Trial Outcomes & Findings for Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 (NCT NCT00878553)
NCT ID: NCT00878553
Last Updated: 2013-02-01
Results Overview
Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
Hours 3-7 (inclusive) after tablet ingestion
Results posted on
2013-02-01
Participant Flow
A total of 394 potential patients were screened by 8 U.S. investigative sites for enrollment into this study. Of these potential patients, 327 failed to complete the screening process.
5 of the 67 patients who were enrolled and randomized into this crossover sleep study did not complete it. The reasons for discontinuation were withdrawal of consent (2 patients), automobile accident(1), family emergency (1) and lost to follow up(1). One additional patient withdrew after completing the sleep study but prior to the PK substudy.
Participant milestones
| Measure |
Baseline: All Randomized Patients
The second screening visit consisted of 2 consecutive sleep laboratory nights of placebo pretreatment and full PSG recordings. The 67 patients who met entry criteria were then randomized to four treatment sequences with their screening night mean PSG parameters defined as their baseline.
This trial was comprised of 2 study periods: Sleep and Pharmacokinetic (PK). Each of 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence for the Sleep Study. For each of these treatment arms, two "double-dummy" tablets were administered at bedtime for two consecutive nights. An additional (third) dosing night allowed for pharmacokinetic characterization of the investigational zaleplon formulation. In this PK Substudy, patient's plasma concentrations were measured after a single dose in parallel group design.
|
Placebo (Sugar Pill)
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment. Two placebo tablets were administered orally at bedtime for two consecutive nights during the Sleep Study, after which patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned for the next treatment in their randomized sequence.
|
10 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|---|
|
Sleep Study
STARTED
|
67
|
0
|
0
|
0
|
0
|
|
Sleep Study
Number of Patients Receiving Placebo
|
66
|
0
|
0
|
0
|
0
|
|
Sleep Study
Number of Patients Receiving 10mg
|
65
|
0
|
0
|
0
|
0
|
|
Sleep Study
Number of Patients Receiving 15mg
|
65
|
0
|
0
|
0
|
0
|
|
Sleep Study
Number of Patients Receiving 20mg
|
65
|
0
|
0
|
0
|
0
|
|
Sleep Study
COMPLETED
|
62
|
0
|
0
|
0
|
0
|
|
Sleep Study
NOT COMPLETED
|
5
|
0
|
0
|
0
|
0
|
|
PK Study
STARTED
|
0
|
16
|
17
|
14
|
15
|
|
PK Study
COMPLETED
|
0
|
16
|
17
|
13
|
15
|
|
PK Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Baseline: All Randomized Patients
The second screening visit consisted of 2 consecutive sleep laboratory nights of placebo pretreatment and full PSG recordings. The 67 patients who met entry criteria were then randomized to four treatment sequences with their screening night mean PSG parameters defined as their baseline.
This trial was comprised of 2 study periods: Sleep and Pharmacokinetic (PK). Each of 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence for the Sleep Study. For each of these treatment arms, two "double-dummy" tablets were administered at bedtime for two consecutive nights. An additional (third) dosing night allowed for pharmacokinetic characterization of the investigational zaleplon formulation. In this PK Substudy, patient's plasma concentrations were measured after a single dose in parallel group design.
|
Placebo (Sugar Pill)
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment. Two placebo tablets were administered orally at bedtime for two consecutive nights during the Sleep Study, after which patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned for the next treatment in their randomized sequence.
|
10 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|---|
|
Sleep Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
|
Sleep Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Sleep Study
car accident
|
1
|
0
|
0
|
0
|
0
|
|
Sleep Study
family emergency
|
1
|
0
|
0
|
0
|
0
|
|
PK Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
Baseline characteristics by cohort
| Measure |
Sequence 1
n=16 Participants
10mg SKP-1041, 15mg SKP-1041, Placebo, 20mg SKP-1041
|
Sequence 2
n=17 Participants
Placebo, 10mg SKP-1041, 20mg SKP-1041, 15mg SKP-1041
|
Sequence 3
n=17 Participants
20mg SKP-1041, Placebo, 15mg SKP-1041, 10mg SKP-1041
|
Sequence 4
n=17 Participants
15mg SKP-1041, 10mg SKP-1041, 20mg SKP-1041, Placebo
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age Continuous
|
47.3 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 9.23 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 9.47 • n=4 Participants
|
46.1 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
17 participants
n=4 Participants
|
67 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Hours 3-7 (inclusive) after tablet ingestionPopulation: Efficacy analyses were performed on the Intention to Treat Population(all randomized patients).
Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)
|
-40.19 minutes
Standard Error 2.385
|
-48.79 minutes
Standard Error 2.420
|
-50.17 minutes
Standard Error 2.421
|
-49.34 minutes
Standard Error 2.422
|
SECONDARY outcome
Timeframe: Constantly throughout the 8 hour sleep periodPopulation: Intention to Treat population
Wake Time After Sleep Onset, measured in minutes over the full 8 hour polysomnographic recording period, is summarized by treatment group for each night during the Screening and Treatment Periods.
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
WASO 1-8
|
-44.65 Minutes
Standard Error 2.715 • Interval -50.005 to -39.293
|
-50.25 Minutes
Standard Error 2.755 • Interval -55.688 to -44.819
|
-51.56 Minutes
Standard Error 2.757 • Interval 56.999 to 46.123
|
-50.17 Minutes
Standard Error 2.757
|
SECONDARY outcome
Timeframe: hours 3-7 (inclusive) post-dosePopulation: Intention to Treat population (all randomized patients)
Total Sleep Time during hours 3-7 (inclusive) post-dose
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Total Sleep Time 3-7 Hours Post-dose
|
39.03 Minutes
Standard Error 2.365
|
47.86 Minutes
Standard Error 2.400
|
49.46 Minutes
Standard Error 2.401
|
49.18 Minutes
Standard Error 2.402
|
SECONDARY outcome
Timeframe: hours 3-7 (inclusive) post-dosePopulation: Intention to Treat dataset (all randomized patients)
Number of Awakenings After Sleep Onset during hours 3-7 post-dose (inclusive) as measured with PSG (polysomnography)
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)
|
-1.40 Number of awakenings
Standard Error 0.240
|
-1.96 Number of awakenings
Standard Error 0.244
|
-2.43 Number of awakenings
Standard Error 0.244
|
-2.19 Number of awakenings
Standard Error 0.244
|
SECONDARY outcome
Timeframe: 9 hours after tablet ingestionPopulation: All Efficacy Analyses were performed on the Intention to Treat (ITT) population (all randomized patients).
Subjective wake time after sleep onset sourced from the Morning Sleep Questionnaire self-assessment
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Subjective Wake Time After Sleep Onset (sWASO)
|
-14.05 minutes
Standard Error 4.873
|
-22.50 minutes
Standard Error 4.869
|
-12.68 minutes
Standard Error 4.937
|
-25.89 minutes
Standard Error 4.936
|
SECONDARY outcome
Timeframe: 9 hours after tablet ingestionPopulation: Intention to Treat population (all randomized patients)
Assessment of next-day residual cognitive effects. The Digit Symbol Substitution Test (DSST) explores attention and psychomotor speed. Given a code table displaying the correspondence between pairs of digits (from 1 to 9) and symbols, the patient filled in blank squares with the symbol that was paired with the digit displayed above the square. The patient was required to fill in as many squares as possible in 180 seconds.
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Digit Symbol Substitution Test
|
8.56 percentage change from mean baseline
Standard Error 1.434
|
9.26 percentage change from mean baseline
Standard Error 1.469
|
6.59 percentage change from mean baseline
Standard Error 1.523
|
9.95 percentage change from mean baseline
Standard Error 1.626
|
SECONDARY outcome
Timeframe: 9 hours post-dosePopulation: Intention to Treat population (all randomized patients)
Assessment of next day residual cognitive effects via testing immediate recall of numbers. The patient was given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score was the number of correct responses, where the digits were repeated correctly. One point was given for each correctly repeated string of digits. The maximum subscore in the Digits Forward was 16, and the maximum subscore in the Digits Backward was 14, for a total score of 30.
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=67 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Digit Span Test
|
0.23 units on a scale change from baseline
Standard Error 0.268
|
0.71 units on a scale change from baseline
Standard Error 0.256
|
0.40 units on a scale change from baseline
Standard Error 0.259
|
-0.02 units on a scale change from baseline
Standard Error 0.237
|
SECONDARY outcome
Timeframe: 9 hours after tablet ingestionPopulation: Safety population (patients exposed to that given treatment)
Self-assessment of next morning sedation. Patients answered the question "How alert do you feel?" via a 100mm scale on which 0mm indicated "very sleepy" and 100mm indicated "wide awake and alert".The VAS measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (in this case, sleepiness and alertness). Patients were asked to mark the point on the line that they felt represented their current state. The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked.
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=66 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=65 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=65 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
n=65 Participants
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Visual Analog Scale (Sedation)
|
3.48 mm change from baseline
Standard Error 2.195
|
3.83 mm change from baseline
Standard Error 1.818
|
3.55 mm change from baseline
Standard Error 2.422
|
4.96 mm change from baseline
Standard Error 2.058
|
SECONDARY outcome
Timeframe: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)Population: Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).
