Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia (NCT04662281) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
United States79 participantsStarted 2020-12-10
Plain-language summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Postherpetic neuralgia (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 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 Non-steroidal anti-inflammatory drugs (NSAIDs) for the specific treatment of PHN pain
What they're measuring
1
Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS)
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6