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PF-00217830

Phase 2

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Apr 18, 2012

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment164
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00580125Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of SchizophreniaPHASE2 COMPLETED 164 — — Nov 1, 2007Sep 1, 2008Apr 18, 201226 United States, India +2
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Study Endpoints
Primary Endpoints
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
5 weeks
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
Screening, Day 1, 3, 7, 14 and 21
Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),
5 weeks
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
4 weeks
Secondary Endpoints
PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Screening, Day 1, 3, 7, 14 and 21
PANSS positive, negative, and general psychopathology subscales
Screening, Day 1, 3, 7, 14 and 21
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Screening and Days 1, 3, 7, 14 and 21
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A2EXPERIMENTAL -
A5PLACEBO_COMPARATOR -
A4ACTIVE_COMPARATOR -
A3EXPERIMENTAL -
A1EXPERIMENTAL -
Interventions
NameTypeDescription
PF-00217830DRUGPF-00217830 5 mg, oral capsule, once daily for 21 days
PlaceboOTHERPlacebo, oral capsule, once daily for 21 days
AripiprazoleDRUGAripiprazole 15 mg, oral capsule, once daily for 21 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: Key inclusion criteria include: * Have a current diagnosis of schizophrenia. * Increase in symptoms over the past 2-4 weeks. * Willing to remain inpatients for the duration of the trial. Exclusion Criteria: * Subjects with a current DSM-IV axis I diagnosis other than schizoph...

Countries:United StatesIndiaRussiaUkraine
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Competitive Landscape -Schizophrenia 38 trials
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Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
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Novartis AG Sponsored ADRNVS1PHASE2GXV813
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Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Unity Health TorontoUBX1NAUndisclosed
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