Postherpetic Neuralgia Clinical Trial
— RELIEF-PHN1Official 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)
Verified date | November 2023 |
Source | Lexicon Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Lexicon Pharmaceuticals |
United States, Czechia, Poland,
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 |
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