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    Summary
    EudraCT Number:2020-004639-26
    Sponsor's Protocol Code Number:LX9211.1-202-PHN
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004639-26
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To evaluate how well study drug LX9211 is in reducing pain related to postherpetic neuralgia (PHN), a painful condition that affects the nerve fibers and skin (shingles).
    A.3.2Name or abbreviated title of the trial where available
    RELIEF-PHN1
    A.4.1Sponsor's protocol code numberLX9211.1-202-PHN
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04662281
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLexicon Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLexicon Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLexicon Pharmaceuticals
    B.5.2Functional name of contact pointVice President, Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address2245 Technology Forest Blvd, Level 11
    B.5.3.2Town/ cityThe Woodlands, Texas
    B.5.3.3Post code77381-5261
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 281-863-3000
    B.5.5Fax number+1 281-863-8088
    B.5.6E-mailclinicaloperations@lexpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code LX9211 Phosphate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLX9211 Phosphate
    D.3.9.1CAS number 1815613-42-3
    D.3.9.2Current sponsor codeLX9211 Phosphate
    D.3.9.3Other descriptive name(S)-1-((2',6-bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-aminium dihydrogen phosphate
    D.3.9.4EV Substance CodeSUB218855
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code LX9211 Phosphate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLX9211 Phosphate
    D.3.9.2Current sponsor codeLX9211 Phosphate
    D.3.9.3Other descriptive name(S)-1-((2',6-bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-aminium dihydrogen phosphate
    D.3.9.4EV Substance CodeSUB218855
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postherpetic Neuralgia
    E.1.1.1Medical condition in easily understood language
    A painful condition that affects the nerve fibers and skin. It is a complication of shingles, and shingles is a complication of chicken pox.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of LX9211 in reducing pain related to postherpetic neuralgia (PHN)
    E.2.2Secondary objectives of the trial
    To assess other effects and patient reported outcomes of LX9211 versus placebo during and following the Week 6 double-blind Treatment Period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has given written informed consent to participate in the study in accordance with local regulations
    2. Adult male or female patients ≥18 years of age at the Screening Visit:
    a. Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug. In the case of positive urine pregnancy testing, a negative serum sample for pregnancy testing, to confirm that the patient is not pregnant, must be obtained prior to start of study. They must also agree to use adequate methods of contraception which include the following: condom with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depo-progesterone injections, progesterone implant (ie, Implanon®), NuvaRing®, Ortho Evra®
    b. Nonsterile male patients with sexual partners of childbearing potential must agree to use adequate methods of contraception from Baseline through the Week 11 Visit
    3. Presence of 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)
    4. Moderate to severe pain as confirmed by average pain score using scores recorded in the pain diary in the 14 days prior to randomization (Run-in Period)
    5. At least 80% compliance with dosing during the 2-week Run-in Period, and 70% compliance with completion of the daily diary during the second week of the Run-in Period
    6. Willing to adhere to the prohibitions and restrictions specified in the protocol
    E.4Principal exclusion criteria
    1. Presence of other painful conditions that may confound assessment or self-evaluation of PHN:
    a. Patient should not have any other neurological disorder or conditions that can cause symptoms that may mimic peripheral neuropathy or that might confound assessment of PHN pain.
    b. Other causes of diffuse painful peripheral neuropathy such as: paraproteinemia, untreated hypothyroidism (previously treated hypothyroidism not excluded if treated and euthyroid for ≥6 months), vitamin B12 deficiency, neurologically-evident vasculitis, malignancy, amyloidosis, renal insufficiency, connective tissue disease (eg, Sjogren's, systemic lupus erythematosus), porphyria, complex regional pain syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, alcoholism, HIV, hepatitis, uremia, syphilis, myeloma, or other systemic disease associated with a secondary painful neuropathy should be excluded.
    c. Patient should not have had any exposure to drugs/toxic environmental agents known to cause neuropathy
    2. Over the past year, met Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for a major depressive episode, any active, significant psychiatric disorders (eg, neurocognitive disorder, anxiety disorder, psychosis, bipolar disorder), or a history of clinically significant drug or alcohol use disorder that would, in the Investigator's opinion, interfere with the assessment and evaluation of pain during the study
    3. Mood and anxiety disorder scores defined by Hospital Anxiety and Depression Scale (HADS) ≥13
    4. Suspected or likely diagnosis of trigeminal neuralgia
    5. Use of opioid medications for management of PHN within the 2 months prior to the Screening Visit. Note: Brief use (<1 week) of opioid medication for management of non-PHN acute pain (eg, tooth extraction/acute injury) ≥2 months prior to the Screening Visit is permitted.
