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LX9211 for Postherpetic Neuralgia (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
Awards & highlights
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
- Postherpetic Neuralgia
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
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
Find a Location
Who is running the clinical trial?
Lexicon PharmaceuticalsLead Sponsor
65 Previous Clinical Trials
24,331 Total Patients Enrolled
Suman Wason, MDStudy DirectorLexicon Pharmaceuticals
25 Previous Clinical Trials
16,753 Total Patients Enrolled
Suma Gopinathan, PhDStudy DirectorLexicon Pharmaceuticals
1 Previous Clinical Trials
319 Total Patients Enrolled
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