EUCTR2022-000435-23-CZ进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel group, placebo controlled, Phase 2 study to assess the efficacy and safety of ATX01 (topical amitriptyline hydrochloride 10% and 15% w/w) in comparison to placebo, in cancer survivor adult patients with chemotherapy-induced peripheral neuropathy (CIPN) - A multicenter, placebo controlled, Phase 2 study in cancer survivor adult with CIP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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.Male or female patients of 18 years and older.
- •2.Patients having signed a written informed consent prior to any study-related procedure.
- •3.Body mass index (BMI) of 18 and 32 kg/m2 (inclusive).
- •4.With an estimated life expectancy =6 months at study entry.
- •5.Patients with painful sensory CIPN resulting from prior treatment of cancer with taxanes or platins. A diagnosis of CIPN should be supported by i) onset of pain in hands or feet after exposure to taxanes or platins, ii) presence of painful symptoms in a symmetrical stocking and/or glove distribution, AND iii) painful symptoms may be accompanied by nonpainful symptoms (eg, tingling/pins and needles intensity and numbness intensity).
- •6.Patients who have stopped their chemotherapy treatment with taxanes or platins or any other neurotoxic chemotherapy for =24 weeks at the time of the screening visit.
- •7.Patients with CIPN pain for =24 weeks at the time of the screening visit.
- •8.Patients with a mean value of pain intensity =4 and =9 in target study extremities (left and right feet or left and right hands) on the 11-point NPRS at baseline.
- •9.Patients with symmetrical stocking or glove distribution pain, NPRS (=1 point difference) in the target study extremities at screening.
- •10.Neuropathic Pain (Douleur Neuropathique 4 [DN4]) score =4 in the target study extremities (hands or feet) at the screening visit.
- •11.Treatment naïve patients or patients in whom any prior CIPN treatment (except oral AMT) has not been modified during the 4 weeks preceding the screening visit and is planned to be maintained at the same regimen during the course of the study (prior treatment includes pharmacological and nonpharmacological treatments).
- •12.Male patient should agree to use a condom along with another medically acceptable contraceptive method, where applicable according to local guidelines, if he is engaged in sexual activity with a woman of childbearing potential (WOCBP) from the day of the signature of the informed consent and up to 90 days after the End of Study (EoS) Visit. Male patient should agree not to donate sperms until 30 calendar days after the last dose of study drug.
- •13.Females must comply with the following in order to be enrolled:
- •a.WOCBP with negative serum pregnancy test results can be enrolled only if willing to use an acceptable contraceptive method, ie, oral contraceptives, patch contraceptives, injection contraceptives, implantable hormonal contraceptives, male condom with intravaginal spermicide, diaphragm or cervical cap with spermicide, vaginal contraceptive ring, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the patient’s current practice, from at least 14 days prior to the screening visit and throughout the study and for at least 30 days after completion of the study.
- •b.Or surgically sterilized for at least 6 months.
- •c.Or menopausal for at least 1 year.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.Patients who are not compliant in completion of pain ratings during the screening period. Patients having <5 of 7 records of average pain intensity in the target study extremities .
- •2.Clinical evidence of a preexisting painful peripheral neuropathy resulting from another cause than chemotherapy, eg, diabetic neuropathy, posttraumatic neuropathy, carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy, or other preexisting symptomatic neuropathy due to alcoholism, vitamin B deficiency, hypothyroidism, human immunodeficiency virus (HIV).
- •3.Skin abnormality, irritation, or lesions of any type on the hands or feet (or only on the hands if the study drug is not applied on the feet and vice versa [only on the feet if the study drug is not applied on the hands]).
- •4.Presence of glaucoma.
- •5.Presence of urinary retention (or at risk of urinary retention).
- •6.History of coronary artery disease.
- •7.History and/or presence of major depressive episode. Patients with a medical history of bipolar disorder, alcohol abuse, or psychotic disorder.
- •8.Patients at significant risk of suicide, or is a danger to self or others, in
- •the opinion of the investigator, based upon clinical interview and C-SSRS (Affirmative to suicidal ideation Q4 & 5) within the last 6 months.
- •9.Pregnant or lactating women.
- •10.Abnormality in the 12-lead ECG at screening that in the opinion of the investigator increases the risk of participating in the study, such as QTcF interval >430 msec for males or >450 msec for females.
- •11.A history of additional risk factors for Torsade de Pointe (eg, heart failure, hypokalemia, family history of long QT syndrome).
- •12.The use of concomitant medications within 24 weeks prior to Day 1 and/or during the study or the equivalent of 5 half-lives that prolong the QT/QTc interval, eg, Class 1 antiarrhythmics (eg, quinidine, disopyramide, procainamide) and Class 3 antiarrhythmics (eg, amiodarone, sotalol), antihistamines, antipsychotics known to prolong QT interval, and antimalarials (eg, mefloquine, quinine), tricyclic antidepressants (eg, AMT), tetracyclic antidepressants (eg, maprotiline), cisapride.
- •13.The use of Monoamine Oxidase Inhibitors within 24 weeks (or the equivalent of 5 half-lives) prior to Day 1 and/or during the study.
- •14.The use of opioids within 4 weeks (or the equivalent of 5 half-lives) prior to Day 1 and/or during the study.
- •15.History of illicit drug use or confirmed drugs of abuse at screening.
- •16.Patients likely to require neurotoxic chemotherapy treatment or any other treatment during the study, which may interfere with compliance to the protocol, ability to complete the study and study assessments except treatments authorized in inclusion criterion #11.
- •17.Failure to respond to more than 2 analgesics from different drug classes (including antidepressants and anticonvulsants) due to lack of efficacy or intolerability to treat CIPN at any time in the past.
- •18.Treatment with oral or topical AMT or nortriptyline in the past 4 weeks.
- •19.Any known hypersensitivity to AMT in any salt form or to any constituent of the topical formulation.
- •20.Any contraindication to the use of acetaminophen/paracetamol.
- •21.Use of glutathione, vitamin E, minocycline, or calcium magnesium supplements within 12 weeks of screening.
- •22.Any topical treatment on treated extremities for any indication, other than cosmetic use of creams and lotions, within the previous 12 weeks.
- •23.Any topical treatment for pain including use
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