Trial Outcomes & Findings for 6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777) (NCT NCT00265343)
NCT ID: NCT00265343
Last Updated: 2022-02-09
Results Overview
Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 \[best\]-96 \[worst\].
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
306 participants
Primary outcome timeframe
Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Asenapine
5-10 mg twice daily (bid) sublingual (SL)
|
Olanzapine
5-20 mg daily (QD) orally (PO)
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
172
|
|
Overall Study
COMPLETED
|
113
|
153
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
| Measure |
Asenapine
5-10 mg twice daily (bid) sublingual (SL)
|
Olanzapine
5-20 mg daily (QD) orally (PO)
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
9
|
|
Overall Study
Other
|
8
|
3
|
Baseline Characteristics
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)
Baseline characteristics by cohort
| Measure |
Asenapine
n=134 Participants
5-10 mg twice daily (bid) sublingual (SL)
|
Olanzapine
n=172 Participants
5-20 mg daily (QD) orally (PO)
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)Population: Intent-to-treat population
Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 \[best\]-96 \[worst\].
Outcome measures
| Measure |
Asenapine
n=122 Participants
5-10 mg twice daily (bid) sublingual (SL)
|
Olanzapine
n=157 Participants
5-20 mg daily (QD) orally (PO)
|
|---|---|---|
|
Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
|
-16.9 Units on a Scale
Standard Error 0.98
|
-15.4 Units on a Scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)Population: Intent-to-treat population
Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 \[worst\]-126 \[best\].
Outcome measures
| Measure |
Asenapine
n=122 Participants
5-10 mg twice daily (bid) sublingual (SL)
|
Olanzapine
n=157 Participants
5-20 mg daily (QD) orally (PO)
|
|---|---|---|
|
Change in Quality of Life Measured by Quality of Life Scale (QLS)
|
18.7 Units on a Scale
Standard Error 1.64
|
16.4 Units on a Scale
Standard Error 1.4
|
Adverse Events
Asenapine
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
Olanzapine
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Asenapine
n=134 participants at risk
|
Olanzapine
n=172 participants at risk
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/134
|
0.58%
1/172 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/134
|
0.58%
1/172 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/134
|
0.58%
1/172 • Number of events 1
|
|
Infections and infestations
Salmonellosis
|
0.75%
1/134 • Number of events 1
|
0.00%
0/172
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
1/134 • Number of events 1
|
0.00%
0/172
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.75%
1/134 • Number of events 1
|
0.00%
0/172
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/134
|
0.58%
1/172 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.75%
1/134 • Number of events 1
|
0.00%
0/172
|
|
Psychiatric disorders
Anxiety
|
0.75%
1/134 • Number of events 1
|
0.00%
0/172
|
|
Psychiatric disorders
Nervousness
|
0.75%
1/134 • Number of events 3
|
0.00%
0/172
|
|
Psychiatric disorders
Psychotic disorder
|
0.75%
1/134 • Number of events 1
|
0.00%
0/172
|
|
Psychiatric disorders
Schizophrenia
|
3.0%
4/134 • Number of events 4
|
1.7%
3/172 • Number of events 3
|
|
Psychiatric disorders
Stress
|
0.75%
1/134 • Number of events 3
|
0.00%
0/172
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/134
|
0.58%
1/172 • Number of events 1
|
Other adverse events
| Measure |
Asenapine
n=134 participants at risk
|
Olanzapine
n=172 participants at risk
|
|---|---|---|
|
Infections and infestations
Influenza
|
5.2%
7/134 • Number of events 7
|
1.7%
3/172 • Number of events 3
|
|
Investigations
Weight increased
|
0.00%
0/134
|
6.4%
11/172 • Number of events 11
|
|
Nervous system disorders
Headache
|
5.2%
7/134 • Number of events 8
|
4.1%
7/172 • Number of events 8
|
|
Psychiatric disorders
Schizophrenia
|
5.2%
7/134 • Number of events 8
|
0.58%
1/172 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication/presentation of data may not be made without prior review and comment by the Sponsor; all reasonable comments of Sponsor will be incorporated as far as the scientific data content is not impaired. A complete copy shall be provided to the Sponsor at least 60 days prior to date of submission. Participation in the Study involves a commitment to publish data from the study in a cooperative publication prior to publication/presentation or on an individual basis.
- Publication restrictions are in place
Restriction type: OTHER