Trial Outcomes & Findings for A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder (NCT NCT02436239)
NCT ID: NCT02436239
Last Updated: 2019-09-11
Results Overview
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
330 participants
Primary outcome timeframe
Visit 1 (Week -1) to up to Visit 16 (Week 26)
Results posted on
2019-09-11
Participant Flow
Patients who completed lead-in study VLZ-MD-22 (NCT02372799) had already completed a down-taper period at the end of study VLZ-MD-22 and were not required to undergo a washout period in VLZ-MD-23. For de novo patients, the screening/washout period was generally 1 week prior to Baseline.
Participant milestones
| Measure |
Placebo/Vilazodone
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Open-Lable Treatment Period
STARTED
|
122
|
131
|
65
|
12
|
|
Open-Lable Treatment Period
COMPLETED
|
89
|
97
|
38
|
7
|
|
Open-Lable Treatment Period
NOT COMPLETED
|
33
|
34
|
27
|
5
|
|
Down-Taper Period
STARTED
|
90
|
103
|
44
|
6
|
|
Down-Taper Period
COMPLETED
|
86
|
99
|
43
|
4
|
|
Down-Taper Period
NOT COMPLETED
|
4
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo/Vilazodone
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Open-Lable Treatment Period
Adverse Event
|
12
|
3
|
4
|
2
|
|
Open-Lable Treatment Period
Lack of Efficacy
|
1
|
6
|
6
|
1
|
|
Open-Lable Treatment Period
Withdrawal by Subject
|
10
|
15
|
9
|
0
|
|
Open-Lable Treatment Period
Lost to Follow-up
|
4
|
2
|
4
|
1
|
|
Open-Lable Treatment Period
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Open-Lable Treatment Period
Noncompliance with Study Drug
|
5
|
6
|
3
|
1
|
|
Open-Lable Treatment Period
Other Reason
|
1
|
1
|
0
|
0
|
|
Down-Taper Period
Withdrawal by Subject
|
4
|
4
|
1
|
2
|
Baseline Characteristics
The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
Baseline characteristics by cohort
| Measure |
Placebo/Vilazodone
n=122 Participants
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
n=131 Participants
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
n=65 Participants
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
n=12 Participants
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.2 Years
STANDARD_DEVIATION 2.9 • n=122 Participants
|
13.3 Years
STANDARD_DEVIATION 2.8 • n=131 Participants
|
13.2 Years
STANDARD_DEVIATION 2.8 • n=65 Participants
|
13.0 Years
STANDARD_DEVIATION 2.9 • n=12 Participants
|
13.3 Years
STANDARD_DEVIATION 2.9 • n=330 Participants
|
|
Age, Customized
Age 7-11 Years
|
37 Participants
n=122 Participants
|
35 Participants
n=131 Participants
|
19 Participants
n=65 Participants
|
4 Participants
n=12 Participants
|
95 Participants
n=330 Participants
|
|
Age, Customized
Age 12-17 Years
|
83 Participants
n=122 Participants
|
93 Participants
n=131 Participants
|
46 Participants
n=65 Participants
|
8 Participants
n=12 Participants
|
230 Participants
n=330 Participants
|
|
Age, Customized
Age 18 Years
|
2 Participants
n=122 Participants
|
3 Participants
n=131 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=12 Participants
|
5 Participants
n=330 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=122 Participants
|
89 Participants
n=131 Participants
|
33 Participants
n=65 Participants
|
7 Participants
n=12 Participants
|
197 Participants
n=330 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=122 Participants
|
42 Participants
n=131 Participants
|
32 Participants
n=65 Participants
|
5 Participants
n=12 Participants
|
133 Participants
n=330 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=122 Participants
|
16 Participants
n=131 Participants
|
8 Participants
n=65 Participants
|
2 Participants
n=12 Participants
|
42 Participants
n=330 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=122 Participants
|
115 Participants
n=131 Participants
|
57 Participants
n=65 Participants
|
10 Participants
n=12 Participants
|
288 Participants
n=330 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=122 Participants
|
0 Participants
n=131 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=330 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=122 Participants
|
0 Participants
n=131 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=122 Participants