    6. Use of NSAIDs for the specific treatment of PHN pain.
    7. Use of more than 1 permitted concomitant medications for the treatment of PHN. Note: Patients may washout additional PHN medications ≥1 month prior to the Screening Visit to reach the 1 permitted medication
    8. For non-opioid medications patient uses and is unwilling/unable to discontinue use of prohibited medications and therapies, (eg, benzodiazepines, dextromethorphan, herbal medications, mexiletine HCl, adenosine, topical analgesics including lidocaine and capsaicin), applied to the same area of the body affected by PHN pain, nerve blocks, acupuncture, or other medications indicated for neuropathic pain. A patient using any of these interventions for neuropathic pain must discontinue the medication ≥1 month prior to starting the Screening Period and for the duration of the study. Note: This exclusion criterion does not include analgesics that are not specifically prescribed for treatment of neuropathic pain (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], aspirin, acetaminophen). In addition, patients who are prescribed antidepressants for a mental health disorder are eligible to participate as long as they do not meet Exclusion Criteria 2-3.
    9. A positive urine drug test for drugs of abuse including cannabinoids. Note: Cannabidiol (CBD), if used for mood or sleep, is acceptable. If used for PHN it would be allowed if it is the only concomitant medication being taken for PHN. If not the only medication being taken for PHN, it should be withdrawn ≥1 month prior to Screening
    10. Patient has hepatic impairment at Screening, defined as any of the following: aspartate aminotransferase (AST) >2X upper limit of the normal reference range (ULN), alanine aminotransferase (ALT) >2X ULN, serum total bilirubin (TB) >2X ULN. Note: If it is the opinion of the Investigator and the Medical Monitor that an increase in bilirubin is due to Gilbert’s syndrome, then the patient may participate.
    11. Patient has abnormal kidney function test (estimated glomerular filtration rate [eGFR] <60 mL/min as calculated using the Cockcroft-Gault equation) at Screening or renal dysfunction requiring hemodialysis
    12. Patient has any of the following medical conditions or disorders: epilepsy or seizure disorder requiring treatment with antiepileptic drugs
    13. Presence of clinically significant physical examination (PE) findings other than PHN, or laboratory or ECG findings that in the opinion of the Investigator, Medical Monitor, and/or the Sponsor, may interfere with any aspect of study conduct or interpretation of results including:
    a. any clinically significant abnormal heart rate or rhythm
    b. other ECG abnormalities that are clinically relevant
    c. BP >160/100 mm Hg or <90/50 mm Hg
    d. presence of risk factors for torsade de points (eg, family history of long QT syndrome; personal history of NYHA class III/IV heart failure or structural heart disease)

    Refer to protocol for further criteria
    E.5 End points
    E.5.1Primary end point(s)
    The change from Baseline (Week 2 of the Run-in Period) to Week 6 in Average Daily Pain Score (ADPS), based on Question 5 of the Zoster Brief Pain Inventory (ZBPI), the 11-point numerical rating scale (0 [No Pain] to 10 [Pain as bad as you can imagine])
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    E.5.2Secondary end point(s)
    • Change from Baseline to Week 6 in pain interfering with sleep 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])”
    • Proportion of patients with ≥30% reduction in pain intensity in ADPS based on Question 5 of the ZBPI from Baseline to Week 6
    • Proportion of patients with ≥50% reduction in pain intensity in ADPS based on Question 5 of ZBPI from Baseline to Week 6
    • Change from Baseline to Week 6 in interference in General Activity, Mood, Walking Ability, Normal Work (includes both outside the home and housework), Relations with other people, Sleep, and Enjoyment of Life interference based on the Questions 9A-G of the ZBPI
    • Proportion of patients discontinuing treatment due to lack of efficacy defined as increase in ADPS from Baseline of ≥30% based on Question 5 of the ZBPI
    • Patient Global Impression of Change (PGIC) at Week 6
    • Time to loss of efficacy from Week 6 to Week 11 among patients achieving ≥30% reduction in pain intensity in ADPS based on Question 5 of the ZBPI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    To Week 6
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Poland
    Czechia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 74
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-21
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