Trial Outcomes & Findings for Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD) (NCT NCT03614156)
NCT ID: NCT03614156
Last Updated: 2020-10-09
Results Overview
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
363 participants
Primary outcome timeframe
52 Weeks
Results posted on
2020-10-09
Participant Flow
Patients from RAP-MD-33 completed one of the rapastinel lead-in studies - RAP-MD-30, RAP-MD-31, or RAP-MD-32.
363 patients enrolled in the Open Label Treatment Period (OLTP). Of these, 209 completed OLTP and 137 entered Double Blind Treatment Period (DBTP) and were randomized. Patients who completed or discontinued from the study can enter a 2-wk safety follow-up period (SFUP). 165 patients from OLTP and 91 patients from DBTP entered the SFUP.
Participant milestones
| Measure |
Open-Label Treatment Period (OLTP) Weekly Rapastinel
Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP.
|
DBTP Placebo Weekly
Placebo (prefilled syringe, weekly IV administration)
|
DBTP Rapastinel Clinically Driven Schedule
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
|
DBTP Rapastinel Weekly
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
|
|---|---|---|---|---|
|
Open-Label Treatment Period
STARTED
|
363
|
0
|
0
|
0
|
|
Open-Label Treatment Period
COMPLETED
|
209
|
0
|
0
|
0
|
|
Open-Label Treatment Period
NOT COMPLETED
|
154
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DBTP)
STARTED
|
0
|
40
|
42
|
55
|
|
Double-Blind Treatment Period (DBTP)
COMPLETED
|
0
|
10
|
11
|
10
|
|
Double-Blind Treatment Period (DBTP)
NOT COMPLETED
|
0
|
30
|
31
|
45
|
|
Safety Follow-Up Period
STARTED
|
165
|
26
|
30
|
35
|
|
Safety Follow-Up Period
COMPLETED
|
162
|
26
|
29
|
34
|
|
Safety Follow-Up Period
NOT COMPLETED
|
3
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Open-Label Treatment Period (OLTP) Weekly Rapastinel
Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP.
|
DBTP Placebo Weekly
Placebo (prefilled syringe, weekly IV administration)
|
DBTP Rapastinel Clinically Driven Schedule
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
|
DBTP Rapastinel Weekly
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
|
|---|---|---|---|---|
|
Open-Label Treatment Period
Protocol-specified withdrawal met
|
6
|
0
|
0
|
0
|
|
Open-Label Treatment Period
Adverse Event
|
7
|
0
|
0
|
0
|
|
Open-Label Treatment Period
Lack of Efficacy
|
18
|
0
|
0
|
0
|
|
Open-Label Treatment Period
Withdrawal by Subject
|
36
|
0
|
0
|
0
|
|
Open-Label Treatment Period
Lost to Follow-up
|
10
|
0
|
0
|
0
|
|
Open-Label Treatment Period
Protocol Violation
|
2
|
0
|
0
|
0
|
|
Open-Label Treatment Period
Non-compliance with study drug
|
1
|
0
|
0
|
0
|
|
Open-Label Treatment Period
Study terminated by sponsor
|
74
|
0
|
0
|
0
|
|
Double-Blind Treatment Period (DBTP)
Adverse Event
|
0
|
2
|
0
|
1
|
|
Double-Blind Treatment Period (DBTP)
Withdrawal by Subject
|
0
|
4
|
1
|
1
|
|
Double-Blind Treatment Period (DBTP)
Lost to Follow-up
|
0
|
0
|
3
|
4
|
|
Double-Blind Treatment Period (DBTP)
Protocol Violation
|
0
|
1
|
1
|
1
|
|
Double-Blind Treatment Period (DBTP)
Study terminated by sponsor
|
0
|
22
|
26
|
38
|
|
Double-Blind Treatment Period (DBTP)
Miscellaneous Reasons
|
0
|
1
|
0
|
0
|
|
Safety Follow-Up Period
Miscellaneous Reasons
|
2
|
0
|
0
|
0
|
|
Safety Follow-Up Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Safety Follow-Up Period
Lost to Follow-up
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
DBTP Placebo Weekly
n=40 Participants
Placebo (prefilled syringe, weekly IV administration)
|
DBTP Rapastinel Clinically Driven Schedule
n=42 Participants
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
|
DBTP Rapastinel Weekly
n=55 Participants
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47 Years
STANDARD_DEVIATION 13.95 • n=5 Participants
|
43.6 Years
STANDARD_DEVIATION 12.57 • n=7 Participants
|
43.9 Years
STANDARD_DEVIATION 11.66 • n=5 Participants
|
44.7 Years
STANDARD_DEVIATION 12.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight
|
84.84 kg
STANDARD_DEVIATION 17.86 • n=5 Participants
|
85.88 kg
STANDARD_DEVIATION 19.21 • n=7 Participants
|
88.53 kg
STANDARD_DEVIATION 19.24 • n=5 Participants
|
86.64 kg
STANDARD_DEVIATION 18.77 • n=4 Participants
|
|
Height
|
168.31 cm
STANDARD_DEVIATION 8.996 • n=5 Participants
|
166.92 cm
STANDARD_DEVIATION 9.858 • n=7 Participants
|
168.47 cm
STANDARD_DEVIATION 9.196 • n=5 Participants
|
167.95 cm
STANDARD_DEVIATION 9.304 • n=4 Participants
|
|
BMI
|
29.89 kg/m^2
STANDARD_DEVIATION 5.686 • n=5 Participants
|
30.95 kg/m^2
STANDARD_DEVIATION 7.289 • n=7 Participants
|
31.15 kg/m^2
STANDARD_DEVIATION 6.279 • n=5 Participants
|
30.72 kg/m^2
STANDARD_DEVIATION 6.421 • n=4 Participants
|
PRIMARY outcome
Timeframe: 52 WeeksPopulation: The Double-blind Safety Population consisted of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of double-blind IP.
The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.
Outcome measures
| Measure |
