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vabicaserin

Phase 2

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Mar 20, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment199

FDA Designations

No designations recorded

Clinical trial landscape

vabicaserin · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT00563706Study Evaluating Vabicaserin in Subjects With SchizophreniaSchizophrenia
COMPLETED199 Analytics
PHASE2COMPLETED
Study Evaluating Vabicaserin in Subjects With Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
Baseline

PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
Baseline, Day 28

PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC.
2 months
Assess the bioavailability of four oral formulations of vabicaserin.

Secondary Endpoints

Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
Baseline, Day 7, 14, 21, 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR4mg/day
3PLACEBO_COMPARATORmatching placebo

Interventions

NameTypeDescription
vabicaserinDRUGThis study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
risperidoneDRUG -
placeboOTHER -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Generally healthy, men and women, aged 18 to 65. * Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year. * Ability to remain hospitalized for the duration of the screening period and for 4 weeks of ...

Countries:United StatesCanada
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Frequently asked questions about vabicaserin

What is vabicaserin?

Vabicaserin is an investigational small molecule being developed by Pfizer, Inc. (NYSE: PFE). It has been studied in schizophrenia and in healthy subjects. Vabicaserin is in clinical development, with completed trials in Phase 1 and Phase 2.

What is vabicaserin used for?

Vabicaserin has been studied for use in schizophrenia, as well as in healthy subjects for bioavailability and formulation studies. It is an investigational drug and has not been approved by the FDA.

Who makes vabicaserin?

Vabicaserin is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker PFE.

What phase is vabicaserin in?

Vabicaserin has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it is still in clinical development and has not been approved for any use.

What clinical trials has vabicaserin been in?

Vabicaserin has been studied in clinical trials including NCT00541996, a Phase 1 study comparing bioavailability of oral formulations in schizophrenia patients; NCT00563706, a Phase 2 study in subjects with schizophrenia; and NCT00928551, a Phase 1 comparative formulation study in healthy subjects.

Is vabicaserin the same as any other drug?

Vabicaserin is not known by any other names. It is a distinct investigational compound developed by Pfizer.