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DIVALPROATE

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: Jan 11, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

DIVALPROATE · 1 trial · 1 indication

Phase 3 1
NCT00271258Safety Study of Sodium Divalproate in Bipolar Disorder in AdolescentsBipolar Disorder
COMPLETED200 Analytics
PHASE3COMPLETED
Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

clinical examination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
SODIUM DIVALPROATEDRUG -
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Eligibility Criteria

Age Range13 Years to 18 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adolescent boys or girls aged 13 to 18 inclusive * Weighing more than 40 kg * Capable of understanding the protocol * Who have given their written consent, as have their parents or legal guardian unless the adolescent has passed his/her 18th birthday * Presenting the diagnosti...

Countries:France
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Frequently asked questions about DIVALPROATE

What is Divalproate used for in Bipolar Disorder?

Divalproate is a small molecule being developed for the treatment of Bipolar Disorder. It is currently in Phase 3 clinical development, though the specific trial has been completed. The drug is intended for use in this psychiatric condition, and it is being studied in adolescent patients.

Who makes Divalproate?

Divalproate is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. Sanofi is the developer of this small molecule drug, which is intended for the treatment of Bipolar Disorder. The drug is currently in Phase 3 clinical development.

What phase is Divalproate in?

Divalproate is in Phase 3 clinical development. The Phase 3 trial, identified as NCT00271258, has been completed. This trial was a safety study of sodium divalproate in adolescents with Bipolar Disorder, and it enrolled 200 participants in France.

What clinical trials is Divalproate in?

Divalproate has one completed Phase 3 clinical trial, NCT00271258, titled 'Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents.' This trial enrolled 200 participants aged 13 years and older in France. The study was not randomized, double-blind, or controlled, and it did not use a biomarker.

Is Divalproate FDA approved?

Divalproate is an investigational drug and is not FDA approved. It is currently in Phase 3 clinical development for Bipolar Disorder, with its Phase 3 trial completed. The drug has not yet received regulatory approval, and its safety and efficacy are still being evaluated.