Diabetic Painful Neuropathy Study: A New Pain Relief Medication

  • STATUS
    Recruiting
Updated on 26 February 2021

Summary

We are currently seeking volunteers with either Type 1 or Type 2 diabetes, and who experience painful diabetic neuropathy daily. This is a study of a new investigational oral medication that may help to relieve the pain of diabetic neuropathy.

Eligible participants will be determined based on results from lab tests, pain questionnaires, and diagnostic procedures, Two out of every three of the participants will receive the study medication and one out of every three will receive a placebo. Participants take the medication or placebo twice daily.

Participants have the option to participate in 2 optional sub-studies:
  • One sub-study consists of 2 overnight sessions at our clinic, each lasting a 28-hour period. Patients check in around 6AM, and check out the next day at around 10 AM.
  • The other sub-study consists of 1 phone call interview that lasts for 60 minutes.
Participants will be compensated $1000 for the overnight portion of the sub study.

Description

Study Length: Approximately 15 weeks, with 7 clinic visits.

Optional: Overnight Sub-Study - Two overnight sessions at our clinic, each lasting a 28 hour period.

Target Age: 18+ years old.

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

Stipend: $525 for completion of the main study. $1000 for completion of the Overnight Sub-Study.

Details
Condition DIABETIC NEUROPATHY, Arthritis and Arthritic Pain, Chronic Pain
Clinical Study IdentifierTX267208
Last Modified on26 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have Diabetic Painful Neuropathy
Must have HbA1c ≤ 11
Must have a BMI ≤ 40
Must meet other eligibility criteria - please contact us for further details
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  • You can expect the study team to contact you via email or phone in the next few days.
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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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