function or cause intrusive levels of distress); 6=severe (disruptive symptoms, behavior, and function are frequently influenced by symptoms, may require assistance from others); 7=extreme (symptoms drastically interfere in many life functions; may be hospitalized). Higher scores indicating more severity.

Outcome measures

Measure

TEV-50717 n=24 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Scale Score (Global, Physician Rated) at Week 54

-0.3 units on a scale Standard Deviation 0.64

SECONDARY outcome

Timeframe: Baseline, Week 53

Population: 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.

The PEDI-CAT measures function in 4 domains: (1) Daily Activities; (2) Mobility; (3) Social/Cognitive, and (4) Responsibility. The content-balanced version presents a balance of items from each of the Daily Activities domain's content areas (Getting Dressed, Keeping Clean, Home Tasks, and Eating and Mealtime). A total of approximately 30 items were administered. PEDI-CAT software utilizes Item Response Theory statistical models to estimate a child's abilities from a minimal number of the most relevant items or from a set number of items within each domain. The CAT program then displays the results: normative standard scores, scaled scores, and SE. Scaled score is reported in this endpoint. Scaled scores are based on an estimate of the placement of an individual child along the hierarchical scale within each domain. PEDI-CAT scaled scores are currently on a 20 (lesser improvement) to 80 (more improvement) scale metric. Higher scores indicate greater improvement in functional skills.

Outcome measures

Measure

TEV-50717 n=18 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Pediatric Evaluation Disability Inventory-Computer Adapted Test (PEDI-CAT) Score (Activities of Daily Living [ADL], Caregiver Completed, Content-Balanced Version) at Week 53

0.9 units on a scale Standard Deviation 2.39

SECONDARY outcome

Timeframe: Baseline, Week 53

Population: 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.

The UHDRS-TMC is part of the Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) assessment and assesses the severity of chorea in the 7 body parts: face, mouth, trunk, and the 4 extremities (right and left upper extremities, right and left lower extremities). Each part was rated from 0 (absent) to 4 (prolonged). The central rating was done for all participants, based on the videos collected for the central rating of MD-CRS. The TMC score was obtained by adding up each of the separate scores and ranged from 0 (absent) to 28 (marked/prolonged), with higher scores indicating the worse symptoms.

Outcome measures

Measure

TEV-50717 n=25 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Centrally Read) at Week 53

0.0 units on a scale Standard Deviation 3.20

SECONDARY outcome

Timeframe: Baseline, Week 53

Population: 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.

The UHDRS-TMD is part of the UHDRS-TMS assessment and assesses the severity of dystonia in the 5 body parts: trunk and the 4 extremities (right and left upper extremities, right and left lower extremities). Each part was rated from 0 (absent) to 4 (prolonged). The central rating was done for all participants, based on the videos collected for the central rating of MD-CRS. The TMD score was obtained by adding up each of the separate scores and ranged from 0 (absent) to 20 (marked/prolonged), with higher scores indicating the worse symptoms.

Outcome measures

Measure

TEV-50717 n=25 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD) Score (Centrally Read) at Week 53

-1.0 units on a scale Standard Deviation 3.38

SECONDARY outcome

Timeframe: Baseline, Week 53

Population: 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.

The UHDRS comprises a broad assessment of features associated with Huntington's disease (HD). It is a research tool that has been developed to provide a uniform assessment of the clinical features and course of HD. The Total Motor Score assessment of the UHDRS (UHDRS-TMS) comprises 15 items and assesses eye movements, speech, alternating hand movements, dystonia, chorea, and gait. The UHDRS-TMS was calculated as the sum of the 31 motor assessments; each of which ranged between 0 (absent) to 4 (worst). All items were scored by the investigational center physician. TMS score is a sum of individual scores ranging from 0 (normal motor function) to 124 (severely impaired motor function), with lower scores indicating better motor function.

Outcome measures

Measure

TEV-50717 n=26 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) Score (Physician Rated) at Week 53

-7.8 units on a scale Standard Deviation 7.78

SECONDARY outcome

Timeframe: Baseline, Week 53

Population: 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.

