Trial Outcomes & Findings for Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia (NCT NCT01363349)
NCT ID: NCT01363349
Last Updated: 2014-09-18
Results Overview
To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.
TERMINATED
PHASE2/PHASE3
269 participants
Baseline and 6 weeks
2014-09-18
Participant Flow
Participant milestones
| Measure |
CYP-1020
CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
|
Risperidone
2-6 mg, 6 months
Risperidone
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
136
|
|
Overall Study
Randomized
|
133
|
136
|
|
Overall Study
COMPLETED
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
67
|
70
|
Reasons for withdrawal
| Measure |
CYP-1020
CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
|
Risperidone
2-6 mg, 6 months
Risperidone
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
7
|
|
Overall Study
Lack of Efficacy
|
3
|
10
|
|
Overall Study
Non compliance/Protocol deviations
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Not reported
|
36
|
37
|
|
Overall Study
missing
|
1
|
2
|
Baseline Characteristics
Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia
Baseline characteristics by cohort
| Measure |
CYP-1020
n=133 Participants
CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
|
Risperidone
n=136 Participants
2-6 mg, 6 months
Risperidone
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
32.3 years
STANDARD_DEVIATION 7.97 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
asian
|
92 number of participants
n=5 Participants
|
94 number of participants
n=7 Participants
|
186 number of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
caucasian
|
41 number of participants
n=5 Participants
|
42 number of participants
n=7 Participants
|
83 number of participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
41 participants
n=5 Participants
|
42 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Region of Enrollment
India
|
92 participants
n=5 Participants
|
94 participants
n=7 Participants
|
186 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Analysis for MCCB Score ITT population.
To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.
Outcome measures
| Measure |
CYP-1020
n=133 Participants
CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
|
Risperidone
n=136 Participants
2-6 mg, 6 months
Risperidone
|
|---|---|---|
|
Cognition
MCCB Baseline Score
|
8.7 Scores on a scale
Standard Deviation 13.66
|
8.2 Scores on a scale
Standard Deviation 13.86
|
|
Cognition
MCCB Week 6 Score
|
13.5 Scores on a scale
Standard Deviation 12.92
|
12.5 Scores on a scale
Standard Deviation 13.68
|
SECONDARY outcome
Timeframe: 12 and 24 weeks of treatmentEvaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6, 12 and 24 weeks of treatmentEvaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment
Outcome measures
Outcome data not reported
Adverse Events
CYP-1020
Risperidone
Serious adverse events
| Measure |
CYP-1020
n=133 participants at risk
CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
|
Risperidone
n=136 participants at risk
2-6 mg, 6 months
Risperidone
|
|---|---|---|
|
Infections and infestations
pneumonia
|
0.75%
1/133 • Number of events 1
|
0.00%
0/136
|
|
Musculoskeletal and connective tissue disorders
muscle rigidity
|
0.75%
1/133 • Number of events 1
|
0.00%
0/136
|
|
Psychiatric disorders
schizophrenia
|
1.5%
2/133 • Number of events 2
|
2.2%
3/136 • Number of events 3
|
|
Psychiatric disorders
completed suicide
|
0.75%
1/133 • Number of events 1
|
0.00%
0/136
|
|
Psychiatric disorders
delerium
|
0.75%
1/133 • Number of events 1
|
0.00%
0/136
|
|
Psychiatric disorders
insomnia
|
0.00%
0/133
|
0.74%
1/136 • Number of events 1
|
|
Psychiatric disorders
persecutory delusion
|
0.75%
1/133 • Number of events 1
|
0.00%
0/136
|
|
Psychiatric disorders
sleep disorder
|
0.00%
0/133
|
0.74%
1/136 • Number of events 1
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/133
|
0.74%
1/136 • Number of events 1
|
|
Renal and urinary disorders
pollakiuria
|
0.00%
0/133
|
0.74%
1/136 • Number of events 1
|
Other adverse events
| Measure |
CYP-1020
n=133 participants at risk
CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
|
Risperidone
n=136 participants at risk
2-6 mg, 6 months
Risperidone
|
|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
6.8%
9/133 • Number of events 9
|
1.5%
2/136 • Number of events 2
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
5.3%
7/133 • Number of events 7
|
2.2%
3/136 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
MUSCLE RIGIDITY
|
24.1%
32/133 • Number of events 32
|
17.6%
24/136 • Number of events 24
|
|
Nervous system disorders
TREMOR
|
22.6%
30/133 • Number of events 30
|
20.6%
28/136 • Number of events 28
|
|
Nervous system disorders
AKATHISIA
|
13.5%
18/133 • Number of events 18
|
13.2%
18/136 • Number of events 18
|
|
Nervous system disorders
SOMNOLENCE
|
8.3%
11/133 • Number of events 11
|
8.8%
12/136 • Number of events 12
|
|
Nervous system disorders
SEDATION
|
6.0%
8/133 • Number of events 8
|
1.5%
2/136 • Number of events 2
|
|
Psychiatric disorders
INSOMNIA
|
15.0%
20/133 • Number of events 20
|
19.1%
26/136 • Number of events 26
|
|
Psychiatric disorders
RESTLESSNESS
|
8.3%
11/133 • Number of events 11
|
8.8%
12/136 • Number of events 12
|
|
Psychiatric disorders
ANXIETY
|
6.0%
8/133 • Number of events 8
|
6.6%
9/136 • Number of events 9
|
|
Gastrointestinal disorders
vomiting
|
6.0%
8/133 • Number of events 8
|
2.2%
3/136 • Number of events 3
|
|
Gastrointestinal disorders
salivary hypersecretion
|
8.3%
11/133 • Number of events 11
|
4.4%
6/136 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place