Trial Outcomes & Findings for A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure (NCT NCT06635135)
NCT ID: NCT06635135
Last Updated: 2026-06-08
Results Overview
Relapse is defined as any of the following: MADRS total score \>=22 for 2 consecutive assessments separated by 7 (+/-3) days and/or hospitalization or observation for worsening depression, or any clinically relevant event per clinical judgment suggestive of relapse of depressive illness, such as active suicidal ideation with intent or evidence of suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide attempt, completed suicide, or hospitalization for suicide prevention. Relapse date is defined by the second MADRS assessment. MADRS is a clinician-rated 10-item scale scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), with higher scores indicating more severe symptoms. C-SSRS is clinician-rated and reports severity and frequency of suicide-related ideation and behavior, categorized as no ideation/behavior (0), suicidal ideation (1 -5), or suicidal behavior (6 -10), with higher scores reflecting greater severity.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
47 participants
Primary outcome timeframe
From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140])
Results posted on
2026-06-08
Participant Flow
Adult subjects who had major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+) and an inadequate response to an ongoing antidepressant therapy were treated. Study was conducted in 3 phases: Open label (OL) initial treatment phase (IN), OL treatment stabilization (ST) phase and double blind (DB) treatment maintenance (TM) phase.
Subjects who were stable responders in OL phase were planned to be randomised to receive either aticaprant or placebo. Since no subject was randomised to placebo, results for only the aticaprant arm are presented for the DB (TM) phase.
Participant milestones
| Measure |
OL (IN) Phase: Aticaprant 10 mg
During OL (IN) phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 up to 6 weeks in addition to the ongoing antidepressant therapy selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake Inhibitors (SNRI). Participants who were responders (50 percent \[%\] or more reduction in the Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from the OL baseline \[Day 1, prior to first dose\] to the end of the OL initial treatment phase \[Week 6\]) to adjunctive aticaprant treatment entered the OL (ST) phase. Participants who were non-responders were followed up for safety up to 2 weeks.
|
OL (ST) Phase: Aticaprant 10 mg
Participants who were responders (50% or more reduction in the MADRS total score from the OL baseline \[Day 1, prior to first dose\] to the end of the OL initial treatment phase \[Week 6\]) to adjunctive aticaprant treatment during OL (IN) phase entered the OL (ST) phase and continue to receive aticaprant 10 mg tablet orally once daily for additional 10 weeks (up to Week 16) in addition to the ongoing antidepressant therapy (SSRI/SNRI). At Week 16, participants entered into the double blind (DB) treatment maintenance phase. Participants who did not enter the DB treatment maintenance phase were followed up for safety up to 2 weeks.
|
DB Treatment Maintenance Phase: Aticaprant 10 mg
At Week 16, participants who were stable responders (50% or more reduction in the MADRS total score from the OL baseline in each of the last 2 consecutive assessments of the OL treatment stabilization phase \[Week 14 and Week 16\] with no MADRS total score \>=19 at these assessments) were randomized and the participants who did not meet criteria for stable response were sham randomized to receive aticaprant 10 mg tablet orally once daily from Day 113 until the required number of relapse events were achieved in addition to the ongoing antidepressant therapy. Participants who relapsed were then followed up for safety up to 2 weeks. Participants who had not relapsed and discontinued study intervention were followed up until they relapse or the study was terminated by the sponsor on Day 140.
|
|---|---|---|---|
|
OL Initial Treatment Phase (Week 1-6)
STARTED
|
47
|
0
|
0
|
|
OL Initial Treatment Phase (Week 1-6)
COMPLETED
|
19
|
0
|
0
|
|
OL Initial Treatment Phase (Week 1-6)
NOT COMPLETED
|
28
|
0
|
0
|
|
OL Treatment ST Phase (From Week 7-16)
STARTED
|
0
|
18
|
0
|
|
OL Treatment ST Phase (From Week 7-16)
COMPLETED
|
0
|
2
|
0
|
|
OL Treatment ST Phase (From Week 7-16)
NOT COMPLETED
|
0
|
16
|
0
|
|
DB TM Phase (From Week 16-20)
STARTED
|
0
|
0
|
2
|
|
DB TM Phase (From Week 16-20)
COMPLETED
|
0
|
0
|
0
|
|
DB TM Phase (From Week 16-20)
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
OL (IN) Phase: Aticaprant 10 mg
During OL (IN) phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 up to 6 weeks in addition to the ongoing antidepressant therapy selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake Inhibitors (SNRI). Participants who were responders (50 percent \[%\] or more reduction in the Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from the OL baseline \[Day 1, prior to first dose\] to the end of the OL initial treatment phase \[Week 6\]) to adjunctive aticaprant treatment entered the OL (ST) phase. Participants who were non-responders were followed up for safety up to 2 weeks.
