LX9211 for Shingles (RELIEF-PHN1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Lexicon Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to week 6

Summary

This trial is testing a new medication, LX9211, to see if it can reduce pain in patients who have chronic pain after shingles. The medication likely works by reducing pain signals in the nervous system.

Eligible Conditions

Shingles

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Average Daily Pain Score (ADPS)

Secondary study objectives

Safety: number of AEs reported

≥30 percent reduction in pain intensity

≥50 percent reduction in pain intensity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LX9211Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

LX9211

2020

Completed Phase 2

~80

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