Role of citicoline as supportive therapy in Parkinson’s disease. - CITIPARK

PIAM FARMACEUTICI S.P.A.0 个研究点目标入组 474 人开始时间: 2020年11月4日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•1.Outpatients of both genders older than 60 years and with Parkinson’s disease;
•2.Disease stage between 1.5 and 3 of the Hoehn and Yahr scale;
•3.Stable therapy with Levodopa in the 4 week prior to V0; the maximum daily dosage allowed is 2 g/day in accordance with the standard guidelines;
•4.Stability of therapy with other dopaminergic or other anti-Parkinson drugs (e.g. DA/L Dopa, COMT inhibitors, Rasagiline, etc.) in the 4 week prior toV0; the dosage of these medications must be within the maximum daily dosage allowed in accordance with the guidelines.
•5.A stable disease without motor fluctuations in the 4 weeks prior to V0.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 374

•1.Presence of ON-OFF phenomenon and dyskinesias;
•2.Presence of any degenerative pathology different from Parkinson’s disease (whose effects may generate confounding on the study’s outcomes);
•3.Presence of any dementia (according to the DSM-IV) which might make the patient unable to follow the study’s procedures (e.g. questionnaire or self-assessment scales);
•4.Bleeding diathesis caused by any pathology (e.g liver cirrhosis) or treatment with anticoagulants and/or antiplatelet medications, which would contraindicate the chronic treatment with injectable medications.
•5.Unstable treatment with cholinergic medications (either cholinomimetics or anticholinergic) since at least 3 months prior to the inclusion into the study;

发起方

PIAM FARMACEUTICI S.P.A.