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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

RELIEF-PHN1 Trial Summary

This trial looks at whether LX9211 can reduce pain related to postherpetic neuralgia better than a placebo.

Eligible Conditions

Postherpetic Neuralgia

RELIEF-PHN1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Average Daily Pain Score (ADPS)

Secondary outcome measures

Safety: number of AEs reported

≥30 percent reduction in pain intensity

≥50 percent reduction in pain intensity

RELIEF-PHN1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lexicon PharmaceuticalsLead Sponsor

63 Previous Clinical Trials

23,511 Total Patients Enrolled

Suman Wason, MDStudy DirectorLexicon Pharmaceuticals

25 Previous Clinical Trials

16,879 Total Patients Enrolled

Suma Gopinathan, PhDStudy DirectorLexicon Pharmaceuticals

1 Previous Clinical Trials

319 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently a recruitment period for this research project?

"Clinicaltrials.gov indicates that this trial is no longer actively recruiting, as the original posting date was December 29th 2020 and it most recently updated on November 18th 2022. However, there are still 160 other medical studies currently looking for participants."

Answered by AI

How many American sites are presently conducting this research?

"Currently, this scientific trial is looking for 21 participants from various locations including Brandon, Flossmoor and Salt Lake City. To reduce the strain of commuting to appointment it may be beneficial to find a clinic close by."

Answered by AI