A detailed characterization of the Cmax (maximum plasma concentration of SKP-1041 zaleplon in ng/mL) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis).
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=170 Blood samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=130 Blood samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=150 Blood samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Cmax Pharmacokinetic (PK) Profile Characterization
|
17.9 ng/mL
Standard Error 1.3
|
25.3 ng/mL
Standard Error 2.9
|
34.4 ng/mL
Standard Error 4.2
|
—
|
SECONDARY outcome
Timeframe: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)Population: Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).
A detailed characterization of Cmax/Dose (ng/mL/mg) (maximum plasma zaleplon concentration normalized per dose) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics, geometric means and 90% confidence intervals were calculated for dose-normalized values of Cmax. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis).
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=170 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=130 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=150 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization
|
1.8 ng/mL/mg zaleplon
Standard Error 0.1
|
1.7 ng/mL/mg zaleplon
Standard Error 0.2
|
1.7 ng/mL/mg zaleplon
Standard Error 0.2
|
—
|
SECONDARY outcome
Timeframe: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)Population: Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).
A detailed characterization of Tmax (hour) (timepoint post-dose of maximum plasma zaleplon concentration) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis).
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=170 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=130 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=150 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Tmax Pharmacokinetic (PK) Profile Characterization
|
4 Hours post-dose
Standard Error 2.5
|
4 Hours post-dose
Standard Error 2.5
|
4 Hours post-dose
Standard Error 3.6
|
—
|
SECONDARY outcome
Timeframe: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)Population: Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).
A detailed characterization of the AUC (area under the concentration-time curve of SKP-1041 zaleplon) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics were calculated for AUC. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis).
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=170 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=130 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=150 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
AUC Pharmacokinetic (PK) Profile Characterization
|
56.5 ng x h/mL
Standard Error 3.9
|
77.4 ng x h/mL
Standard Error 5.6
|
135.3 ng x h/mL
Standard Error 22.0
|
—
|
SECONDARY outcome
Timeframe: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)Population: Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).
A detailed characterization of the AUC/Dose (ng\*h/mL/mg) \[Area under the concentration-time curve per Dose of SKP-1041 zaleplon\] for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis).
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=170 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=130 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=150 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization
|
5.36 ng*h/mL/mg
Standard Error 0.4
|
5.20 ng*h/mL/mg
Standard Error 0.4
|
6.76 ng*h/mL/mg
Standard Error 1.1
|
—
|
SECONDARY outcome
Timeframe: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)Population: Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).
A detailed characterization of the plasma Half-Life (t1/2 in hours) of SKP-1041 zaleplon the each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA)for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis).
Outcome measures
| Measure |
Placebo (Sugar Pill)
n=170 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
10 mg SKP-1041
n=130 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
15 mg SKP-1041
n=150 Blood Samples
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
20 mg SKP-1041
Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
|
|---|---|---|---|---|
|
Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization
|
1.52 hour
Standard Error 0.05
|
1.65 hour
Standard Error 0.17
|
1.47 hour
Standard Error 0.09
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
15mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
20mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=67 participants at risk
Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
|
10 mg
n=67 participants at risk
Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
|
15mg
n=67 participants at risk
Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
|
20mg
n=67 participants at risk
Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
3.0%
2/67 • Number of events 3 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Nervous system disorders
Sinus Headache
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
3.0%
2/67 • Number of events 2 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
General disorders
Infusion Site Pain
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
General disorders
Infusion Site Haematoma
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
General disorders
Chest Discomfort
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
General disorders
Chills
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
3.0%
2/67 • Number of events 2 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
General disorders
Chest Pain
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Cardiac disorders
Dizziness
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
1.5%
1/67 • Number of events 1 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
0.00%
0/67 • 6 months
21 patients (31.3%) reported at least 1 Treatment Emergent Adverse Event (TEAE), 6 of whom (9.0%) experienced at least 1 TEAE that was considered related to study medication. All TEAEs were mild or moderate in intensity. There were no Serious AEs,no TEAEs leading to discontinuation of study medication, and no TEAEs that led to death.
|
Additional Information
Dr. Christine Blumhardt, Chief Regulatory Officer
Somnus Therapeutics, Inc
Phone: 617-710-0928
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PROTOCOL CONFIDENTIALITY/COMPLIANCE STATEMENT: Investigators "...agree not to originate or use the name of Somnus Therapeutics, Inc and/or Zaleplon or SKP-1041, or any of its employees, in any publicity, news release, or other public announcement, written or oral, whether to the public, press, or otherwise, relating to this protocol, to any amendment hereto, or to the performance hereunder, without the prior written consent of Somnus Therapeutics, Inc." "SKP" refers to SkyePharma PLC
- Publication restrictions are in place
Restriction type: OTHER