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DIVALPROATE

Phase 3

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

DIVALPROATE target and mechanism

ModalitySmall molecule

Also known as SODIUM DIVALPROATE

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

DIVALPROATE clinical trials

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?

Divalproate is being studied for the treatment of bipolar disorder. It is a small molecule therapy in Phase 3 clinical development. The clinical program has focused on evaluating its use in adolescents with bipolar disorder, with a completed Phase 3 safety study conducted in France.

Who makes divalproate?

Divalproate is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for the clinical development of divalproate in bipolar disorder.

What phase is divalproate in?

Divalproate is in Phase 3 clinical development for bipolar disorder. It is an investigational therapy and has not been approved by the FDA for this indication based on the available information. The Phase 3 program includes one completed trial.

What clinical trials is divalproate in?

Divalproate has been evaluated in one Phase 3 clinical trial, NCT00271258, titled Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents. The trial was completed, enrolled 200 participants, and was conducted in France. It was an uncontrolled study without randomization or double blinding.

Is divalproate the same as sodium divalproate?

Yes, divalproate is also known as sodium divalproate. The two names refer to the same small molecule therapeutic being developed by Sanofi for bipolar disorder. Searches for either name refer to the same investigational asset.