Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia (RELIEF-PHN1)

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Postherpetic Neuralgia

Treatments: Drug: Placebo; Drug: LX9211

Study type: Interventional

Funder types: Industry

Identifiers

NCT04662281

2020-004639-26 (EudraCT Number)

LX9211.1-202-PHN

Details and patient eligibility

About

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

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Following a 2-week Single-blind Run-in period, participants will receive a single loading dose of matching-placebo to LX9211 tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6.

Treatment:

Drug: Placebo

LX9211

Experimental group

Description:

Following a 2-week Single-blind Run-in period, participants will receive a single loading dose of 200 milligrams (mg) tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6.

Treatment:

Drug: LX9211