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SCA-136

Phase 2

Schizophrenia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Aug 7, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment412

FDA Designations

No designations recorded

Clinical trial landscape

SCA-136 · 4 trials · 1 indication

Phase 2 1Phase 1 3
NCT00265551Study Evaluating SCA-136 in Subjects With Acute Exacerbations of SchizophreniaSchizophrenia
COMPLETED300 Analytics
PHASE2COMPLETED
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to day 42 on the positive subscale of the SCI-PANNS
Adverse events, safety laboratory results, vital signs, and ECGs will be used to monitor subject safety.
Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
safety and tolerability

Secondary Endpoints

Change from baseline to day 42 on:
SCI-PANNS total score
negative symptom sub-scale score of SCI-PANNS
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SCA-136 (200 mg)DRUG -
SCA-136 (400 mg)DRUG -
olanzapine (15 mg)DRUG -
placeboDRUG -
SCA-136DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Clinical diagnosis of schizophrenia * Ability to remain hospitalized for at least first 4 weeks of study * Needs hospitalization due to worsening of schizophrenia Exclusion Criteria: * Type 1 or 2 diabetes * Previous use of clozapine * Serious medical illness other than schi...

Countries:United StatesJapan
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Frequently asked questions about SCA-136

What is SCA-136 used for?

SCA-136 is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug has been studied in patients with acute exacerbations of schizophrenia, as well as in healthy volunteers for safety and tolerability assessments.

Who makes SCA-136?

SCA-136 is being developed by Pfizer, Inc. (NYSE: PFE). The company has conducted clinical trials evaluating the drug in patients with schizophrenia and in healthy volunteers. As of the latest data, SCA-136 is in Phase 2 development and remains an investigational compound.

What phase is SCA-136 in?

SCA-136 is in Phase 2 clinical development for schizophrenia. It is an investigational drug and has not received regulatory approval. The clinical program includes one Phase 2 study and three Phase 1 studies, all of which have been completed. No active trials are currently listed for this compound.

What clinical trials is SCA-136 in?

SCA-136 has been studied in four completed clinical trials. The Phase 2 trial (NCT00265551) evaluated the drug in 300 patients with acute exacerbations of schizophrenia. Three Phase 1 trials (NCT00447941, NCT00458107, NCT00505973) assessed safety, pharmacokinetics, and tolerability in healthy volunteers, including Japanese and non-Japanese subjects.

Is SCA-136 the same as any other drug?

SCA-136 is a unique investigational compound developed by Pfizer. No alternative names have been reported for this drug. It is a small molecule being studied specifically for schizophrenia and is not known to be identical to any other marketed or investigational medication.