Trial Outcomes & Findings for 6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772) (NCT NCT00174265)

Results Overview

The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

196 participants

Primary outcome timeframe

Baseline of A7501013 to Day 365

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Asenapine 5-10 mg sublingually twice daily for 26 weeks	Olanzapine 5-20 mg by mouth once daily for 26 weeks
Overall Study STARTED	86	110
Overall Study COMPLETED	57	89
Overall Study NOT COMPLETED	29	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Asenapine 5-10 mg sublingually twice daily for 26 weeks	Olanzapine 5-20 mg by mouth once daily for 26 weeks
Overall Study Adverse Event	7	4
Overall Study Lack of Efficacy	2	2
Overall Study Withdrawal by Subject	3	5
Overall Study Lost to Follow-up	1	0
Overall Study Other (Not specified)	16	10

Baseline Characteristics

6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asenapine n=85 Participants 5-10 mg sublingually twice daily for 26 weeks	Olanzapine n=110 Participants 5-20 mg by mouth once daily for 26 weeks	Total n=195 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=93 Participants	108 Participants n=4 Participants	192 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	27 Participants n=4 Participants	45 Participants n=27 Participants
Sex: Female, Male Male	67 Participants n=93 Participants	83 Participants n=4 Participants	150 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline of A7501013 to Day 365

Population: Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model.

The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	Asenapine n=83 Participants 5-10 mg sublingually twice daily for 26 weeks	Olanzapine n=110 Participants 5-20 mg by mouth once daily for 26 weeks
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score Baseline	61.5 Units on a Scale Standard Error 1.37	60.3 Units on a Scale Standard Error 1.20
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score Change from Baseline at Day 365	-15.8 Units on a Scale Standard Error 1.48	-11.0 Units on a Scale Standard Error 1.27

SECONDARY outcome

Timeframe: Baseline of A7501013 to Day 365

Population: ITT population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the MMRM model.

The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.

Outcome measures

Outcome measures
Measure	Asenapine n=83 Participants 5-10 mg sublingually twice daily for 26 weeks	Olanzapine n=110 Participants 5-20 mg by mouth once daily for 26 weeks
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score Change from Baseline at Day 365	12.4 Units on a Scale Standard Error 2.05	11.7 Units on a Scale Standard Error 1.73
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score Baseline	45.3 Units on a Scale Standard Error 2.27	42.3 Units on a Scale Standard Error 1.99

Adverse Events

Asenapine

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Olanzapine

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Asenapine n=85 participants at risk 5-10 mg sublingually twice daily for 26 weeks	Olanzapine n=110 participants at risk 5-20 mg by mouth once daily for 26 weeks
Gastrointestinal disorders Gastritis	0.00% 0/85	0.91% 1/110 • Number of events 1
Metabolism and nutrition disorders Hyponatraemia	1.2% 1/85 • Number of events 1	0.00% 0/110
Psychiatric disorders Alcohol Abuse	1.2% 1/85 • Number of events 1	0.00% 0/110
Psychiatric disorders Psychotic Disorder	1.2% 1/85 • Number of events 1	0.00% 0/110
Psychiatric disorders Schizophrenia	0.00% 0/85	2.7% 3/110 • Number of events 3
Psychiatric disorders Schizophrenia, Paranoid Type	1.2% 1/85 • Number of events 1	0.00% 0/110

Other adverse events

Other adverse events
Measure	Asenapine n=85 participants at risk 5-10 mg sublingually twice daily for 26 weeks	Olanzapine n=110 participants at risk 5-20 mg by mouth once daily for 26 weeks
Infections and infestations Nasopharyngitis	2.4% 2/85 • Number of events 2	7.3% 8/110 • Number of events 10
Investigations Weight Increased	5.9% 5/85 • Number of events 5	11.8% 13/110 • Number of events 13
Nervous system disorders Headache	2.4% 2/85 • Number of events 2	7.3% 8/110 • Number of events 12
Psychiatric disorders Insomnia	10.6% 9/85 • Number of events 9	5.5% 6/110 • Number of events 7

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Except for compelling legal reasons, neither the sponsor nor the investigator will communicate to third parties any result of the clinical trial before the clinical trial report has been released by the sponsor.
Publication restrictions are in place

Restriction type: OTHER