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JNJ-37822681

Phase 2

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Mar 26, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment531
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00728195An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With SchizophreniaPHASE2 COMPLETED 498Nov 1, 2008Feb 1, 2010Mar 26, 201445 Bulgaria, Estonia +8
NCT01812642A Pharmacokinetics Study to Evaluate Safety and Tolerability of JNJ-37822681 in Participants With Stable SchizophreniaPHASE2 COMPLETED 33Jul 1, 2008Dec 1, 2008Mar 18, 20146 Belgium, Germany +3
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Study Endpoints
Primary Endpoints
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Baseline and Week 6

The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Day 14
Baseline and Day 14

The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7.

Barnes Akathisia Rating Scale (BARS) Score
Day 14

The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: range 0 to 3), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia.

Change From Baseline in Simpson Angus Rating Scale (SAS) Score
Baseline and Day 14

The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.

Secondary Endpoints
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 6 and 12
Baseline, Week 6 and 12
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 6 and 12
Baseline, Week 6 and 12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 6 and 12
Baseline, Week 6 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo First, Then OlanzapinePLACEBO_COMPARATORParticipants will receive 2 matching placebo capsules orally twice daily for 6 consecutive weeks, then 2 matching placebo capsules orally in the morning and olanzapine 10 milligram (mg) capsule along with matching placebo capsule orally in the evening for next 1 week, then 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with olanzapine 5 mg capsule orally in the evening for next 5 weeks.
JNJ-37822681 10 mgEXPERIMENTALParticipants will receive 1 matching placebo capsule along with JNJ-37822681 10 mg capsule orally twice a day for 12 consecutive weeks.
JNJ-37822681 20 mgEXPERIMENTALParticipants will receive 1 matching placebo capsule along with JNJ-37822681 20 mg capsule orally twice a day for 12 consecutive weeks.
JNJ-37822681 30 mgEXPERIMENTALParticipants will receive JNJ-37822681 30 mg (one 10 mg capsule along with JNJ-37822681 20 mg capsule) orally twice a day for 12 consecutive weeks.
OlanzapineACTIVE_COMPARATORParticipants will receive 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with matching placebo capsule orally in the evening for 1 week, then 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with olanzapine 5 mg capsule orally in the evening for next 11 consecutive weeks.
JNJ-37822681 10 milligramEXPERIMENTALJNJ-37822681 oral capsule will be administered at a starting dose of 10 milligram (mg) twice daily for the first 3 days and thereafter dose will be titrated from Day 3 to Day 10 up to 80 mg per day and will be continued at same dose up to Day 14.
JNJ-37822681 20 milligram and placeboEXPERIMENTALJNJ-37822681 oral capsule will be administered at a starting dose of 20 mg once daily for the first 3 days and thereafter dose will be titrated from Day 3 to Day 10 up to 80 mg per day and will be continued at same dose up to Day 14. Matching Placebo will be administered orally in the evening for 14 days (12 hour post JNJ-37822681 administration).
Interventions
NameTypeDescription
JNJ-37822681DRUGParticipants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks.
OlanzapineDRUGParticipants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks.
PlaceboDRUGParticipants will receive matching placebo capsules orally for 12 weeks.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: * Participants must have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening * Participants must be experiencing an acute (a quick a...

Countries:BulgariaEstoniaLithuaniaMalaysiaRomaniaRussiaSouth AfricaSouth KoreaTaiwanUkraineBelgiumGermanySlovakiaSweden
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