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Clinical Trial Designed to Determine the Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy

NCT02435199 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-08-26

No results posted yet for this study

Summary

The study consists of two periods, the Screening Period (\~3 weeks) and Treatment Period (12 weeks).

Eligibility for the study will be determined by Screening tests, physical examination/medical history, and fulfilment of eligibility criteria including assessment of pain completed during the Screening Period. Potential participants will be required to provide written informed consent prior to any study-specific Screening procedures being performed.

Following Screening assessments, patients will be randomized to receive either EMA401 300 mg BID or placebo.

Patient study visits during the Treatment Period are at the end of baseline/randomization visit, and end of Weeks 3, 6, 9, and 12, for assessments.

Conditions

  • Diabetic Neuropathies

Interventions

DRUG

EMA401 600mg

DRUG

Placebo

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Spinifex Pharmaceuticals Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-10-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02435199 on ClinicalTrials.gov