A Phase 2a Open-Label Study of CNSA-001 in Patients with Parkinson’s Disease

Censa Pharmaceuticals Australia Pty Ltd0 个研究点目标入组 6 人开始时间: 2020年6月12日最近更新: 2021年3月1日

适应症

试验速览

暂无简介。

•Key inclusion criteria include:
•1.Confirmed diagnosis of Parkinson’s Disease
•2.Males and females greater than or equal to 18 years
•3.Females must be either postmenopausal for at least 1 year, or surgically sterile for at least 6 months or, if of childbearing potential and not abstinent, willing to use a combination method of contraception from screening through 30 days after the last dose of study drug
•4.Males (if sexually active and nonsterile) with female partners of childbearing potential must agree to use barrier contraceptive with spermicidal foam from screening through 90 days after the last dose of study drug.
•5.The patient is clinically stable on therapy for management of Parkinson’s Disease, on a stable dose of levodopa or dopamine replacement equivalent medication, but needs more levodopa or dopamine replacement equivalent to control disease.
•6.The patient is willing to refrain from tobacco use

•Key exclusion criteria include:
•1.Weight > 110 kg
•2.Diagnosis of functional (psychogenic) movement disorders
•3.Significant chronic medical illness other than Parkinson’s Disease
•4.Gastrointestinal disease that could affect absorption of the study drug
•5.History of gastric surgery, including Roux-en-Y gastric bypass surgery or an antrectomy with vagotomy, or gastrectomy
•6.Inability to tolerate oral medication
•7.Any medical condition or history that would prohibit the patient from completing a MRI
•8.History of surgical intervention for Parkinson’s Disease
•9.Currently taking an antifolate including, but not limited to, methotrexate, pemetrexed, or trimetrexate

发起方

Censa Pharmaceuticals Australia Pty Ltd