Trial Outcomes & Findings for The Efficacy and Safety of PRC-063 in Adult ADHD Patients (NCT NCT02139124)
NCT ID: NCT02139124
Last Updated: 2019-05-07
Results Overview
Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-05-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo Arm
Placebo: Oral placebo capsule
|
PRC-063 25 mg
PRC-063 25 mg
PRC-063 25 mg: Oral 25 mg capsule - active
|
PRC-063 45 mg
PRC-063 45 mg
PRC-063 45 mg: Oral 45 mg capsule - active
|
PRC-063 70 mg
PRC-063 70 mg
PRC-063 70 mg: Oral 70 mg capsule - active
|
PRC-063 100 mg
PRC-063 100 mg
PRC-063 100 mg: Oral 100 mg capsule - active
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
73
|
73
|
74
|
|
Overall Study
COMPLETED
|
69
|
73
|
69
|
61
|
61
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
4
|
12
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Placebo Arm
Placebo: Oral placebo capsule
|
PRC-063 25 mg
PRC-063 25 mg
PRC-063 25 mg: Oral 25 mg capsule - active
|
PRC-063 45 mg
PRC-063 45 mg
PRC-063 45 mg: Oral 45 mg capsule - active
|
PRC-063 70 mg
PRC-063 70 mg
PRC-063 70 mg: Oral 70 mg capsule - active
|
PRC-063 100 mg
PRC-063 100 mg
PRC-063 100 mg: Oral 100 mg capsule - active
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
2
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
non-compliant
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
incarceration
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
subject moved
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
0
|
5
|
4
|
Baseline Characteristics
The Efficacy and Safety of PRC-063 in Adult ADHD Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=78 Participants
Placebo Arm
Placebo: Oral placebo capsule
|
PRC-063 25 mg
n=77 Participants
PRC-063 25 mg
PRC-063 25 mg: Oral 25 mg capsule - active
|
PRC-063 45 mg
n=73 Participants
PRC-063 45 mg
PRC-063 45 mg: Oral 45 mg capsule - active
|
PRC-063 70 mg
n=73 Participants
PRC-063 70 mg
PRC-063 70 mg: Oral 70 mg capsule - active
|
PRC-063 100 mg
n=74 Participants
PRC-063 100 mg
PRC-063 100 mg: Oral 100 mg capsule - active
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 12.48 • n=7 Participants
|
36.0 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 11.19 • n=4 Participants
|
35.3 years
STANDARD_DEVIATION 11.68 • n=21 Participants
|
36.0 years
STANDARD_DEVIATION 11.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
198 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
177 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
318 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
317 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The Full Analysis population consists of all randomized subjects who receive any amount of study medication and who have any ADHD-5-Rating Scale assessments.
Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms.
Outcome measures
| Measure |
PRC-063 25 mg
n=77 Participants
PRC-063 25 mg
PRC-063 25 mg: Oral 25 mg capsule - active
|
PRC-063 45 mg
n=73 Participants
PRC-063 45 mg
PRC-063 45 mg: Oral 45 mg capsule - active
|
PRC-063 70 mg
n=73 Participants
PRC-063 70 mg
PRC-063 70 mg: Oral 70 mg capsule - active
|
PRC-063 100 mg
n=74 Participants
PRC-063 100 mg
PRC-063 100 mg: Oral 100 mg capsule - active
|
0 mg/Day
n=78 Participants
Placebo
|
|---|---|---|---|---|---|
|
Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score
|
24.2 units on a scale
Standard Deviation 11.88
|
19.9 units on a scale
Standard Deviation 12.45
|
24.0 units on a scale
Standard Deviation 11.25
|
18.7 units on a scale
Standard Deviation 11.48
|
26.1 units on a scale
Standard Deviation 11.99
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
PRC-063 25 mg
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
PRC-063 45 mg
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
PRC-063 70 mg
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
PRC-063 100 mg
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=78 participants at risk
Placebo Arm
Placebo: Oral placebo capsule
|
PRC-063 25 mg
n=77 participants at risk
PRC-063 25 mg
PRC-063 25 mg: Oral 25 mg capsule - active
|
PRC-063 45 mg
n=73 participants at risk
PRC-063 45 mg
PRC-063 45 mg: Oral 45 mg capsule - active
|
PRC-063 70 mg
n=73 participants at risk
PRC-063 70 mg
PRC-063 70 mg: Oral 70 mg capsule - active
|
PRC-063 100 mg
n=74 participants at risk
PRC-063 100 mg
PRC-063 100 mg: Oral 100 mg capsule - active
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
General disorders
Feeling jittery
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Infections and infestations
cellulitis
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Injury, poisoning and procedural complications
muscle strain
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine cancer
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
headache
|
2.6%
2/78 • Number of events 2 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Psychiatric disorders
anxiety
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
emotional disorder
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
insomnia
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 3 • double blind phase
|
|
Psychiatric disorders
mood altered
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
psychotic disorder
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Renal and urinary disorders
calculus urinary
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
Other adverse events
| Measure |
Placebo
n=78 participants at risk
Placebo Arm
Placebo: Oral placebo capsule
|
PRC-063 25 mg
