Parkinson's disease MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: CITICOLIN*1G/4ML IM IV 5 F
Product Name: Citicolina 1000 mg/die
Product Code: [citicolin]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CITICOLINA SODICA
CAS Number: 338
Sponsors
PIAM FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To demonstrate the efficacy of citicoline in improving the quality of life; - To demonstrate the efficacy of citicoline on both motor and non-motor symptoms of Parkinson’s disease in patients treated with dopaminergic therapy; - To assess the safety of citicoline in patients treated with dopaminergic therapy. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The improvement on the Quality of life (QoL-30), assessed at the end of the second treatment cycle (V4,T24) versus the baseline (T0).; Evaluation of clinical improvement measured with the part II and part III of the CGI scale, assessed at the end of the second treatment cycle (V4,T24) versus baseline (T0).; Changes in the total score and in the sub-scale scores of PDQ39, CGI part I and NMSS scales, at the end of the second treatment cycle (V4,T24) versus baseline(T0).; Changes in the total score and in the sub-scale scores of MDS-UPDRS scale at the end of the treatment period of the first cycle (V1,T6) versus baseline (V0,T0) to assess the short-term effect.; Changes in the total score and in the sub-scale scores of MDS-UPDRS scale at the end of the first cycle (V2,T12) versus baseline (V0,T0), to assess the short-term effect after a discontinuation period.; Changes in the total score and in the sub-scale scores of MDS-UPDRS scale between the end of treatment on the first cycle (V1,T6) and the end of the first cycle itself (V2,T12), to assess the effect maintenance after 6 weeks of discontinuation.; Changes in the total score and in the sub-scale scores of MDS-UPDRS scale at the end of treatment on the second cycle (V3,T18) versus baseline (T0), to assess the immediate effect at the treatment end.; Changes in the total score and in sub-scale scores of MDS-UPDRS scale between the end of treatment on the second cycle (V3,T18) and the end of second cycle itself (V4,T24), to assess the effect maintenance after 6 weeks of discontinuation.;Timepoint(s) of evaluation of this end point: assessed at the end of the second treatment cycle (V4,T24) versus the baseline (T0).; assessed at the end of the second treatment cycle (V4,T24) versus baseline (T0).; at the end of the second treatment cycle (V4,T24) versus baseline(T0).; at the end of the treatment period of the first cycle (V1,T6) versus baseline (V0,T0).; at the end of the first cycle (V2,T12) | — |
Countries
Italy
Contacts
Public ContactDr Marco Terrile
PIAM FARMACEUTICI S.P.A.
Outcome results
None listed