Citicoline as supportive treatment in Parkinson's disease

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005562-30-IT
• Lead Sponsor: PIAM FARMACEUTICI S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

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

Exclusion Criteria

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this post-authorization study is to confirm the clinical efficacy in patients with Parkinson’s disease and treated with dopaminergic therapy after a treatment period of six months with citicoline.;Secondary Objective: Secondary objectives<br>- To demonstrate the efficacy of citicoline in improving the quality of life;<br>- To demonstrate the efficacy of citicoline on both motor and non-motor symptoms of Parkinson’s disease in patients treated with dopaminergic therapy;<br>- To assess the safety of citicoline in patients treated with dopaminergic therapy.<br>;Primary end point(s): The primary efficacy endpoint is defined as the change in the total score of the MDS-UPDRS scale measured at the end of the second cycle (V4,T24) versus baseline (T0) weeks after the treatment starting.;Timepoint(s) of evaluation of this end point: between baseline (T0) and the end of the second cycle (V4,T24), 24 weeks after treatment starting.