Trial Outcomes & Findings for Vortioxetine to Prevent Return of Symptoms in Children With Depression (NCT NCT05014919)
NCT ID: NCT05014919
Last Updated: 2023-01-05
Results Overview
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
TERMINATED
PHASE3
35 participants
From randomization to Week 26 in the double-blind treatment period
2023-01-05
Participant Flow
The study population included de novo participants as well as rollover participants from other paediatric vortioxetine studies (Studies 12709A \[NCT02709655\] and 12712A \[NCT02871297\]) who, in the investigator's opinion, would benefit from continued treatment with vortioxetine.
Rollover participants from Study 12709A enrolled to the open-label period and rollover participants (remitters) from Study 12712A randomized to the double-blind period. Overall, 35 participants were treated in this study: 33 participants in the open-label period (24 de novo participants and 9 rollover participants from Study 12709A) and 4 participants in the double-blind period (2 of whom rolled-over from Study 12712A).
Participant milestones
| Measure |
Open-Label Treatment: Vortioxetine
Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.
|
Double-Blind Relapse Prevention: Vortioxetine
Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.
|
Double-Blind Relapse Prevention: Placebo
Participants received placebo for 26 weeks in the double-blind relapse prevention period.
|
|---|---|---|---|
|
Open-Label (12 Weeks)
STARTED
|
33
|
0
|
0
|
|
Open-Label (12 Weeks)
Received at Least 1 Dose of Study Drug
|
33
|
0
|
0
|
|
Open-Label (12 Weeks)
COMPLETED
|
5
|
0
|
0
|
|
Open-Label (12 Weeks)
NOT COMPLETED
|
28
|
0
|
0
|
|
Double-Blind (26 Weeks)
STARTED
|
0
|
2
|
2
|
|
Double-Blind (26 Weeks)
Received at Least 1 Dose of Study Drug
|
0
|
2
|
2
|
|
Double-Blind (26 Weeks)
COMPLETED
|
0
|
1
|
0
|
|
Double-Blind (26 Weeks)
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Open-Label Treatment: Vortioxetine
Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.
|
Double-Blind Relapse Prevention: Vortioxetine
Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.
|
Double-Blind Relapse Prevention: Placebo
Participants received placebo for 26 weeks in the double-blind relapse prevention period.
|
|---|---|---|---|
|
Open-Label (12 Weeks)
Adverse Event
|
1
|
0
|
0
|
|
Open-Label (12 Weeks)
Lack of Efficacy
|
1
|
0
|
0
|
|
Open-Label (12 Weeks)
Withdrawal by Subject
|
2
|
0
|
0
|
|
Open-Label (12 Weeks)
Based on Sponsor Information of Results From Vortioxetine Study
|
15
|
0
|
0
|
|
Open-Label (12 Weeks)
Sponsor Decision
|
4
|
0
|
0
|
|
Open-Label (12 Weeks)
Study Terminated by Sponsor
|
5
|
0
|
0
|
|
Double-Blind (26 Weeks)
Study Terminated by Sponsor
|
0
|
0
|
1
|
|
Double-Blind (26 Weeks)
Based on Sponsor Information of Results From Vortioxetine Study
|
0
|
1
|
1
|
Baseline Characteristics
Data are being reported separately for the open-label and double-blind arms.
Baseline characteristics by cohort
| Measure |
Open-Label Treatment: Vortioxetine
n=33 Participants
Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.
|
Double-Blind Relapse Prevention: Vortioxetine
n=2 Participants
Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.
|
Double-Blind Relapse Prevention: Placebo
n=2 Participants
Participants received placebo for 26 weeks in the double-blind relapse prevention period.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Open-Label Treatment · Children (2-11 years)
|
27 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
27 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Age, Customized
Open-Label Treatment · Adolescents (12-17 years)
|
6 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
6 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Age, Customized
Double-Blind Relapse Prevention · Children (2-11 years)
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
4 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Age, Customized
Double-Blind Relapse Prevention · Adolescents (12-17 years)
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Sex: Female, Male
Open-Label Treatment · Female
|
18 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
18 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Sex: Female, Male
Open-Label Treatment · Male
|
15 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
15 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Sex: Female, Male
Double-Blind Relapse Prevention · Female
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Sex: Female, Male
Double-Blind Relapse Prevention · Male
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Ethnicity (NIH/OMB)
Open-Label Treatment · Hispanic or Latino
|
18 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
18 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Ethnicity (NIH/OMB)
Open-Label Treatment · Not Hispanic or Latino
|
15 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
15 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Ethnicity (NIH/OMB)
Open-Label Treatment · Unknown or Not Reported
|
0 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Ethnicity (NIH/OMB)
Double-Blind Relapse Prevention · Hispanic or Latino
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
3 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Ethnicity (NIH/OMB)
Double-Blind Relapse Prevention · Not Hispanic or Latino
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Ethnicity (NIH/OMB)
Double-Blind Relapse Prevention · Unknown or Not Reported
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Treatment · White
|
13 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
13 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Treatment · Black or African American
|
3 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
3 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Treatment · Asian
|
1 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
1 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Open-Label Treatment · Other
|
16 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
16 Participants
n=33 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Relapse Prevention · White
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Relapse Prevention · Black or African American
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Relapse Prevention · Asian
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
|
Race/Ethnicity, Customized
Double-Blind Relapse Prevention · Other
|
0 Participants
Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
0 Participants
n=2 Participants • Data are being reported separately for the open-label and double-blind arms.
|
2 Participants
n=4 Participants • Data are being reported separately for the open-label and double-blind arms.
|
PRIMARY outcome
Timeframe: From randomization to Week 26 in the double-blind treatment periodPopulation: Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to Week 26 in the double-blind treatment periodPopulation: Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.
Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.
The CGI-S provides the clinician's impression of the participant's current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill participants).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 26Population: Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.
The CGI-I provides the clinician's impression of the participant's improvement (or worsening). The clinician assesses the participant's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this outcome measure.
The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to Week 26 in the double-blind treatment periodPopulation: Due to early termination of the study, the pharmacokinetic analyses were not performed and the data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Open-Label Treatment: Vortioxetine
Double-Blind Relapse Prevention: Placebo
Double-Blind Relapse Prevention: Vortioxetine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-Label Treatment: Vortioxetine
n=33 participants at risk
Participants initiated treatment with vortioxetine tablets 5 mg/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting AEs, vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.
|
Double-Blind Relapse Prevention: Placebo
n=2 participants at risk
Participants received placebo for 26 weeks in the double-blind relapse prevention period.
|
Double-Blind Relapse Prevention: Vortioxetine
n=2 participants at risk
Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Food poisoning
|
3.0%
1/33 • Number of events 1 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
6/33 • Number of events 7 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • Number of events 2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Infections and infestations
Coronavirus infection
|
3.0%
1/33 • Number of events 1 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Infections and infestations
Influenza
|
3.0%
1/33 • Number of events 1 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/33 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
50.0%
1/2 • Number of events 1 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Investigations
Electrocardiogram QT prolonged
|
3.0%
1/33 • Number of events 1 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • Number of events 1 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Number of events 1 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
0.00%
0/2 • Baseline (Week 0) up to Week 42
All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place