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Radafaxine

Phase 2

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

Radafaxine development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Mar 2003

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment1,278

FDA Designations

No designations recorded

Radafaxine clinical trials

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, MajorUnlock trial analytics
PHASE2COMPLETED
An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder
Depressive Disorder, MajorUnlock trial analytics
PHASE2COMPLETED
An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder
Major Depressive Disorder (MDD)Unlock trial analytics

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 was studied for the treatment of major depressive disorder, a form of depressive disorder. It is a small molecule therapeutic candidate developed by GSK plc. All three of its clinical trials enrolled adults aged 18 years and older who were diagnosed with major depressive disorder.

Who is developing Radafaxine?

Radafaxine is developed by GSK plc, which trades under the ticker GSK. The company sponsored all three of the Phase 2 clinical trials of radafaxine in major depressive disorder, which together enrolled 1,278 participants across sites in the United States.

What phase is Radafaxine in?

Radafaxine is in Phase 2 clinical development. All three of its trials were Phase 2 studies in major depressive disorder, and all three are now completed. There are no active trials of radafaxine currently listed, so it remains an investigational drug rather than an approved therapy.

What clinical trials is Radafaxine in?

Radafaxine has been evaluated in three completed Phase 2 trials: NCT00057239, which enrolled 546 adults; NCT00057226, which enrolled 365 adults; and NCT00057213, which enrolled 367 adults. Each was an 8 week study of adults diagnosed with major depressive disorder conducted in the United States.

How were the Radafaxine trials designed?

The radafaxine Phase 2 program consisted of three completed 8 week trials in adults with major depressive disorder. The studies were randomized and double blind, and enrolled a combined total of 1,278 participants aged 18 years and older. Participants were not selected based on a biomarker.