Trial Outcomes & Findings for Dose Finding Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)(174007/P05805/MK-8777-003) (NCT NCT00610441)
NCT ID: NCT00610441
Last Updated: 2018-10-24
Results Overview
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.
COMPLETED
PHASE2
67 participants
Baseline (BL) and Day 7, Day 14, Day 21
2018-10-24
Participant Flow
Participant milestones
| Measure |
MK-8777 FD→PBO
Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
|
PBO→MK-8777 FD
Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
|
MK-8777 RD→PBO
Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
|
PBO→MK-8777 RD
Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
|
|---|---|---|---|---|
|
Treatment Period 1 - 3 Weeks
STARTED
|
15
|
16
|
18
|
18
|
|
Treatment Period 1 - 3 Weeks
COMPLETED
|
12
|
14
|
11
|
16
|
|
Treatment Period 1 - 3 Weeks
NOT COMPLETED
|
3
|
2
|
7
|
2
|
|
Placebo Washout Period - 2 Weeks
STARTED
|
12
|
14
|
11
|
16
|
|
Placebo Washout Period - 2 Weeks
COMPLETED
|
12
|
13
|
9
|
16
|
|
Placebo Washout Period - 2 Weeks
NOT COMPLETED
|
0
|
1
|
2
|
0
|
|
Treatment Period 2 - 3 Weeks
STARTED
|
12
|
13
|
9
|
16
|
|
Treatment Period 2 - 3 Weeks
COMPLETED
|
10
|
12
|
9
|
14
|
|
Treatment Period 2 - 3 Weeks
NOT COMPLETED
|
2
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
MK-8777 FD→PBO
Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
|
PBO→MK-8777 FD
Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
|
MK-8777 RD→PBO
Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
|
PBO→MK-8777 RD
Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
|
|---|---|---|---|---|
|
Treatment Period 1 - 3 Weeks
Adverse Event
|
1
|
1
|
4
|
1
|
|
Treatment Period 1 - 3 Weeks
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
Treatment Period 1 - 3 Weeks
Lost to Follow-up
|
1
|
1
|
1
|
0
|
|
Treatment Period 1 - 3 Weeks
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
|
Placebo Washout Period - 2 Weeks
Adverse Event
|
0
|
0
|
2
|
0
|
|
Placebo Washout Period - 2 Weeks
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Treatment Period 2 - 3 Weeks
Other
|
1
|
1
|
0
|
1
|
|
Treatment Period 2 - 3 Weeks
Adverse Event
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 - 3 Weeks
Lack of Efficacy
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Dose Finding Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)(174007/P05805/MK-8777-003)
Baseline characteristics by cohort
| Measure |
MK-8777 FD→PBO
n=15 Participants
Participants receive a fixed dose FD of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
|
PBO→MK-8777 FD
n=16 Participants
Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
|
MK-8777 RD→PBO
n=18 Participants
Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
|
PBO→MK-8777 RD
n=18 Participants
Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
37.0 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL) and Day 7, Day 14, Day 21Population: The Intent-to-Treat (ITT) population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline AISRS efficacy assessment. Results are reported by the study drug being administered at time of assessment and not by randomly assigned sequence.
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=25 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=30 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score
Change from BL at Day 7 (n=25, 26, 27, 30)
|
0.0 score on a scale
Standard Deviation 6.7
|
-3.7 score on a scale
Standard Deviation 7.1
|
-3.4 score on a scale
Standard Deviation 6.5
|
-3.9 score on a scale
Standard Deviation 7.6
|
|
Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score
Change from BL at Day 14 (n=25, 27, 27, 27)
|
-1.4 score on a scale
Standard Deviation 9.4
|
-7.3 score on a scale
Standard Deviation 8.6
|
-5.1 score on a scale
Standard Deviation 7.4
|
-4.6 score on a scale
Standard Deviation 7.7
|
|
Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score
Change from BL at Day 21 (n=22, 25, 24, 23)
|
-1.0 score on a scale
Standard Deviation 8.9
|
-7.5 score on a scale
Standard Deviation 10.8
|
-6.8 score on a scale
Standard Deviation 9.1
|
-3.3 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=25 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score
|
12.0 percentage of participants
|
41.0 percentage of participants
|
33.0 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.
The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the DSM-IV diagnostic symptoms for adults. Based on the clinician's rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score
|
0.0 percentage of participants
|
19.0 percentage of participants
|
19.0 percentage of participants
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 7 days after last dose of study drug (Up to 63 days)Population: The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=55 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=28 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=34 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants Who Experience At Least One Adverse Event (AE)
|
56.4 percentage of participants
|
71.4 percentage of participants
|
85.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to last dose of study drug (Up to 56 days)Population: The AST population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=55 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=28 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=34 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants Who Discontinue Study Drug Due to an AE
|
3.6 percentage of participants
|
3.6 percentage of participants
|
20.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 14-21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-S efficacy assessment.
