Status:
COMPLETED
Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Postherpetic Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.
Eligibility Criteria
Inclusion
- Participant has given written informed consent to participate in the study in accordance with local regulations
- Adult male and female participants ≥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 (Participants 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
- 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 Non-steroidal anti-inflammatory drugs (NSAIDs) for the specific treatment of PHN pain
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04662281
Start Date
December 29 2020
End Date
December 21 2022
Last Update
November 18 2023
Active Locations (32)
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1
Lexicon Investigational Site
Scottsdale, Arizona, United States, 85258
2
Lexicon Investigational Site
Tucson, Arizona, United States, 85741
3
Lexicon Investigational Site
Greenbrae, California, United States, 94904
4
Lexicon Investigational Site
Brandon, Florida, United States, 33511