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TAK-583

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment338

FDA Designations

No designations recorded

Clinical trial landscape

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, Postherpetic
NCT00377598399
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PHASE2COMPLETED
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
Diabetic Neuropathies
NCT00760955338
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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 neuropathic pain conditions, specifically postherpetic neuralgia and diabetic peripheral neuropathy. It is being developed by Takeda Pharmaceutical Company Limited (Takeda) and is currently in Phase 2 clinical development.

What does TAK-583 target?

TAK-583 is a small molecule being developed by Takeda for neuropathic pain. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied in conditions such as postherpetic neuralgia and diabetic peripheral neuropathy.

Who makes TAK-583?

TAK-583 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is conducting clinical trials to evaluate the efficacy and safety of TAK-583 in patients with neuropathic pain conditions.

What phase is TAK-583 in?

TAK-583 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in postherpetic neuralgia and one in diabetic peripheral neuropathy. The drug is not approved and remains investigational.

What clinical trials is TAK-583 in?

TAK-583 has completed two Phase 2 trials. NCT00377598 studied TAK-583 in 399 subjects with postherpetic neuralgia across multiple countries. NCT00760955 studied TAK-583 in 338 subjects with diabetic peripheral neuropathy in the United States and Canada. Both trials were randomized, double-blind, and placebo-controlled.

Is TAK-583 the same as another drug?

TAK-583 is the primary name used in clinical trials for this investigational compound. No alternative names have been reported in the available clinical trial information. It is being developed by Takeda for neuropathic pain conditions.