|
OL (ST) Phase: Aticaprant 10 mg
Participants who were responders (50% or more reduction in the MADRS total score from the OL baseline \[Day 1, prior to first dose\] to the end of the OL initial treatment phase \[Week 6\]) to adjunctive aticaprant treatment during OL (IN) phase entered the OL (ST) phase and continue to receive aticaprant 10 mg tablet orally once daily for additional 10 weeks (up to Week 16) in addition to the ongoing antidepressant therapy (SSRI/SNRI). At Week 16, participants entered into the double blind (DB) treatment maintenance phase. Participants who did not enter the DB treatment maintenance phase were followed up for safety up to 2 weeks.
|
DB Treatment Maintenance Phase: Aticaprant 10 mg
At Week 16, participants who were stable responders (50% or more reduction in the MADRS total score from the OL baseline in each of the last 2 consecutive assessments of the OL treatment stabilization phase \[Week 14 and Week 16\] with no MADRS total score \>=19 at these assessments) were randomized and the participants who did not meet criteria for stable response were sham randomized to receive aticaprant 10 mg tablet orally once daily from Day 113 until the required number of relapse events were achieved in addition to the ongoing antidepressant therapy. Participants who relapsed were then followed up for safety up to 2 weeks. Participants who had not relapsed and discontinued study intervention were followed up until they relapse or the study was terminated by the sponsor on Day 140.
|
|---|---|---|---|
|
OL Initial Treatment Phase (Week 1-6)
Adverse Event
|
1
|
0
|
0
|
|
OL Initial Treatment Phase (Week 1-6)
Lack of Efficacy
|
1
|
0
|
0
|
|
OL Initial Treatment Phase (Week 1-6)
Study Terminated by Sponsor
|
25
|
0
|
0
|
|
OL Initial Treatment Phase (Week 1-6)
Withdrawal by Subject
|
1
|
0
|
0
|
|
OL Treatment ST Phase (From Week 7-16)
Study Terminated by Sponsor
|
0
|
14
|
0
|
|
OL Treatment ST Phase (From Week 7-16)
Other
|
0
|
1
|
0
|
|
OL Treatment ST Phase (From Week 7-16)
Missing Disposition Information
|
0
|
1
|
0
|
|
DB TM Phase (From Week 16-20)
Study Terminated by Sponsor
|
0
|
0
|
2
|
Baseline Characteristics
A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure
Baseline characteristics by cohort
| Measure |
OL (IN) Phase: Aticaprant 10 mg
n=47 Participants
During open label (OL) initial treatment (IN) phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 up to 6 weeks in addition to the ongoing antidepressant therapy selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake Inhibitors (SNRI). Participants who were responders (50 percent \[%\] or more reduction in the Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from the OL baseline \[Day 1, prior to first dose\] to the end of the OL initial treatment phase \[Week 6\]) to adjunctive aticaprant treatment entered the OL treatment stabilization (ST) phase. Participants who were non-responders were followed up for safety up to 2 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 12.58 • n=9 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Argentina
|
5 Participants
n=9 Participants
|
|
Region of Enrollment
Brazil
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
Bulgaria
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=9 Participants
|
|
Region of Enrollment
Mexico
|
7 Participants
n=9 Participants
|
|
Region of Enrollment
Poland
|
10 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140])Population: Randomized analysis set included all participants who were randomized to DB treatment maintenance phase.
Relapse is defined as any of the following: MADRS total score \>=22 for 2 consecutive assessments separated by 7 (+/-3) days and/or hospitalization or observation for worsening depression, or any clinically relevant event per clinical judgment suggestive of relapse of depressive illness, such as active suicidal ideation with intent or evidence of suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide attempt, completed suicide, or hospitalization for suicide prevention. Relapse date is defined by the second MADRS assessment. MADRS is a clinician-rated 10-item scale scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), with higher scores indicating more severe symptoms. C-SSRS is clinician-rated and reports severity and frequency of suicide-related ideation and behavior, categorized as no ideation/behavior (0), suicidal ideation (1 -5), or suicidal behavior (6 -10), with higher scores reflecting greater severity.