The CGI-S is a 7-point clinician-rated scale for assessing the global severity of ADHD. Scores could range from 1=Normal, not at all ill to 7=Among the most extremely ill, with a higher score indicating more severe illness. Categorization was as follows: 1=Normal, not at all ill and Borderline mentally ill; 2=Mildly ill; 3=Moderately ill and 4=Markedly ill, Severely ill and Among the most extremely ill patients, with a higher category indicating more severe illness. Analysis of CGI-S was performed using a proportional odds model. For statistical analyses, CGI-S assessments were condensed to one assessment of severity per treatment period by taking the most severe score at the second and third visits within a treatment period.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=28 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores
Category 1
|
4.00 percentage of participants
|
3.70 percentage of participants
|
3.70 percentage of participants
|
7.41 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores
Category 2
|
20.00 percentage of participants
|
14.81 percentage of participants
|
11.11 percentage of participants
|
22.22 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores
Category 3
|
36.00 percentage of participants
|
55.56 percentage of participants
|
55.56 percentage of participants
|
51.85 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores
Category 4
|
40.00 percentage of participants
|
25.93 percentage of participants
|
29.63 percentage of participants
|
18.52 percentage of participants
|
SECONDARY outcome
Timeframe: Days 14-21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-I efficacy assessment.
The CGI-I is a 7-point clinician-rated scale for assessing the global improvement of ADHD. Scores could range from 1=Very much improved to 4=No change to 7=Very much worse, with a lower score indicating the most improvement. Analysis of CGI-I was performed using a proportional odds model. For statistical analyses, CGI-I assessments were condensed to one assessment of improvement per treatment period by taking the worst improvement score at the second and third visits within a treatment period.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=28 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Score of 1
|
0.0 percentage of participants
|
3.70 percentage of participants
|
3.70 percentage of participants
|
3.70 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Score of 2
|
12.00 percentage of participants
|
11.11 percentage of participants
|
3.70 percentage of participants
|
14.81 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Score of 3
|
20.00 percentage of participants
|
25.93 percentage of participants
|
40.74 percentage of participants
|
40.74 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Score of 4
|
64.00 percentage of participants
|
55.56 percentage of participants
|
48.15 percentage of participants
|
33.33 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Score of 5
|
4.00 percentage of participants
|
3.70 percentage of participants
|
3.70 percentage of participants
|
7.41 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Score of 6
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
|
Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores
Score of 7
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline ESS efficacy assessment.
The ESS is an 8-item scale used to assess sleepiness. The test consists of a list of 8 situations in which participants rate their tendency to become sleepy on a scale of 0=Would never doze to 3=High chance of dozing. The scores for each of the 8 situations are added to create a total score on a scale with a range from of 0 to 24. A higher score indicates a greater degree of sleepiness. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=25 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=30 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Score
Change from BL at Day 7 (n=25, 25, 27, 30)
|
-0.6 score on a scale
Standard Deviation 4.0
|
-1.1 score on a scale
Standard Deviation 2.5
|
-0.7 score on a scale
Standard Deviation 3.1
|
1.5 score on a scale
Standard Deviation 5.4
|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Score
Change from BL at Day 14 (n=25, 27, 27, 27)
|
-1.6 score on a scale
Standard Deviation 3.8
|
-1.7 score on a scale
Standard Deviation 2.3
|
-1.3 score on a scale
Standard Deviation 3.7
|
1.2 score on a scale
Standard Deviation 4.7
|
|
Change From Baseline in Epworth Sleepiness Scale (ESS) Score
Change from BL at Day 21 (n=22, 25, 24, 23)
|
-0.9 score on a scale
Standard Deviation 4.0
|
-0.8 score on a scale
Standard Deviation 3.8
|
-0.7 score on a scale
Standard Deviation 4.6
|
1.1 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline PSQI efficacy assessment.
The PSQI is a participant-rated scale to assess the quality of sleep. The PSQI consists of 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score can range from 0=better (i.e., 0 times per month) to 3=worse (i.e., 3 or more times per week). The sum of these 7 component scores yields one total score with a range of 0 (better) to 21 (worse). A total PSQI score \<=5 is associated with good sleep quality; a total score \>5 is associated with poor sleep quality. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=25 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=30 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
Change from BL at Day 7 (N=25, 26, 27, 30)
|
-0.7 score on a scale
Standard Deviation 1.7
|
-0.6 score on a scale
Standard Deviation 2.0
|
0.6 score on a scale
Standard Deviation 3.2
|
-0.4 score on a scale
Standard Deviation 2.2
|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
Change from BL at Day 14 (N=25, 27, 27, 27)
|
-0.5 score on a scale
Standard Deviation 1.7
|
-0.1 score on a scale
Standard Deviation 3.6
|
-0.8 score on a scale
Standard Deviation 2.3
|
-0.1 score on a scale
Standard Deviation 2.4
|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
Change from BL at Day 21 (n=21, 25, 24, 23)
|
-1.1 score on a scale
Standard Deviation 2.5
|
-0.7 score on a scale
Standard Deviation 2.7
|
-0.4 score on a scale
Standard Deviation 2.1
|
-0.3 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline QIDS-C efficacy assessment.
The QIDS-C is a clinician-administered rating scale to measure the severity of depressive symptoms within the 9 DSM-IV major depression disorder symptom (MDD) domains: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. There is one score (0=none to 3=severe) for each of the of the 9 domains. The total score is obtained by adding the scores for each of the 9 symptom domains. QIDS-C total scores can range from 0 to 27, with a higher score indicating more severe depression. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=25 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=30 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score
Change from BL at Day 7 (n=25, 26, 27, 30)
|
0.2 score on a scale
Standard Deviation 1.7
|
-0.1 score on a scale
Standard Deviation 2.3
|
-0.1 score on a scale
Standard Deviation 2.2
|
-0.3 score on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score
Change from BL at Day 14 (n=25, 27, 27, 27)
|
0.3 score on a scale
Standard Deviation 2.9
|
0.0 score on a scale
Standard Deviation 2.9
|
-0.3 score on a scale
Standard Deviation 1.4
|
0.3 score on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score
Change from BL at Day 21 (n=22, 25, 24, 23)
|
0.1 score on a scale
Standard Deviation 2.6
|
0.5 score on a scale
Standard Deviation 2.1
|
-0.5 score on a scale
Standard Deviation 1.9
|
0.1 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline and Day 7, Day 14, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline TASS efficacy assessment.
The TASS is a participant-administered scale to assess study drug effects in the evening. Participants respond to 18 questions about ADHD symptoms, with scores from 0=Not at all to 3=Severe. Total scores can range from 0 to 54, with a higher score indicating more severe ADHD symtoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=20 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=23 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=22 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=25 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score
Change from BL at Day 7 (n=20, 23, 22, 25)
|
0.3 score on a scale
Standard Deviation 6.5
|
-1.1 score on a scale
Standard Deviation 6.5
|
0.0 score on a scale
Standard Deviation 6.2
|
-1.5 score on a scale
Standard Deviation 4.7
|
|
Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score
Change from BL at Day 14 (n=20, 22, 20, 25)
|
-0.4 score on a scale
Standard Deviation 8.1
|
-2.2 score on a scale
Standard Deviation 7.8
|
-2.4 score on a scale
Standard Deviation 6.2
|
-1.7 score on a scale
Standard Deviation 6.5
|
|
Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score
Change from BL at Day 21 (n=15, 23, 21, 19)
|
-2.2 score on a scale
Standard Deviation 7.3
|
-3.0 score on a scale
Standard Deviation 8.7
|
-2.9 score on a scale
Standard Deviation 8.4
|
-1.3 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for cognitive flexibility.
