Study evaluating the efficacy, safety, and pharmacokinetics of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1)

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Study evaluating the efficacy, safety, and pharmacokinetics of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1)

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clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Male or Female ≥ 18 years of age
  2. History of T1DM or T2DM with chronic diabetic peripheral neuropathy (≥ 6 months)
  3. Moderate to severe pain secondary to diabetic peripheral neuropathy
  4. A1c ≤ 11 %
Exclusion Criteria
  1. Use of opioids
  2. Use of chronic NSAIDs
  3. CrCl < 60 mL/min
  4. History of neurolytic or neurosurgical therapy for diabetic peripheral neuropathy
  5. History of seizure disorder requiring treatment with antiepileptic medications
  6. History of Major Depressive Episode within the past year (DSM-5 criteria)
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