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Radafaxine

Phase 2

Depressive Disorder, Major | Small molecule | Psychiatry |GSK plc|Last Updated: Apr 16, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment732

FDA Designations

No designations recorded

Clinical trial landscape

Radafaxine · 3 trials · 2 indications

Phase 2 3
NCT00057213An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive DisorderDepressive Disorder, Major
COMPLETED367 Analytics
NCT00057226An 8 Week Study Of Adults Diagnosed With Major Depressive DisorderDepressive Disorder, Major
COMPLETED365 Analytics
NCT00057239An 8 Week Depression Study In Adults Diagnosed With Major Depressive DisorderMajor Depressive Disorder (MDD)
COMPLETED546 Analytics
PHASE2COMPLETED
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder
Depressive Disorder, Major
NCT00057213367
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PHASE2COMPLETED
An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder
Depressive Disorder, Major
NCT00057226365
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PHASE2COMPLETED
An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder
Major Depressive Disorder (MDD)
NCT00057239546
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Study Endpoints

Primary Endpoints

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
8 Weeks
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment
8 Weeks

Secondary Endpoints

Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study;
Change in the MADRS score at other timepoints; change in the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study
Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy and pain;incidence of adverse events over course of study.
8 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
RadafaxineDRUG -
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Diagnosis of Major Depressive Disorder (MDD) * Duration of current depressive episode 12 weeks - 24 months * Patients can read and write at a level sufficient to provide a signed consent * If female, patients must be practicing an acceptable method of birth control Exclusion ...

Countries:United States
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Frequently asked questions about Radafaxine

What is Radafaxine used for?

Radafaxine is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD), including Depressive Disorder, Major. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Radafaxine?

Radafaxine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials for the treatment of Major Depressive Disorder.

What phase is Radafaxine in?

Radafaxine is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of Major Depressive Disorder.

What clinical trials is Radafaxine in?

Radafaxine has been studied in three completed Phase 2 clinical trials: NCT00057213, NCT00057226, and NCT00057239. These trials enrolled a total of 732 adults with Major Depressive Disorder in the United States. All trials are completed.

Is Radafaxine the same as any other drug?

Radafaxine is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information. It is being developed by GSK plc for Major Depressive Disorder.