Trial Outcomes & Findings for Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults (NCT NCT05615220)
NCT ID: NCT05615220
Last Updated: 2025-11-25
Results Overview
Time to relapse defined as a loss of \>=50 percent (%) of the improvement experienced on the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) from Baseline to the last visit in the Open-Label Stabilization Period (Week 12), or initiation of additional medications to treat symptoms of Tourette's Disorder (TD), or requirement of hospitalization for worsening symptoms of TD in participants between the ages of \>= 6 and \<18 years for ecopipam compared to those receiving placebo during the double-blind, R/WD period. The YGTSS was a clinician-completed rating scale used to quantify overall tic severity in participants with TD as well as specific subdomains of tic number, frequency, intensity, complexity and interference. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a total tic score ranging from 0 to 50. Higher scores represented more severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
216 participants
Primary outcome timeframe
From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)
Results posted on
2025-11-25
Participant Flow
The multicenter study was conducted globally in the United States, Bulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Serbia, and Spain from 31 January 2023 to 04-February 2025.
Participants with a diagnosis of Tourette's Disorder were enrolled in this study to receive oral ecopipam in an Open-label Stabilization Period and a Double-blind Randomized Withdrawal (R/WD) Period and then followed for safety up to 30 days post-last dose.
Participant milestones
| Measure |
Open-label stabilization Period: Ecopipam 1.8 mg/kg/day
All participants in the open-label stabilization period received a target steady-state dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam hydrochloride \[HCl\]) tablets based on body weight, administered orally, once daily in the evening during a 4-week titration phase and further followed by an 8-week maintenance phase.
|
Double-blind R/WD Period: Ecopipam 1.8 mg/kg/day
Participants who met stabilization criteria were randomized to receive ecopipam 1.8 mg/kg/day (ecopipam HCl 2 mg/kg/day) orally once daily in the evening, up to 12 weeks in Double-blind R/WD Phase.
|
Double-blind R/WD Period: Placebo
Participants received matching placebo tablets, once daily, up to 12 weeks in Double-blind R/WD Phase. Participants randomized to placebo were tapered off ecopipam in a blinded fashion, in decrements of 22.4 milligrams per day (mg/day) (25 mg/day ecopipam HCl).
|
|---|---|---|---|
|
Open label stabilization Part (12 weeks)
STARTED
|
216
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
COMPLETED
|
104
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
NOT COMPLETED
|
112
|
0
|
0
|
|
Double Blind R/WD Part (12-24 weeks)
STARTED
|
0
|
51
|
53
|
|
Double Blind R/WD Part (12-24 weeks)
COMPLETED
|
0
|
21
|
13
|
|
Double Blind R/WD Part (12-24 weeks)
NOT COMPLETED
|
0
|
30
|
40
|
Reasons for withdrawal
| Measure |
Open-label stabilization Period: Ecopipam 1.8 mg/kg/day
All participants in the open-label stabilization period received a target steady-state dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam hydrochloride \[HCl\]) tablets based on body weight, administered orally, once daily in the evening during a 4-week titration phase and further followed by an 8-week maintenance phase.
|
Double-blind R/WD Period: Ecopipam 1.8 mg/kg/day
Participants who met stabilization criteria were randomized to receive ecopipam 1.8 mg/kg/day (ecopipam HCl 2 mg/kg/day) orally once daily in the evening, up to 12 weeks in Double-blind R/WD Phase.
|
Double-blind R/WD Period: Placebo
Participants received matching placebo tablets, once daily, up to 12 weeks in Double-blind R/WD Phase. Participants randomized to placebo were tapered off ecopipam in a blinded fashion, in decrements of 22.4 milligrams per day (mg/day) (25 mg/day ecopipam HCl).
