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SCA-136

Phase 2

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

SCA-136 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Jan 2007

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

SCA-136 clinical trials

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?

SCA-136 is an investigational small molecule being developed by Pfizer, Inc. (ticker PFE) for the treatment of schizophrenia, a psychiatric disorder. It has been studied in Phase 1 and Phase 2 clinical trials, and it is also referred to as SCA-136 (200 mg).

What is SCA-136 used for in schizophrenia?

SCA-136 is being evaluated as a treatment for schizophrenia, including acute exacerbations of the condition. It is an investigational therapy and has not been approved for commercial use. Clinical studies have enrolled both healthy volunteers and patients with schizophrenia.

Who makes SCA-136?

Pfizer, Inc., which trades under the ticker PFE, is the developer of SCA-136. The company has sponsored four completed clinical trials of the drug, including Phase 1 studies in healthy Japanese and non-Japanese subjects and a Phase 2 study in patients with schizophrenia.

What phase is SCA-136 in?

SCA-136 has completed Phase 2 clinical development. Four trials have been completed in total, three Phase 1 studies and one Phase 2 study, and no trials are currently active. The drug remains investigational and is not approved for marketing.

What clinical trials is SCA-136 in?

SCA-136 has been studied in four completed trials: NCT00505973 and NCT00447941 in healthy Japanese male subjects, NCT00458107 in healthy Japanese and non-Japanese female subjects, and NCT00265551, a Phase 2 study in subjects with acute exacerbations of schizophrenia. Total enrollment across these trials was 412 participants.