Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)

  • STATUS
    Recruiting
  • End date
    Jun 4, 2022
  • participants needed
    200
  • sponsor
    Aptinyx
Updated on 4 June 2021

Summary

To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

Description

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy.

The study will be a 13- to 16-week study, including a 1- to 4-week Screening Period, followed by a 12- week double-blind, randomized, placebo-controlled Treatment Period.

Details
Condition Diabetic Peripheral Neuropathic Pain
Treatment Placebo, NYX-2925 50 mg
Clinical Study IdentifierNCT04146896
SponsorAptinyx
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent
Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities for 4 years and reports at least moderate pain over the last week
Stable diabetic and protocol allowed medication during the study
Agrees to use highly effective birth control during the study
Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study

Exclusion Criteria

Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
Current or historical serious medical conditions
Prior participation in NYX-2925 clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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