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TAK-583

Phase 2

Diabetic Neuropathies | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Trials Updated: Jun 22, 2016

TAK-583 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Sep 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment737

FDA Designations

No designations recorded

TAK-583 clinical trials

TAK-583 · 2 trials · 2 indications

Phase 2 2
NCT00377598Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic NeuralgiaNeuralgia, Postherpetic
COMPLETED399 Analytics
NCT00760955Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral NeuropathyDiabetic Neuropathies
COMPLETED338 Analytics
PHASE2COMPLETED
Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia
Neuralgia, PostherpeticUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
Diabetic NeuropathiesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in average daily pain intensity score for the previous 7 days
Week 8 or Final Visit
Change from Baseline for a composite measure of Maximal Nerve Conduction Velocity of the Peroneal and Median Motor Nerves and the Median and Sural Sensory Nerves.
Month 6 or Final Visit

Secondary Endpoints

Change from baseline to each study visit in average daily pain intensity score for the last 7 days
At All Visits
Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire
Week 8 or Final Visit
Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary)
Week 8 or Final Visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAK-583 5 mg QDEXPERIMENTAL -
TAK-583 25 mg QDEXPERIMENTAL -
TAK-583 50 mg QDEXPERIMENTAL -
TAK-583 100 mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
TAK-583DRUGTAK-583 5 mg, tablets, orally, once daily for up to 8 weeks
PlaceboDRUGTAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Male and female subjects with postherpetic neuralgia whose pain has been present for \>3 months following healing of the herpes zoster rash. * Subjects with an mean pain intensity score of 4 or more (determined from at least 4 daily recordings of pain intensity on an 11-point ...

Countries:AustraliaBulgariaCzechiaGermanyNetherlandsPolandRussiaSouth AfricaUnited KingdomUnited StatesCanada
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Frequently asked questions about TAK-583

What is TAK-583 used for?

TAK-583 is an investigational small molecule being studied for the treatment of diabetic neuropathies and postherpetic neuralgia, which are types of nerve pain. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes TAK-583?

TAK-583 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda's stock is listed on the New York Stock Exchange under the ticker symbol TAK.

What phase is TAK-583 in?

TAK-583 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Two Phase 2 trials have been completed, but the drug is not currently in active clinical trials.

What clinical trials has TAK-583 been in?

TAK-583 has been studied in two completed Phase 2 trials. NCT00377598 evaluated the drug in 399 subjects with postherpetic neuralgia across multiple countries. NCT00760955 assessed its efficacy and safety in 338 subjects with diabetic peripheral neuropathy in the United States and Canada.

How does TAK-583 work?

TAK-583 is a small molecule being investigated for its potential to treat nerve pain conditions. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not publicly detailed.

Is TAK-583 the same as any other drug?

No alternative names for TAK-583 have been disclosed. It is identified solely by its investigational code name TAK-583 in clinical trial registries and available data.