EUCTR2020-004639-26-CZ进行中（未招募）1 期
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) - RELIEF-PHN1
exicon Pharmaceuticals, Inc.0 个研究点目标入组 74 人开始时间: 2021年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 birth control methods which may be considered as highly effective, i.e. methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
- •oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- •oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation
- •intrauterine device
- •intrauterine hormone-releasing system
- •bilateral tubal occlusion
- •vasectomized partner
- •sexual abstinence
- •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
排除标准
- •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. Permitted medications include gabapentin, pregabalin, and tricyclic antidepressant medications. 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] and aspirin). 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 withd
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