|
|---|---|---|---|
|
Open label stabilization Part (12 weeks)
Failure to meet responder criteria
|
36
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Study end once relapsed goal met
|
21
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Adverse Event
|
33
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Withdrawal by Subject
|
6
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Non-compliance with study drug
|
1
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Physician Decision
|
1
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Lost to Follow-up
|
3
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Protocol Deviation
|
1
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Other
|
6
|
0
|
0
|
|
Open label stabilization Part (12 weeks)
Lack of Efficacy
|
4
|
0
|
0
|
|
Double Blind R/WD Part (12-24 weeks)
Relapsed
|
0
|
21
|
36
|
|
Double Blind R/WD Part (12-24 weeks)
Adverse Event
|
0
|
1
|
1
|
|
Double Blind R/WD Part (12-24 weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
|
Double Blind R/WD Part (12-24 weeks)
Study end once relapsed goal met
|
0
|
6
|
2
|
|
Double Blind R/WD Part (12-24 weeks)
Other
|
0
|
1
|
1
|
Baseline Characteristics
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Baseline characteristics by cohort
| Measure |
Open-label Stabilization Period: Ecopipam 1.8 mg/kg/Day
n=216 Participants
All participants in the open-label stabilization period who received a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam hydrochloride \[HCl\]) tablets based on body weight, administered orally, once daily in the evening during a 4-week titration phase and further followed by an 8-week maintenance phase.
|
|---|---|
|
Age, Continuous
|
16.3 years
STANDARD_DEVIATION 8.76 • n=9 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
186 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
196 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)Population: The modified intention-to-treat (mITT) set included all randomized participants who received at least 1 dose of study drug post-randomization.
Time to relapse defined as a loss of \>=50 percent (%) of the improvement experienced on the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) from Baseline to the last visit in the Open-Label Stabilization Period (Week 12), or initiation of additional medications to treat symptoms of Tourette's Disorder (TD), or requirement of hospitalization for worsening symptoms of TD in participants between the ages of \>= 6 and \<18 years for ecopipam compared to those receiving placebo during the double-blind, R/WD period. The YGTSS was a clinician-completed rating scale used to quantify overall tic severity in participants with TD as well as specific subdomains of tic number, frequency, intensity, complexity and interference. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a total tic score ranging from 0 to 50. Higher scores represented more severe symptoms.
Outcome measures
| Measure |
Double- Blind R/WD Period: Ecopipam 1.8 mg/kg/Day
n=43 Participants
Participants who met stabilization criteria were randomized to receive ecopipam 1.8 mg/kg/day (ecopipam HCl 2 mg/kg/day) orally once daily in the evening, up to 12 weeks in Double-Blind R/WD Phase.
|
Double- Blind R/WD Period: Placebo
n=47 Participants
Participants received matching placebo tablets, once daily, up to 12 weeks in Double-blind R/WD Phase. Participants randomized to placebo were tapered off ecopipam in a blinded fashion, in decrements of 22.4 milligrams per day (mg/day) (25 mg/day ecopipam HCl).
|
|---|---|---|
|
Time From Randomization to Relapse in Participants Greater Than and Equal to (>=) 6 and Less Than (<) 18 Years During the Double-Blind R/WD
|
NA weeks
Interval 4.1 to
Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to insufficient events within the treatment group.
|
4.0 weeks
Interval 2.4 to 6.1
|
SECONDARY outcome
Timeframe: From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)Population: The mITT Set included all randomized participants who received at least 1 dose of study drug post-randomization.
Time From Randomization (Week 12) to relapse defined as a loss of \>= 50% of the improvement experienced on the YGTSS-TTS from Baseline to the last visit in the Open-Label Stabilization Period (Week 12), or initiation of additional medications to treat symptoms of TD, or requirement of hospitalization for worsening symptoms of TD in all participants during the Double-Blind R/WD period for ecopipam compared to placebo. The YGTSS was a clinician-completed rating scale used to quantify overall tic severity in children and adults with TD as well as specific subdomains of tic number, frequency, intensity, complexity and interference. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a total tic score ranging from 0 to 50. Higher scores represented more severe symptoms.
