An Open Label, Prospective, Non Randomised, Single Arm Pilot Clinical Study to Evaluate the Safety, Tolerability and Effectiveness of AFO-202 strain of Aureobasidium pullulans produced Î² 1,3-1,6 Glucans in Patients with Parkinsonâ??s Disease

ichiIn Bio Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年5月30日

试验速览

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•1.Adults aged >=18 years, diagnosed with Parkinsonâ??s Disease
•2.Subjects with Parkinsonâ??s Disease that meet the clinical diagnostic criteria of the brain bank of the Parkinsonâ??s Disease Association of the United Kingdom.
•3.Subjects who have been on the same treatment regimen for a minimum of three months prior to enrolment and are willing to not make major changes to their standard treatment regimen until the end of the treatment period.
•4.Subject/Caregiver/LAR who will be answering the evaluation questions must have the basic computer literacy to be able to use Google Forms
•5.Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
•6.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

•1.Subjects with advanced stage disease
•2.Subjects with history that suggests possible allergic reaction to the key constituents of the investigational product.
•3.Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible
•4.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
•5.Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interfere with the parameters of the clinical study.
•6.Subjects with CKD or other diseases that impair normal kidney function.
•7.Subjects with known history of clinically significant endocrine, gastrointestinal,cardiovascular,hematological,hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology or co-morbid to the study indication.
•8.Females who are pregnant or lactating or planning to become pregnant during the study period.
•9.Subjects who are currently participating or have participated in a clinical trial upto 90 days prior to randomisation
•10.Subjects, who in the opinion of the investigator are unsuitable for enrolment.

发起方

ichiIn Bio Sciences Pvt Ltd