n=77 participants at risk
PRC-063 25 mg
PRC-063 25 mg: Oral 25 mg capsule - active
|
PRC-063 45 mg
n=73 participants at risk
PRC-063 45 mg
PRC-063 45 mg: Oral 45 mg capsule - active
|
PRC-063 70 mg
n=73 participants at risk
PRC-063 70 mg
PRC-063 70 mg: Oral 70 mg capsule - active
|
PRC-063 100 mg
n=74 participants at risk
PRC-063 100 mg
PRC-063 100 mg: Oral 100 mg capsule - active
|
|---|---|---|---|---|---|
|
Cardiac disorders
conduction disorder
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Cardiac disorders
palpitations
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
4.1%
3/73 • Number of events 4 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Cardiac disorders
tachycardia
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
2.7%
2/74 • Number of events 2 • double blind phase
|
|
Ear and labyrinth disorders
ear discomfort
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Eye disorders
blepharospasm
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Eye disorders
dry eye
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Eye disorders
vision blurred
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
2.7%
2/74 • Number of events 2 • double blind phase
|
|
Gastrointestinal disorders
abdominal discomfort
|
2.6%
2/78 • Number of events 2 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
4.1%
3/74 • Number of events 3 • double blind phase
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Gastrointestinal disorders
constipation
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Gastrointestinal disorders
diarrhoea
|
1.3%
1/78 • Number of events 1 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
2.7%
2/74 • Number of events 3 • double blind phase
|
|
Gastrointestinal disorders
dry mouth
|
1.3%
1/78 • Number of events 1 • double blind phase
|
6.5%
5/77 • Number of events 5 • double blind phase
|
6.8%
5/73 • Number of events 5 • double blind phase
|
6.8%
5/73 • Number of events 5 • double blind phase
|
12.2%
9/74 • Number of events 9 • double blind phase
|
|
Gastrointestinal disorders
dyspepsia
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Gastrointestinal disorders
lip dry
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Gastrointestinal disorders
lip swelling
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Gastrointestinal disorders
nausea
|
1.3%
1/78 • Number of events 1 • double blind phase
|
2.6%
2/77 • Number of events 2 • double blind phase
|
5.5%
4/73 • Number of events 5 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
10.8%
8/74 • Number of events 9 • double blind phase
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
General disorders
chest discomfort
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 2 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
General disorders
energy increased
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
General disorders
fatigue
|
3.8%
3/78 • Number of events 3 • double blind phase
|
0.00%
0/77 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
8.1%
6/74 • Number of events 6 • double blind phase
|
|
General disorders
feeling jittery
|
1.3%
1/78 • Number of events 1 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
8.2%
6/73 • Number of events 7 • double blind phase
|
4.1%
3/74 • Number of events 3 • double blind phase
|
|
General disorders
pain
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
General disorders
pyrexia
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
General disorders
thirst
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Investigations
alanine aminotransferase
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Investigations
blood creatine phosphokinase
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Investigations
blood pressure diastolic increased
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Investigations
blood pressure increased
|
0.00%
0/78 • double blind phase
|
2.6%
2/77 • Number of events 2 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Investigations
electrocardiogram repolarisation abnormality
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Investigations
heart rate increased
|
2.6%
2/78 • Number of events 2 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Investigations
weight decreased
|
1.3%
1/78 • Number of events 1 • double blind phase
|
2.6%
2/77 • Number of events 2 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
5.4%
4/74 • Number of events 4 • double blind phase
|
|
Metabolism and nutrition disorders
decreased appetite
|
1.3%
1/78 • Number of events 1 • double blind phase
|
3.9%
3/77 • Number of events 3 • double blind phase
|
6.8%
5/73 • Number of events 5 • double blind phase
|
15.1%
11/73 • Number of events 11 • double blind phase
|
18.9%
14/74 • Number of events 14 • double blind phase
|
|
Metabolism and nutrition disorders
increased appetite
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Musculoskeletal and connective tissue disorders
muscle tightness
|
0.00%
0/78 • double blind phase
|
2.6%
2/77 • Number of events 2 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Musculoskeletal and connective tissue disorders
muscle twitching
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
1.3%
1/78 • Number of events 1 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Musculoskeletal and connective tissue disorders
temporomandibular joint syndrome
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
balance disorder
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
disturbance in attention
