AzTrials
AzTrials

Postherpetic NeuralgiaPhase 2RELIEF-PHN1NCT04662281

Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia

A Phase 2 study testing LX9211 in people with Postherpetic Neuralgia, run by Lexicon Pharmaceuticals at 32 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Postherpetic Neuralgia
What is being tested?
LX9211
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
32 sitesin 3 countries
Study dates
10 Dec 2020to 28 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Postherpetic neuralgia (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

Who cannot join

  • 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

Trial locations and contacts

32 sites in 3 countries.

32 sites in 3 countries

United States22 sites

  • Lexicon Investigational Site

    Albuquerque, New Mexico, 87102

  • Lexicon Investigational Site

    Baytown, Texas, 77521

  • Lexicon Investigational Site

    Boston, Massachusetts, 02131

  • Lexicon Investigational Site

    Brandon, Florida, 33511

  • Lexicon Investigational Site

    Canton, Michigan, 48187

  • Lexicon Investigational Site (148)

    Cary, North Carolina, 27518

  • Lexicon Investigational Site

    Flossmoor, Illinois, 60422

  • Lexicon Investigational Site

    Greenbrae, California, 94904

  • Lexicon Investigational Site

    Hazelwood, Missouri, 63042

  • Lexicon Investigational Site

    Jenkintown, Pennsylvania, 19046

  • Lexicon Investigational Site

    Kenosha, Wisconsin, 53144

  • Lexicon Investigational Site (147)

    Marietta, Georgia, 30060

  • Lexicon Investigational Site (113)

    Miami, Florida, 33032

  • Lexicon Investigational Site

    Miami, Florida, 33144

  • Lexicon Investigational Site

    Miami, Florida, 33174

  • Lexicon Investigational Site

    Ormond Beach, Florida, 32174

  • Lexicon Investigational Site

    Salt Lake City, Utah, 84102

  • Lexicon Investigational Site

    Scottsdale, Arizona, 85258

  • Lexicon Investigational Site

    Tucson, Arizona, 85741

  • Lexicon Investigational Site

    Victoria, Texas, 77901

  • Lexicon Investigational Site

    Wauconda, Illinois, 60084

  • Lexicon Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

Czechia6 sites

  • Lexicon Investigational Site (138)

    Choceň, 565 01

  • Lexicon Investigational Site (140)

    Pardubice, 53002

  • Lexicon Investigational Site (136)

    Prague, 100 00 00

  • Lexicon Investigational Site (137)

    Prague, 12000

  • Lexicon Investigational Site (141)

    Prague, 13000

  • Lexicon Investigational Site (135)

    Prague, 16000

Other trials in Czechia

Poland4 sites

  • Lexicon Investigational Site (128)

    Katowice, 40-282

  • Lexicon Investigational Site (130)

    Katowice, 640-748

  • Lexicon Investigational Site (134)

    Lublin, 20-064

  • Lexicon Investigational Site (133)

    Warsaw, 01-868

Other trials in Poland

About this study

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)

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

Being tested
Placebo, LX9211
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    LX9211 matching-placebo, tablets will be administered orally.

  • LX9211Drug

    LX9211 tablets will be administered orally.

Study groups in NCT04662281
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing 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.
Receives: Drug: Placebo
LX9211ExperimentalFollowing 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.
Receives: Drug: LX9211

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS)

    ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicates a worse outcome. Negative change from baseline indicates no pain.

    Measured: Baseline (Week 2 of the Run-in period) to Week 6

Secondary outcomes (8)

  1. Change From Baseline in Pain Interfering With Sleep Based on Question 9F of the ZBPI at Week 6

    Pain interfering with sleep is based on Question 9F of the ZBPI "Indicate the one number that describes how, in the past 24-hours shingles pain has interfered with your: Sleep; 0 = does not interfere to 10 = Completely interferes. Higher the number, the worsening of sleep due to pain interference. Negative change from baseline indicates no interference in sleep. Pain interfering with sleep was based on the daily pain diary data based on Q 9F of the ZBPI.

    Measured: Baseline to Week 6

  2. Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline at Week 6

    ADPS is based on question 5 of Zoster Brief Pain Inventory (ZBPI) and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome.

    Measured: Baseline to Week 6

  3. Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6

    ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine. Higher ADPS scores indicated a worse outcome.

    Measured: Baseline to Week 6

  4. Change From Baseline in Interference in General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life Interference Based on the Questions 9A-G of the ZBPI

    The ZBPI, a 9-item questionnaire, assesses the severity of pain and its impact on functioning in participants with postherpetic neuralgia (PHN). Each question concerning daily activity (General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life) was scored on a scale from 0 to 10, where 0 indicated no interference and 10 indicated complete interference. Higher ZBPI score indicates a worse outcome. Negative change from baseline indicates no interference in all daily activities. The pain interference at Week 6 in this outcome measure was based on data collected on the ZBPI administered at the Week 6 in-person clinic visit.

    Measured: Baseline to Week 6

  5. Number of Participants Discontinuing Treatment Due to Lack of Efficacy Defined as Increase in ADPS From Baseline of ≥30% Based on Question 5 of the ZBPI

    ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.

    Measured: Baseline to Week 6

  6. Patient Global Impression of Change (PGIC) at Week 6

    PGIC is assessed on a 7-point rating scale where 1= very much improved to 7 = very much worse. Higher scores indicate worse outcomes.

    Measured: Baseline to Week 6

  7. Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving ≥30% Reduction in Pain Intensity in ADPS Based on Question 5 of the ZBPI.

    ADPS is based on question 5 of ZBPI and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.

    Measured: Week 6 to Week 11

  8. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Adverse Events (AEs) are defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs reported after the first dose of double-blind study medication on study Day 1.

    Measured: From first dose of study drug up to end of double-blind treatment period (up to Week 6) and end of single-blind treatment period (up to Week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start10 Dec 2020
  3. Primary completion18 Nov 2022
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04662281
Sponsor's protocol ID
LX9211.1-202-PHN
Other IDs
2020-004639-26
Acronym
RELIEF-PHN1
Status last verified
Jan 2026
First submitted
4 Dec 2020
Last updated
13 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.

Publications

  • Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8.

    PubMed 35257579

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LX9211 in people with Postherpetic Neuralgia, run by Lexicon Pharmaceuticals at 32 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (Week 2 of the Run-in Period) in Average Daily Pain Score (ADPS) (time frame: Baseline (Week 2 of the Run-in period) to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04662281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in