Cognition was assessed by a computerized cognitive testing (©CNS Vital Signs, Chapel Hill, NC) battery consisting of neuropsychological tests that measure the cognitive domain of cognitive flexibility (score range: -200 to 200), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Cognitive Flexibility
BL (n=27, 27, 26, 32)
|
48.0 score on a scale
Standard Deviation 18.1
|
49.5 score on a scale
Standard Deviation 17.9
|
47.1 score on a scale
Standard Deviation 19.5
|
46.5 score on a scale
Standard Deviation 20.5
|
|
Computerized Cognition Assessment: Cognitive Flexibility
Day 21 (n=21, 25, 25, 23)
|
50.3 score on a scale
Standard Deviation 14.1
|
49.2 score on a scale
Standard Deviation 20.7
|
50.9 score on a scale
Standard Deviation 14.8
|
50.7 score on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for complex attention.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of complex attention (score range: 0 to 250), with a lower score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Complex Attention
BL (n=27, 27, 26, 32)
|
11.9 score on a scale
Standard Deviation 22.0
|
17.3 score on a scale
Standard Deviation 32.0
|
13.5 score on a scale
Standard Deviation 26.1
|
10.8 score on a scale
Standard Deviation 15.9
|
|
Computerized Cognition Assessment: Complex Attention
Day 21 (n=21, 25, 25, 23)
|
18.1 score on a scale
Standard Deviation 39.0
|
12.8 score on a scale
Standard Deviation 14.4
|
9.6 score on a scale
Standard Deviation 15.5
|
16.0 score on a scale
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for composite memory.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of composite memory (score range: -120 to 120), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Composite Memory
BL (n=27, 27, 26, 32)
|
92.5 score on a scale
Standard Deviation 8.7
|
92.6 score on a scale
Standard Deviation 10.5
|
96.9 score on a scale
Standard Deviation 9.7
|
96.7 score on a scale
Standard Deviation 9.4
|
|
Computerized Cognition Assessment: Composite Memory
Day 21 (n=21, 25, 25, 23)
|
98.8 score on a scale
Standard Deviation 10.2
|
93.1 score on a scale
Standard Deviation 9.5
|
96.0 score on a scale
Standard Deviation 11.8
|
96.0 score on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for executive functioning.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of executive functioning (score range: -200 to 200), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Executive Functioning
BL (n=27, 27, 26, 32)
|
49.8 score on a scale
Standard Deviation 17.1
|
50.9 score on a scale
Standard Deviation 17.7
|
49.3 score on a scale
Standard Deviation 19.5
|
48.1 score on a scale
Standard Deviation 20.3
|
|
Computerized Cognition Assessment: Executive Functioning
Day 21 (n=21, 25, 25, 23)
|
52.0 score on a scale
Standard Deviation 13.7
|
50.9 score on a scale
Standard Deviation 19.7
|
53.1 score on a scale
Standard Deviation 14.0
|
52.5 score on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for speed of processing.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of speed of processing (score range: -1000 to 200), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Speed of Processing
BL (n=27, 27, 26, 32)
|
63.8 score on a scale
Standard Deviation 16.1
|
64.3 score on a scale
Standard Deviation 15.8
|
58.0 score on a scale
Standard Deviation 10.6
|
58.9 score on a scale
Standard Deviation 8.0
|
|
Computerized Cognition Assessment: Speed of Processing
Day 21 (n=21, 25, 25, 23)
|
64.1 score on a scale
Standard Deviation 9.1
|
63.5 score on a scale
Standard Deviation 15.5
|
60.9 score on a scale
Standard Deviation 10.6
|
59.9 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reaction time.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reaction time (lowest time possible is 0 msec), with a lower reaction time indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Reaction Time
BL (n=27, 27, 26, 32)
|
646.7 msec
Standard Deviation 87.3
|
645.6 msec
Standard Deviation 81.6
|
653.1 msec
Standard Deviation 118.8
|
673.8 msec
Standard Deviation 124.1
|
|
Computerized Cognition Assessment: Reaction Time
Day 21 (n=21, 25, 25, 23)
|
634.4 msec
Standard Deviation 74.6
|
621.7 msec
Standard Deviation 152.0
|
646.7 msec
Standard Deviation 139.3
|
642.4 msec
Standard Deviation 111.5
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reasoning.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reasoning (score range: -15 to 15), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Reasoning
BL (n=27, 27, 26, 32)
|
6.6 score on a scale
Standard Deviation 4.6
|
7.7 score on a scale
Standard Deviation 4.6
|
5.9 score on a scale
Standard Deviation 3.3
|
7.5 score on a scale
Standard Deviation 3.3
|
|
Computerized Cognition Assessment: Reasoning
Day 21 (n=21, 25, 25, 23)
|
7.9 score on a scale
Standard Deviation 3.3
|
8.2 score on a scale
Standard Deviation 3.7
|
7.4 score on a scale
Standard Deviation 4.1
|
7.1 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for sustained attention.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of sustained attention (score range -120 to 120), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Sustained Attention
BL (n=27, 27, 26, 32)
|
26.1 score on a scale
Standard Deviation 12.0
|
28.9 score on a scale
Standard Deviation 7.9
|
27.0 score on a scale
Standard Deviation 8.2
|
28.4 score on a scale
Standard Deviation 8.9
|
|
Computerized Cognition Assessment: Sustained Attention
Day 21 (n=21, 25, 25, 23)
|
29.5 score on a scale
Standard Deviation 5.6
|
25.5 score on a scale
Standard Deviation 9.3
|
29.7 score on a scale
Standard Deviation 7.6
|
27.3 score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for verbal memory.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of verbal memory (score range: -60 to 60), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Verbal Memory
