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Experimental

Phase 2

Diabetic Neuropathy | Small molecule | Neurology |Roche Holding AG|Last Updated: Nov 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment159

FDA Designations

No designations recorded

Clinical trial landscape

Experimental · 1 trial · 1 indication

Phase 2 1
NCT00496457Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic NeuropathyDiabetic Neuropathy
COMPLETED159 Analytics
PHASE2COMPLETED
Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy
Diabetic NeuropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Effect of TRO19622 versus Placebo on the mean 24h neuropathic pain score on the Likert numerical rating scale.
During the last 7 days of the 6-week treatment period

Secondary Endpoints

24h Pain time course
Duration of study (within 11weeks after screening)
Analysis for treatment effects: SF-MPQ, SF-BPI, SF36, POMS, Global Impression of Change (Patient / Investigator)
Within 6 weeks of treatment
Adverse events
During the course of the study.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTRO19622
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ExperimentalDRUGCapsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks
Placebo comparatorDRUG4 Capsules of PBO per day before noon meal
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Be a male \>18 years or a post-menopausal female (\>60 years of age and at least 1 year of amenorrhea). * Have painful diabetic neuropathy of \>6 months duration and are either pain treatment naive or have important side effects or inadequate relief from their current pain med...

Countries:CroatiaGermanyLatviaPolandSerbia
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Frequently asked questions about Experimental

What is Experimental used for in Diabetic Neuropathy?

Experimental is an investigational small molecule being studied for the treatment of painful peripheral diabetic neuropathy. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its potential to address this neurological condition associated with diabetes.

Who makes Experimental?

Experimental is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded over-the-counter under the ticker symbol RHHBY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for diabetic neuropathy.

What phase is Experimental in?

Experimental is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug remains investigational and has not received approval from regulatory agencies. Further clinical studies may be needed to establish its safety and effectiveness.

What clinical trials is Experimental in?

Experimental has been studied in one completed Phase 2 clinical trial, registered as NCT00496457. This study evaluated the efficacy of a 500 mg daily dose of the drug compared to placebo in patients with painful peripheral diabetic neuropathy. The trial enrolled 159 participants across Croatia, Germany, Latvia, Poland, and Serbia.

Is Experimental the same as TRO19622?

Yes, Experimental is also known as TRO19622. The completed Phase 2 clinical trial NCT00496457 used the name TRO19622 to refer to the drug. This alternative name may appear in scientific literature and clinical trial registries, while Experimental is used as the development name.