Do You Experience Painful Diabetic Neuropathy?

  • STATUS
    Recruiting
Updated on 23 November 2020
peripheral neuropathic pain
diabetic peripheral neuropathic pain

Summary

We are currently seeking volunteers who are diagnosed with Diabetic Peripheral Neuropathic Pain and who experience pain daily.  This is a study of a new investigational medication that may help to relieve the pain of Diabetic Neuropathy.

Description

Eligible participants will be determined based upon results from lab tests, pain questionnaires, and diagnostic procedures.

Two out every three of the participants will receive the study medication and one out of every three will be receive a placebo. The medication is given by an intravenous (IV) infusion every 2 weeks for a total of 4 infusions.

Participants must be willing to stop taking any other pain-relieving medications, prior to starting the study medication. They can, however, take up to 3000mg per day of rescue medication (Acetaminophen).

 

Study Length: Approximately 28 weeks, with 10 clinic visits.

Target Age: 18+ years old.

Benefits: Participants will receive at no cost: study medication, pain rescue medications, neurological exams, physical exams, lab work, and ECGs.

Stipend: $1525

Details
Condition DIABETIC NEUROPATHY, Cardiovascular Disease, Arthritis and Arthritic Pain, Chronic Pain
Clinical Study IdentifierTX246580
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be 18 years old or older
Must have Diabetic Painful Neuropathy
Must have a BMI ≤ 40
Must meet other eligibility criteria
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How to participate?

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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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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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