BL (n=27, 27, 26, 32)
|
49.4 score on a scale
Standard Deviation 4.8
|
48.7 score on a scale
Standard Deviation 5.7
|
50.8 score on a scale
Standard Deviation 5.9
|
51.5 score on a scale
Standard Deviation 4.9
|
|
Computerized Cognition Assessment: Verbal Memory
Day 21 (n=21, 25, 25, 23)
|
52.4 score on a scale
Standard Deviation 5.0
|
51.3 score on a scale
Standard Deviation 5.2
|
51.2 score on a scale
Standard Deviation 6.1
|
50.2 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for visual memory.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of visual memory (score range: -60 to 60), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Visual Memory
BL (n=27, 27, 26, 32)
|
43.0 score on a scale
Standard Deviation 6.4
|
43.8 score on a scale
Standard Deviation 6.3
|
46.2 score on a scale
Standard Deviation 5.8
|
45.3 score on a scale
Standard Deviation 6.0
|
|
Computerized Cognition Assessment: Visual Memory
Day 21 (n=21, 25, 25, 23)
|
46.3 score on a scale
Standard Deviation 6.8
|
41.8 score on a scale
Standard Deviation 6.7
|
44.8 score on a scale
Standard Deviation 7.6
|
45.9 score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Baseline, Day 21Population: The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for working memory.
Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of working memory (score range: -48 to 48), with a higher score indicating better cognition.
Outcome measures
| Measure |
Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD
n=27 Participants
Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
|
Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=26 Participants
Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
|
MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD
n=32 Participants
Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
|
|---|---|---|---|---|
|
Computerized Cognition Assessment: Working Memory
BL (n=27, 27, 26, 32)
|
9.8 score on a scale
Standard Deviation 6.3
|
10.2 score on a scale
Standard Deviation 5.0
|
10.0 score on a scale
Standard Deviation 5.1
|
9.6 score on a scale
Standard Deviation 4.9
|
|
Computerized Cognition Assessment: Working Memory
Day 21 (n=21, 25, 25, 23)
|
10.0 score on a scale
Standard Deviation 4.1
|
8.5 score on a scale
Standard Deviation 5.2
|
10.3 score on a scale
Standard Deviation 5.1
|
8.9 score on a scale
Standard Deviation 6.0
|
Adverse Events
Placebo
MK-8777 100mg
MK-8777 100-300mg
Serious adverse events
| Measure |
Placebo
n=55 participants at risk
Participants receive placebo BID for up to 5 weeks.
|
MK-8777 100mg
n=28 participants at risk
Participants receive a fixed dose of MK-8777 100 mg BID for up to 3 weeks.
|
MK-8777 100-300mg
n=34 participants at risk
Participants receive rising doses of MK-8777 100-300 mg BID for up to 3 weeks.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/34 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
Other adverse events
| Measure |
Placebo
n=55 participants at risk
Participants receive placebo BID for up to 5 weeks.
|
MK-8777 100mg
n=28 participants at risk
Participants receive a fixed dose of MK-8777 100 mg BID for up to 3 weeks.
|
MK-8777 100-300mg
n=34 participants at risk
Participants receive rising doses of MK-8777 100-300 mg BID for up to 3 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/55 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/55 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Nausea
|
10.9%
6/55 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
14.3%
4/28 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
55.9%
19/34 • Number of events 24 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
General disorders
Fatigue
|
5.5%
3/55 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
8.8%
3/34 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
4/55 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
2.9%
1/34 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/55 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
7.1%
2/28 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/34 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Nervous system disorders
Dizziness
|
3.6%
2/55 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
10.7%
3/28 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
44.1%
15/34 • Number of events 17 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Nervous system disorders
Headache
|
12.7%
7/55 • Number of events 7 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
10.7%
3/28 • Number of events 4 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
32.4%
11/34 • Number of events 13 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Nervous system disorders
Somnolence
|
9.1%
5/55 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
8.8%
3/34 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/55 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
3.6%
1/28 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Psychiatric disorders
Insomnia
|
9.1%
5/55 • Number of events 5 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
10.7%
3/28 • Number of events 3 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
2.9%
1/34 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
|
Psychiatric disorders
Thinking abnormal
|
1.8%
1/55 • Number of events 1 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
0.00%
0/28 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
5.9%
2/34 • Number of events 2 • Up to 30 days after last dose of study drug (Up to 12 weeks).
AEs are reported by study drug taken at time of event and not by randomly assigned sequence.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60