|
1 Participants
n=131 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=12 Participants
|
7 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=122 Participants
|
2 Participants
n=131 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=122 Participants
|
40 Participants
n=131 Participants
|
20 Participants
n=65 Participants
|
1 Participants
n=12 Participants
|
93 Participants
n=330 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=122 Participants
|
84 Participants
n=131 Participants
|
42 Participants
n=65 Participants
|
11 Participants
n=12 Participants
|
219 Participants
n=330 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=122 Participants
|
4 Participants
n=131 Participants
|
2 Participants
n=65 Participants
|
0 Participants
n=12 Participants
|
9 Participants
n=330 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=122 Participants
|
0 Participants
n=131 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=330 Participants
|
|
Weight
|
57.98 kg
STANDARD_DEVIATION 23.54 • n=122 Participants
|
62.67 kg
STANDARD_DEVIATION 25.26 • n=131 Participants
|
59.36 kg
STANDARD_DEVIATION 18.93 • n=65 Participants
|
60.34 kg
STANDARD_DEVIATION 17.87 • n=12 Participants
|
60.17 kg
STANDARD_DEVIATION 23.26 • n=330 Participants
|
|
Body Mass Index (BMI)
|
22.73 kg/m^2
STANDARD_DEVIATION 6.59 • n=122 Participants
|
24.75 kg/m^2
STANDARD_DEVIATION 7.96 • n=131 Participants
|
23.30 kg/m^2
STANDARD_DEVIATION 5.37 • n=65 Participants
|
23.90 kg/m^2
STANDARD_DEVIATION 6.20 • n=12 Participants
|
23.69 kg/m^2
STANDARD_DEVIATION 6.98 • n=330 Participants
|
|
CDRS-R total score
|
55.7 units on a scale
STANDARD_DEVIATION 9.6 • n=121 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
59.3 units on a scale
STANDARD_DEVIATION 9.5 • n=130 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
57.8 units on a scale
STANDARD_DEVIATION 8.7 • n=63 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
59.7 units on a scale
STANDARD_DEVIATION 9.1 • n=11 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
58.4 units on a scale
STANDARD_DEVIATION 9.3 • n=325 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
|
CGI-S score
|
4.6 units on a scale
STANDARD_DEVIATION 0.6 • n=121 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
4.7 units on a scale
STANDARD_DEVIATION 0.7 • n=130 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
4.6 units on a scale
STANDARD_DEVIATION 0.6 • n=63 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
4.2 units on a scale
STANDARD_DEVIATION 0.4 • n=11 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
4.6 units on a scale
STANDARD_DEVIATION 0.6 • n=325 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
PRIMARY outcome
Timeframe: Visit 1 (Week -1) to up to Visit 16 (Week 26)Population: The Safety Population consisted of the 330 participants who took at least 1 dose of open-label investigational product.
The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period
Outcome measures
| Measure |
Placebo/Vilazodone
n=122 Participants
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
n=131 Participants
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
n=65 Participants
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
n=12 Participants
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)
|
90 Participants
|
89 Participants
|
48 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 26Population: The Change From Baseline in the CDRS-R Total Score was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
Outcome measures
| Measure |
Placebo/Vilazodone
n=121 Participants
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
n=130 Participants
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
n=63 Participants
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
n=11 Participants
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Change From Baseline in the CDRS-R Total Score
|
-29.2 units on a scale
Standard Deviation 11.9
|
-30.1 units on a scale
Standard Deviation 12.2
|
-29.4 units on a scale
Standard Deviation 12.2
|
-24.5 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 26Population: The CGI-S was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.