Outcome measures
| Measure |
Double- Blind R/WD Period: Ecopipam 1.8 mg/kg/Day
n=51 Participants
Participants who met stabilization criteria were randomized to receive ecopipam 1.8 mg/kg/day (ecopipam HCl 2 mg/kg/day) orally once daily in the evening, up to 12 weeks in Double-Blind R/WD Phase.
|
Double- Blind R/WD Period: Placebo
n=53 Participants
Participants received matching placebo tablets, once daily, up to 12 weeks in Double-blind R/WD Phase. Participants randomized to placebo were tapered off ecopipam in a blinded fashion, in decrements of 22.4 milligrams per day (mg/day) (25 mg/day ecopipam HCl).
|
|---|---|---|
|
Time From Randomization to Relapse in All Participants During the Double-Blind R/WD Period
|
NA weeks
Interval 4.1 to
Here "NA" means median and upper limit of 95% confidence interval could not be estimated due to insufficient events within the treatment group.
|
4.0 weeks
Interval 2.4 to 6.1
|
Adverse Events
Open-label Stabilization Period: Ecopipam 1.8 mg/kg/Day
Serious events: 1 serious events
Other events: 140 other events
Deaths: 0 deaths
Double-blind R/WD Period: Ecopipam 1.8 mg/kg/Day
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Double- Blind R/WD Period: Placebo
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Stabilization Period: Ecopipam 1.8 mg/kg/Day
n=216 participants at risk
All participants in the open-label stabilization period were received a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam hydrochloride \[HCl\]) tablets based on body weight, administered orally, once daily in the evening during a 4-week titration phase and further followed by an 8-week maintenance phase.
|
Double-blind R/WD Period: Ecopipam 1.8 mg/kg/Day
n=51 participants at risk
Participants who met stabilization criteria were randomized to receive ecopipam 1.8 mg/kg/day (ecopipam HCl 2 mg/kg/day) orally once daily in the evening, up to 12 weeks in Double-blind R/WD Phase.
|
Double- Blind R/WD Period: Placebo
n=53 participants at risk
Participants received matching placebo tablets, once daily, up to 12 weeks in Double-blind R/WD Phase. Participants randomized to placebo were tapered off ecopipam in a blinded fashion, in decrements of 22.4 mg/day (25 mg/day ecopipam HCl).
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Tourette's disorder
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Open-label Stabilization Period: Ecopipam 1.8 mg/kg/Day
n=216 participants at risk
All participants in the open-label stabilization period were received a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam hydrochloride \[HCl\]) tablets based on body weight, administered orally, once daily in the evening during a 4-week titration phase and further followed by an 8-week maintenance phase.
|
Double-blind R/WD Period: Ecopipam 1.8 mg/kg/Day
n=51 participants at risk
Participants who met stabilization criteria were randomized to receive ecopipam 1.8 mg/kg/day (ecopipam HCl 2 mg/kg/day) orally once daily in the evening, up to 12 weeks in Double-blind R/WD Phase.
|
Double- Blind R/WD Period: Placebo
n=53 participants at risk
Participants received matching placebo tablets, once daily, up to 12 weeks in Double-blind R/WD Phase. Participants randomized to placebo were tapered off ecopipam in a blinded fashion, in decrements of 22.4 mg/day (25 mg/day ecopipam HCl).
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
6/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
6/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
5/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
6/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
6.5%
14/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.4%
3/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.9%
2/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
8/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
5.9%
3/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
5/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.8%
2/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.9%
4/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.8%
2/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
3/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.93%
2/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.93%
2/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.8%
2/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.9%
2/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Acute sinusitis
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.93%
2/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
4/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
11.1%
24/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.8%
19/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.9%
2/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
5.7%
3/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.93%
2/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
9.3%
20/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
7.4%
16/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
5.9%
3/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
9.4%
5/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Tic
|
6.9%
15/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.9%
2/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
3.7%
8/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Irritability
|
2.8%
6/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
2.3%
5/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
2.3%
5/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
1.9%
1/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.93%
2/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.9%
2/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
5.7%
3/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
3/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
3.9%
2/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.93%
2/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.46%
1/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/216 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
2.0%
1/51 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/53 • From the start of study drug administration up to end of double blind follow up period (up to Day 199)
Safety Set included all enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Drug Development and Medical Affairs
Emalex Biosciences Inc.
Phone: 773 343 0671
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place