Double-blind Placebo-controlled Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) - JASMITT

JASMITT Clinical Trial Office0 个研究点目标入组 170 人开始时间: 2006年8月24日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Clinically and/or genetically confirmed SBMA male patients in Japan who have more than one symptoms including muscle weakness, muscle atrophy, bulbar palsy and hand tremor.
•2) Patients whose repeat number of CAG in androgen receptor gene is more than 38 in screening gene analysis.
•3) Patients who are age 30 to 70 year-old at the time of informed consent.
•4) Patients who have no desire to father a child.
•5) Patients whose liver function test and renal function test are within below limits. AST (GOT) smaller than 4.0 X upper limit of normal ALT (GPT) smaller than 4.0 X upper limit of normal Creatinine smaller than 1.5 X upper limit of normal
•6) Patients who are capable of standing for 6 min with or without cane.
•7) Patients who are capable of undergoing in hospital examinations at 0, 24th, 48th week and the time of quitting the trial.
•8) Patients who are capable of ambulatory hospital visits.
•9) Patients with written informed consent.

•1) Patients who have taken LH-RH agonists, testosterone drugs, 5-alpha-reductase inhibitors, anti-androgen drugs or estrogen drugs within 48 weeks prior to the informed consent.
•2) Patients who have taken LH-RH agonists for more than 48 weeks prior to the informed consent.
•3) Patients who have undergone operations (eg. orchiectomy), which reduce serum testosterone levels.
•4) Patients who are unable to undergo skin biopsies.
•5) Patients who are unable to undergo videofluorography.
•6) Patients who are diagnosed being depressed by M.I.N.I. Japanese version 5.0.0 major depression episode.
•7) Patients who have severe complications.
•8) Patients who have suffered angina pectoris or myocardial infarction within one month prior to the informed consent.
•9) Heart rate > 120 bpm, systolic BP > 180mmHg or diastolic BP > 100 mmHg.
•10) Patients with past medical history of allergy to leuprorelin acetate, synthetic LH-RH or LH-RH delivatives.
•11) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent.
•12) Patients who are not appropriate to participate to the trial.

发起方

JASMITT Clinical Trial Office