Outcome measures
| Measure |
Placebo/Vilazodone
n=121 Participants
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
n=130 Participants
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
n=63 Participants
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
n=11 Participants
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Change From Baseline in the CGI-S Score
|
-2.5 units on a scale
Standard Deviation 1.3
|
-2.6 units on a scale
Standard Deviation 1.4
|
-2.5 units on a scale
Standard Deviation 1.4
|
-1.7 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 26Population: The CGI-I was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.
Outcome measures
| Measure |
Placebo/Vilazodone
n=121 Participants
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
n=130 Participants
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
n=63 Participants
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
n=11 Participants
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)
|
2.1 units on a scale
Standard Deviation 1.2
|
2.0 units on a scale
Standard Deviation 1.3
|
2.0 units on a scale
Standard Deviation 1.2
|
2.2 units on a scale
Standard Deviation 1.2
|
Adverse Events
Placebo/Vilazodone
Serious events: 6 serious events
Other events: 79 other events
Deaths: 0 deaths
Vilazodone/Vilazodone
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Fluoxetine/Vilazodone
Serious events: 1 serious events
Other events: 41 other events
Deaths: 1 deaths
De Novo/Vilazodone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Vilazodone
n=122 participants at risk
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
n=131 participants at risk
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
n=65 participants at risk
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
n=12 participants at risk
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
2/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.82%
1/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Psychiatric disorders
Aggression
|
0.82%
1/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Infections and infestations
Appendicitis
|
0.82%
1/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
1.5%
1/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Psychiatric disorders
Suicide attempt
|
0.82%
1/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
Other adverse events
| Measure |
Placebo/Vilazodone
n=122 participants at risk
Participants who received placebo during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Vilazodone/Vilazodone
n=131 participants at risk
Participants who received vilazodone during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
Fluoxetine/Vilazodone
n=65 participants at risk
Participants who received Fluoxetine during the lead in study, VLZ-MD-22, were given vilazodone tablets once daily, oral administration.
|
De Novo/Vilazodone
n=12 participants at risk
Newly enrolled participants received vilazodone tablets once daily, oral administration.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.76%
1/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
16.7%
2/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Gastrointestinal disorders
Nausea
|
22.1%
27/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
12.2%
16/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
12.3%
8/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
16.7%
2/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Gastrointestinal disorders
Vomiting
|
12.3%
15/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
6.1%
8/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
4.6%
3/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
12/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
4.6%
6/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
6.2%
4/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
5/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.4%
11/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
3.1%
2/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Infections and infestations
Gastroenteritis
|
4.9%
6/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
2.3%
3/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
4.6%
3/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.3%
1/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Infections and infestations
Sinusitis
|
0.82%
1/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
3.8%
5/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
3.1%
2/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.3%
1/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Investigations
Weight increased
|
5.7%
7/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
11.5%
15/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
6.2%
4/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.3%
1/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Nervous system disorders
Headache
|
17.2%
21/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
21.4%
28/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
12.3%
8/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
16.7%
2/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Nervous system disorders
Dizziness
|
2.5%
3/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
6.9%
9/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
6.2%
4/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Nervous system disorders
Migraine
|
2.5%
3/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
2.3%
3/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
1.5%
1/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.3%
1/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
16.7%
2/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Psychiatric disorders
Insomnia
|
10.7%
13/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.4%
11/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
3.1%
2/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysmenorrhea
|
2.5%
3/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
3.1%
4/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
4.6%
3/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Psychiatric disorders
Irritability
|
3.3%
4/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
2.3%
3/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.3%
1/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
1.5%
2/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.3%
1/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/122 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/131 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
0.00%
0/65 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
8.3%
1/12 • Adverse event data was collected for up to 28 weeks, which consists of the screening visit (1 week), the 26 week open label treatment period and during the 1 week down taper period.
|
Additional Information
Armin Szegedi, MD, PhD, Vice President CNS Clinical Development
Allergan
Phone: 714-246-4500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study are the property of the sponsor. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and the sponsor and will follow sponsor's standard operating procedures on publications.
- Publication restrictions are in place
Restriction type: OTHER