The UHDRS-TMC is part of the UHDRS-TMS assessment and assesses the severity of chorea in the 7 body parts: face, mouth, trunk, and the 4 extremities (right and left upper extremities, right and left lower extremities). Each part was rated from 0 (absent) to 4 (prolonged). All items were scored by the investigational center physician. The TMC score was obtained by adding up each of the separate scores and ranged from 0 (absent) to 28 (marked/prolonged), with higher scores indicating the worse symptoms.

Outcome measures

Measure

TEV-50717 n=26 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Chorea (UHDRS-TMC) Score (Physician Rated) at Week 53

-3.9 units on a scale Standard Deviation 4.50

SECONDARY outcome

Timeframe: Baseline, Week 53

Population: 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.

The UHDRS-TMD is part of the UHDRS-TMS assessment and assesses the severity of dystonia in the 5 body parts: trunk and the 4 extremities (right and left upper extremities, right and left lower extremities). Each part was rated from 0 (absent) to 4 (prolonged). All items were scored by the investigational center physician. The TMD score was obtained by adding up each of the separate scores and ranged from 0 (absent) to 20 (marked/prolonged), with higher scores indicating the worse symptoms.

Outcome measures

Measure

TEV-50717 n=26 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Unified Huntington's Disease Rating Scale-Total Maximal Dystonia (UHDRS-TMD) Score (Physician Rated) at Week 53

-0.9 units on a scale Standard Deviation 1.65

SECONDARY outcome

Timeframe: Baseline, Week 53

Population: 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.

The COPM, a semi-structured interview, was used to assess a participant's perception of performance in the areas of self-care, productivity and leisure. The COPM involves a 5-step process within a semi-structured interview conducted by a therapist. The participants were asked to rate 5 most important activities on a 10-point scale for performance and satisfaction, ranging from 1 (not at all able/satisfied) to 10 (able to perform extremely well/ extremely satisfied). Total score is the average of the total performance and satisfaction subscales. Each subscale score is calculated by adding the scores of all activities and then dividing by the number of the activities. The total change from baseline scores can range from -9 to 9. Higher scores indicated very good performance and high satisfaction.

Outcome measures

Measure

TEV-50717 n=27 Participants TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.

Change From Baseline in Canadian Occupational Performance Measure (COPM) (Physician Rated) Score at Week 53

1.4 units on a scale Standard Deviation 1.36

Adverse Events

TEV-50717

Serious events: 1 serious events

Other events: 33 other events

Deaths: 1 deaths

Serious adverse events

Measure	TEV-50717 n=44 participants at risk TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Cardiac disorders Cardiopulmonary failure	2.3% 1/44 • Number of events 1 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Infections and infestations COVID-19	2.3% 1/44 • Number of events 1 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Nervous system disorders Seizure	2.3% 1/44 • Number of events 1 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.

Other adverse events

Measure	TEV-50717 n=44 participants at risk TEV-50717 was administered as oral tablets once daily for up to 53 weeks (7 weeks dose titration and 46 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 CGI-I) and was well tolerated. After titration, participants continued to receive their maintenance dose over the next 46 weeks.
Gastrointestinal disorders Abdominal pain	6.8% 3/44 • Number of events 6 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Gastrointestinal disorders Constipation	6.8% 3/44 • Number of events 3 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Gastrointestinal disorders Diarrhoea	9.1% 4/44 • Number of events 4 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Gastrointestinal disorders Vomiting	9.1% 4/44 • Number of events 4 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
General disorders Fatigue	6.8% 3/44 • Number of events 3 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
General disorders Pyrexia	6.8% 3/44 • Number of events 5 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Infections and infestations COVID-19	9.1% 4/44 • Number of events 4 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Infections and infestations Upper respiratory tract infection	6.8% 3/44 • Number of events 3 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Nervous system disorders Akathisia	6.8% 3/44 • Number of events 4 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Nervous system disorders Dystonia	6.8% 3/44 • Number of events 7 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Nervous system disorders Headache	6.8% 3/44 • Number of events 3 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Nervous system disorders Somnolence	47.7% 21/44 • Number of events 32 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Psychiatric disorders Insomnia	6.8% 3/44 • Number of events 5 • Baseline up to Week 55 The ITT analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 888-483-8279

Email: USMedInfo@tevapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
• Publication restrictions are in place

Restriction type: OTHER