Efficacy and Safety of LX9211 in Patients With Postherpetic Neuralgia

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals

Criteria

Inclusion Criteria:

• Patient has given written informed consent to participate in the study in accordance with local regulations

• Adult male and female patients ≥18 years of age at the time of screening

• PHN pain that is present for ≥3 months after healing of herpes zoster skin rash affecting a single dermatome (Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous)

• Moderate to severe pain as confirmed by average pain score using scores recorded in the pain diary in the 14 days prior to randomization

Exclusion Criteria:

• Presence of other painful conditions that may confound assessment or self-evaluation of PHN

• History of major depressive episode, active, significant psychiatric disorders

• History of clinically significant drug or alcohol use disorder

• PHN affecting the face

• Use of opioid medications for management of PHN within the 2 months prior to Screening Visit

• Use of NSAIDs for the specific treatment of PHN pain