Outcome measures
| Measure |
DB Treatment Maintenance Phase: Aticaprant 10 mg
n=2 Participants
At Week 16, participants who were stable responders (50% or more reduction in the MADRS total score from the OL baseline in each of the last 2 consecutive assessments of the OL treatment stabilization phase (Week 14 and Week 16) with no MADRS total score \>=19 at these assessments) were randomized and the participants who did not meet criteria for stable response were sham randomized to receive aticaprant 10 mg tablet orally once daily from Day 113 until the required number of relapse events were achieved in addition to the ongoing antidepressant therapy. Participants who relapsed were then followed up for safety up to 2 weeks. Participants who had not relapsed and discontinued study intervention were followed up until they relapse or the study was terminated by the sponsor on Day 140.
|
|---|---|
|
Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse
|
NA days
The median and full range could not be calculated because no participants experienced a relapse.
|
Adverse Events
OL (IN) Phase: Aticaprant 10 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
OL (ST) Phase: Aticaprant 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
DB Treatment Maintenance Phase: Aticaprant 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OL (IN) Phase: Aticaprant 10 mg
n=47 participants at risk
During OL (IN) phase, participants received aticaprant 10 mg tablet orally once daily from Day 1 up to 6 weeks in addition to the ongoing antidepressant therapy selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake Inhibitors (SNRI). Participants who were responders (50 percent \[%\] or more reduction in the Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from the OL baseline \[Day 1, prior to first dose\] to the end of the OL initial treatment phase \[Week 6\]) to adjunctive aticaprant treatment entered the OL (ST) phase. Participants who were non-responders were followed up for safety up to 2 weeks.
|
OL (ST) Phase: Aticaprant 10 mg
n=18 participants at risk
Participants who were responders (50% or more reduction in the MADRS total score from the OL baseline \[Day 1, prior to first dose\] to the end of the OL (IN) phase \[Week 6\]) to adjunctive aticaprant treatment during OL (IN) phase entered the OL (ST) phase and continue to receive aticaprant 10 mg tablet orally once daily for additional 10 weeks (up to Week 16) in addition to the ongoing antidepressant therapy (SSRI/SNRI). At Week 16, participants entered into the DB (TM) phase. Participants who did not enter the DB (TM) phase were followed up for safety up to 2 weeks.
|
DB Treatment Maintenance Phase: Aticaprant 10 mg
n=2 participants at risk
At Week 16, participants who were stable responders (50% or more reduction in the MADRS total score from the OL baseline in each of the last 2 consecutive assessments of the OL treatment stabilization phase \[Week 14 and Week 16\] with no MADRS total score \>=19 at these assessments) were randomized and the participants who did not meet criteria for stable response were sham randomized to receive aticaprant 10 mg tablet orally once daily from Day 113 until the required number of relapse events were achieved in addition to the ongoing antidepressant therapy. Participants who relapsed were then followed up for safety up to 2 weeks. Participants who had not relapsed and discontinued study intervention were followed up until they relapse or the study was terminated by the sponsor on Day 140.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
3/47 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
5.6%
1/18 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/2 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.4%
3/47 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/18 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/2 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
|
Infections and infestations
Influenza
|
2.1%
1/47 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
5.6%
1/18 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/2 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/47 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
5.6%
1/18 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/2 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/47 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
5.6%
1/18 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/2 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
|
Nervous system disorders
Headache
|
8.5%
4/47 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/18 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/2 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.6%
5/47 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
11.1%
2/18 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
0.00%
0/2 • OL (IN) Arm: From Day 1 up to Week 8; OL (ST) Arm: From Week 7 up to Week 18; DB (TM) Arm: From Week 16 up to Week 20
OL (IN) phase: all subjects who had atleast 1 dose of study drug in OL (IN) phase and entered follow-up (FU) phase after OL (IN) phase. OL (ST) phase: subjects who had atleast 1 dose of study drug in OL ST phase and entered FU phase after OL (ST) phase. DB (TM) Phase: subjects randomised to DB (TM) phase and entered FU phase after DB (TM) Phase.
|
Additional Information
Executive Medical Director Neuro
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER