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).
- Conditions
- Postherpetic NeuralgiaMedDRA version: 21.1Level: PTClassification code 10036376Term: Post herpetic neuralgiaSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-004639-26-PL
- Lead Sponsor
- exicon Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 74
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
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, def
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of LX9211 in reducing pain related to postherpetic neuralgia (PHN);Secondary Objective: To assess other effects and patient reported outcomes of LX9211 versus placebo during and following the Week 6 double-blind Treatment Period;Primary 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]);Timepoint(s) of evaluation of this end point: Week 6
- Secondary Outcome Measures
Name Time Method