Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia

Postherpetic Neuralgia Clinical Trial

— RELIEF-PHN1  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662281
• Other study ID #: LX9211.1-202-PHN
• Secondary ID: 2020-004639-26
• Status: Completed
• Phase: Phase 2
• Start date: December 29, 2020
• Est. completion date: December 21, 2022

Study information

• Verified date: November 2023
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 21, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• Placebo
LX9211 matching-placebo, tablets will be administered orally.
• LX9211
LX9211, 200 mg, tablets will be administered orally.

Locations

Country	Name	City	State
Czechia	Lexicon Investigational Site (138)	Chocen
Czechia	Lexicon Investigational Site (140)	Pardubice
Czechia	Lexicon Investigational Site (135)	Praha
Czechia	Lexicon Investigational Site (136)	Praha
Czechia	Lexicon Investigational Site (137)	Praha
Czechia	Lexicon Investigational Site (141)	Praha
Poland	Lexicon Investigational Site (128)	Katowice
Poland	Lexicon Investigational Site (130)	Katowice
Poland	Lexicon Investigational Site (134)	Lublin
Poland	Lexicon Investigational Site (133)	Warsaw
United States	Lexicon Investigational Site	Albuquerque	New Mexico
United States	Lexicon Investigational Site	Baytown	Texas
United States	Lexicon Investigational Site	Boston	Massachusetts
United States	Lexicon Investigational Site	Brandon	Florida
United States	Lexicon Investigational Site	Canton	Michigan
United States	Lexicon Investigational Site (148)	Cary	North Carolina
United States	Lexicon Investigational Site	Flossmoor	Illinois
United States	Lexicon Investigational Site	Greenbrae	California
United States	Lexicon Investigational Site	Hazelwood	Missouri
United States	Lexicon Investigational Site	Jenkintown	Pennsylvania
United States	Lexicon Investigational Site	Kenosha	Wisconsin
United States	Lexicon Investigational Site (147)	Marietta	Georgia
United States	Lexicon Investigational Site	Miami	Florida
United States	Lexicon Investigational Site	Miami	Florida
United States	Lexicon Investigational Site (113)	Miami	Florida
United States	Lexicon Investigational Site	Ormond Beach	Florida
United States	Lexicon Investigational Site	Salt Lake City	Utah
United States	Lexicon Investigational Site	Scottsdale	Arizona
United States	Lexicon Investigational Site	Tucson	Arizona
United States	Lexicon Investigational Site	Victoria	Texas
United States	Lexicon Investigational Site	Wauconda	Illinois
United States	Lexicon Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Average Daily Pain Score (ADPS)	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])	Day 1 to Week 6
Secondary	=30 percent reduction in pain intensity	Proportion of patients with =30% reduction in pain intensity	Day 1 to Week 6
Secondary	=50 percent reduction in pain intensity	Proportion of patients with =50% reduction in pain intensity	Day 1 to Week 6
Secondary	Safety: number of AEs reported	Number of Adverse Events	Day 1 to Week 6