DBTP Placebo Weekly
n=40 Participants
Placebo (prefilled syringe, weekly IV administration)
|
DBTP Rapastinel Clinically Driven Schedule
n=42 Participants
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
|
DBTP Rapastinel Weekly
n=55 Participants
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
|
|---|---|---|---|
|
Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP)
|
NA Days
Not enough events to allow the estimation of the percentiles and the standard error for the confidence intervals.
|
203 Days
Interval 177.0 to
Not enough events to allow the estimation of the percentiles and the standard error for the confidence intervals.
|
NA Days
Not enough events to allow the estimation of the percentiles and the standard error for the confidence intervals.
|
Adverse Events
Open-Label Treatment Period
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
DBTP Placebo Weekly
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
DBTP Rapastinel Clinically Driven Schedule
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
DBTP Rapastinel Weekly
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-Label Treatment Period
n=363 participants at risk
Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP.
|
DBTP Placebo Weekly
n=40 participants at risk
Placebo (prefilled syringe, weekly IV administration)
|
DBTP Rapastinel Clinically Driven Schedule
n=42 participants at risk
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
|
DBTP Rapastinel Weekly
n=55 participants at risk
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
|
|---|---|---|---|---|
|
Nervous system disorders
Partial seizures
|
0.28%
1/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.28%
1/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Psychiatric disorders
Suicide attempt
|
0.28%
1/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.28%
1/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
2.5%
1/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
2.4%
1/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
Other adverse events
| Measure |
Open-Label Treatment Period
n=363 participants at risk
Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP.
|
DBTP Placebo Weekly
n=40 participants at risk
Placebo (prefilled syringe, weekly IV administration)
|
DBTP Rapastinel Clinically Driven Schedule
n=42 participants at risk
Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
|
DBTP Rapastinel Weekly
n=55 participants at risk
Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.2%
26/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
9.5%
4/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
9.1%
5/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Nervous system disorders
Headache
|
5.5%
20/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
7.5%
3/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
2.4%
1/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.5%
3/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
5.0%
18/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
2.5%
1/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
9.5%
4/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.5%
3/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
4/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.0%
2/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
2.4%
1/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
3.6%
2/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Immune system disorders
Seasonal allergy
|
0.28%
1/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
10.0%
4/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
1.8%
1/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.55%
2/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
7.5%
3/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
1.8%
1/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Infections and infestations
Bronchitis
|
0.55%
2/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.0%
2/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
1.8%
1/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Psychiatric disorders
Insomnia
|
4.1%
15/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
7.5%
3/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
2.4%
1/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.55%
2/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.0%
2/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
2.4%
1/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.0%
2/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
General disorders
Pyrexia
|
0.55%
2/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.0%
2/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
|
Nervous system disorders
Dizziness
|
0.28%
1/363 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
5.0%
2/40 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/42 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
0.00%
0/55 • The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER