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Amisulpride

Phase 2

Bipolar Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: Apr 10, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Amisulpride · 1 trial · 1 indication

Phase 2 1
NCT00126009SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I PatientsBipolar Disorder
COMPLETED120 Analytics
PHASE2COMPLETED
SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Combination of the percentage of responders defined by a decrease of at least 50% of the Y-MRS (Young Mania Rating Scale) between D0 and D END and the completion of the 3-month treatment period.

Secondary Endpoints

Other efficacy criteria (such as the changes in Y-MRS scores between D0 and D 21, between D0 and D END.The percentage of remission defined as the Y-MRS < or = 12 at D END...). Safety data (clinical, ECG and laboratory data)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AmisulprideDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Pre-Inclusion Criteria on D-3: * In-patients * From 18 to 65 years old * Able to comply with the protocol * Having given their written informed consent (with a legal representative or a person of trust) * Current diagnosis of bipolar I disorder according to DSM IV TR (APA 2000)...

Countries:CzechiaFrancePolandSlovakiaSpain
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Frequently asked questions about Amisulpride

What is Amisulpride used for in Bipolar Disorder?

Amisulpride is an investigational small molecule being studied for the treatment of Bipolar Disorder. It is currently in Phase 2 clinical development. The drug is being evaluated in patients with bipolar I disorder, specifically in combination with valproate, as part of a clinical trial.

Who makes Amisulpride?

Amisulpride is being developed by Sanofi, a multinational pharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical research to evaluate the safety and efficacy of Amisulpride for the treatment of Bipolar Disorder.

What phase is Amisulpride in?

Amisulpride is currently in Phase 2 clinical development for Bipolar Disorder. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a clinical trial to assess its potential as a treatment for this condition.

What clinical trials is Amisulpride in?

Amisulpride has been studied in a Phase 2 clinical trial with the identifier NCT00126009, titled 'SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients'. This trial has been completed and enrolled 120 participants across multiple countries, including Czechia, France, Poland, Slovakia, and Spain.

Is Amisulpride the same as any other drug?

Amisulpride is a distinct drug entity and is not known to be the same as any other drug under a different name. It is being investigated as a potential treatment for Bipolar Disorder, and its development is being conducted by Sanofi.