Overview

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