JPRN-jRCT2091220080已完成2 期
Double-blind Placebo-controlled Phase 2 Clinical Trial of TAP-144-SR (3M) in patients with Spinal and Bulbar Muscular Atrophy (SBMA) - Phase 2 Clinical Trial of Leuprorelin acetate in patients with SBMA (JASMITT-2)
JASMITT Clinical Trial Office0 个研究点目标入组 100 人开始时间: 2012年1月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
The results of this trial showed the similar tendency with the 06 DB trial with regard to the primary endpoint and some of the secondary endpoints. Therefore, the results of both trials appear to be consistent.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 30age old 至 < 70age old（—）
- 性别
- Male
入选标准
- •(1) Male patients who present one or more of the following clinical symptoms attributed to lower motor neuron impairment, and were given a definitive diagnosis by a genetic testing or have not received any genetic testing but were clinically diagnosed with SBMA
- •1) Muscle weakness of extremities
- •2) Bulbar palsy
- •(2) Patients whose screening test (genetic
- •testing) results showed that they bear at least
- •38 of CAG repeats within the AR genes.
- •(3) Patients who are thirty (>=30) to seventy (<70) years of age at the time of informed consent.
- •(4) Patients who do not desire children.
- •(5) Patients whose hepatic and renal functions meet the following criteria:
- •1) AST(GOT): <=4.0xUpper Limit of Institutional Reference Value
- •2) ALT(GPT): <=4.0xUpper Limit of Institutional Reference Value
- •3) Creatinine: <1.5xUpper Limit of Institutional Reference Value
- •(6) Patients who can keep standing for six minutes without any assistance (Walking aids can be used.)
- •(7) Patients who can undergo admission assessment when study drug administration is perfomed initially (Week 0), Week 48 (last administration) or upon withdrawal.
- •(8) Patients who can visit hospital regularly as an outpatient.
- •(9) Patients who gave written informed consent by themselves.
排除标准
- •(1) Patients who received any of the following twelve months (48 weeks) before giving informed consent: LH-RH agonists, testosterone preparations, 5-alpha reductase inhibitors, anti-androgen preparations, anabolic steroids, progesterone preparations, or unapproved drugs.
- •(2) Patients who have received LH-RH agonists if they will be enrolled in this trial as previously treated cases. Patients who have received LH-RH agonists over thirty six months (144 weeks) in total if they will be enrolled in this trial as untreated cases.
- •(3) Patients who have received a surgical treatment (such as castration) that would cause a decrease in the serum testosterone level.
- •(4) Patients who may not be able to undergo scrotal skin biopsy (e.g. those with scrotal skin disease, those who are susceptible to haemorrhage or allergic to xylocaine).
- •(5) Patients who have no swallowing dysfunction by any of following evaluations. (Index for swallowing function, QOL evaluation for swallowing function, and evalution of swallowing function in videofluorography)
- •(6) Patients who may not be able to undergo videofluorography (e.g. those with severe bulbar palsy causing recurrent aspiration pneumoniae, those with other neurological disorders accompanied by bulbar palsy or pseudobulbar palsy, or those who are allergic to barium sulfate).
- •(7) Patients who are diagnosed with suspected depression by the Mini-International Neuropsychiatric Interview (M.I.N.I. Japanese version 5.0.0 Major Depression Episode)
- •(8) Patients who developed serious complication (such as those corresponding to Grade 3 Episode)
- •(9) Patients who have experienced angina pectoris or myocaridal infarction within one month before giving informed consent.
- •(10) Patients who meet any of the following: Pulse of over 120 beats per minute, systolic blood pressure of over 180mmHg, diastolic blood pressure of over 100mmHg.
研究者
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