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RELIEF-PHN1: Efficacy and Safety of LX9211 in Patients With Postherpetic Neuralgia

Sponsor
Lexicon Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04662281
Collaborator
(none)
74
Enrollment
32
Locations
2
Arms
24
Anticipated Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX9211 in the Treatment of Postherpetic Neuralgia (RELIEF-PHN1)
Actual Study Start Date :
Dec 29, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: LX9211

LX9211, once daily

Drug: LX9211
11-week assessment period
Placebo Comparator: Placebo

Placebo, once daily

Drug: Placebo
11-week assessment period

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Average Daily Pain Score (ADPS) [Day 1 to Week 6]

    The change from Baseline (Week 2) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (0 [No Pain] to 10 [Pain as bad as you can imagine])

Secondary Outcome Measures

  1. ≥30 percent reduction in pain intensity [Day 1 to Week 6]

    Proportion of patients with ≥30% reduction in pain intensity

  2. ≥50 percent reduction in pain intensity [Day 1 to Week 6]

    Proportion of patients with ≥50% reduction in pain intensity

  3. Safety: number of AEs reported [Day 1 to Week 6]

    Number of Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patient has given written informed consent to participate in the study in accordance with local regulations

  • Adult male and female patients ≥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 (Patients 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 NSAIDs for the specific treatment of PHN pain

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lexicon Investigational Site Scottsdale Arizona United States 85258
2 Lexicon Investigational Site Tucson Arizona United States 85741
3 Lexicon Investigational Site Greenbrae California United States 94904
4 Lexicon Investigational Site Brandon Florida United States 33511
5 Lexicon Investigational Site (113) Miami Florida United States 33032
6 Lexicon Investigational Site Miami Florida United States 33144
7 Lexicon Investigational Site Miami Florida United States 33174
8 Lexicon Investigational Site Ormond Beach Florida United States 32174
9 Lexicon Investigational Site Winter Park Florida United States 32789
10 Lexicon Investigational Site (147) Marietta Georgia United States 30060
11 Lexicon Investigational Site Flossmoor Illinois United States 60422
12 Lexicon Investigational Site Wauconda Illinois United States 60084
13 Lexicon Investigational Site Boston Massachusetts United States 02131
14 Lexicon Investigational Site Canton Michigan United States 48187
15 Lexicon Investigational Site Hazelwood Missouri United States 63042
16 Lexicon Investigational Site Albuquerque New Mexico United States 87102
17 Lexicon Investigational Site (148) Cary North Carolina United States 27518
18 Lexicon Investigational Site Jenkintown Pennsylvania United States 19046
19 Lexicon Investigational Site Baytown Texas United States 77521
20 Lexicon Investigational Site Victoria Texas United States 77901
21 Lexicon Investigational Site Salt Lake City Utah United States 84102
22 Lexicon Investigational Site Kenosha Wisconsin United States 53144
23 Lexicon Investigational Site (138) Choceň Czechia 565 01
24 Lexicon Investigational Site (140) Pardubice Czechia 53002
25 Lexicon Investigational Site (136) Praha Czechia 100 00 00
26 Lexicon Investigational Site (137) Praha Czechia 12000
27 Lexicon Investigational Site (141) Praha Czechia 13000
28 Lexicon Investigational Site (135) Praha Czechia 16000
29 Lexicon Investigational Site (128) Katowice Poland 40-282
30 Lexicon Investigational Site (130) Katowice Poland 640-748
31 Lexicon Investigational Site (134) Lublin Poland 20-064
32 Lexicon Investigational Site (133) Warsaw Poland 01-868

Sponsors and Collaborators

  • Lexicon Pharmaceuticals

Investigators

  • Study Director: Suman Wason, MD, Lexicon Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04662281
Other Study ID Numbers:
  • LX9211.1-202-PHN
First Posted:
Dec 10, 2020
Last Update Posted:
Aug 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic

Study Results

No Results Posted as of Aug 15, 2022