|
2.6%
2/78 • Number of events 2 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
dizziness
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
4.1%
3/74 • Number of events 3 • double blind phase
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
headache
|
10.3%
8/78 • Number of events 9 • double blind phase
|
9.1%
7/77 • Number of events 8 • double blind phase
|
19.2%
14/73 • Number of events 18 • double blind phase
|
20.5%
15/73 • Number of events 15 • double blind phase
|
12.2%
9/74 • Number of events 9 • double blind phase
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Nervous system disorders
lethargy
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
mental impairment
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
2.7%
2/74 • Number of events 3 • double blind phase
|
|
Nervous system disorders
restless leg syndrome
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
sedation
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/74 • Number of events 2 • double blind phase
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Nervous system disorders
Somnolence
|
2.6%
2/78 • Number of events 2 • double blind phase
|
2.6%
2/77 • Number of events 2 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
4.1%
3/74 • Number of events 3 • double blind phase
|
|
Nervous system disorders
Tension headache
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Nervous system disorders
tremor
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Psychiatric disorders
abnormal dreams
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Psychiatric disorders
affect lability
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
agitation
|
0.00%
0/78 • double blind phase
|
2.6%
2/77 • Number of events 2 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Nervous system disorders
anxiety
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
bruxism
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
2.7%
2/73 • Number of events 2 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Psychiatric disorders
confusional state
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Psychiatric disorders
emotional disorder
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
2.7%
2/74 • Number of events 2 • double blind phase
|
|
Psychiatric disorders
initial insomnia
|
1.3%
1/78 • Number of events 1 • double blind phase
|
3.9%
3/77 • Number of events 3 • double blind phase
|
8.2%
6/73 • Number of events 6 • double blind phase
|
5.5%
4/73 • Number of events 4 • double blind phase
|
6.8%
5/74 • Number of events 6 • double blind phase
|
|
Psychiatric disorders
insomnia
|
2.6%
2/78 • Number of events 2 • double blind phase
|
15.6%
12/77 • Number of events 12 • double blind phase
|
11.0%
8/73 • Number of events 9 • double blind phase
|
15.1%
11/73 • Number of events 12 • double blind phase
|
18.9%
14/74 • Number of events 16 • double blind phase
|
|
Psychiatric disorders
irritability
|
3.8%
3/78 • Number of events 3 • double blind phase
|
9.1%
7/77 • Number of events 7 • double blind phase
|
6.8%
5/73 • Number of events 5 • double blind phase
|
2.7%
2/73 • Number of events 3 • double blind phase
|
2.7%
2/74 • Number of events 2 • double blind phase
|
|
Psychiatric disorders
middle insomnia
|
1.3%
1/78 • Number of events 1 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
2.7%
2/74 • Number of events 2 • double blind phase
|
|
Psychiatric disorders
mood altered
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
mood swings
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Psychiatric disorders
orgasm abnormal
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
psychotic disorder
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Psychiatric disorders
restlessness
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
4.1%
3/73 • Number of events 4 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Psychiatric disorders
sleep disorder
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
1.4%
1/74 • Number of events 2 • double blind phase
|
|
Psychiatric disorders
terminal insomnia
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Renal and urinary disorders
pollakiuria
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Reproductive system and breast disorders
amenorrhoea
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 2 • double blind phase
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
1.3%
1/78 • Number of events 1 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Respiratory, thoracic and mediastinal disorders
nasal dryness
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
1.3%
1/78 • Number of events 1 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Skin and subcutaneous tissue disorders
acne
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
2.7%
2/74 • Number of events 2 • double blind phase
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/74 • Number of events 1 • double blind phase
|
|
Vascular disorders
flushing
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Vascular disorders
hot flush
|
0.00%
0/78 • double blind phase
|
0.00%
0/77 • double blind phase
|
0.00%
0/73 • double blind phase
|
1.4%
1/73 • Number of events 1 • double blind phase
|
0.00%
0/74 • double blind phase
|
|
Vascular disorders
hypertension
|
0.00%
0/78 • double blind phase
|
1.3%
1/77 • Number of events 1 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/73 • double blind phase
|
0.00%
0/74 • double blind phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place