pazienti con malattia di Parkinson con discinesie indotte dalla L-dopa. MedDRA version: 9.1 Level: PT Classification code 10043118
Conditions
Interventions
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Code: AFQ056
Pharma
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must fulfill all of the following criteria: • Must have been eligible for the core study i.e. must have met inclusion and not met any exclusion criteria at the time of entry into the core study • Have completed the core study • Female patients must be of non-childbearing potential, defined as all women physiologically not capable of becoming pregnant, and must have a negative pregnancy test at the last visit prior to taper-off of the core study (Group 1) or at the screening visit of this study (Group 2). Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL (and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are excluded from the study: Group 1 patients • A score of 5 in the ``ON``-state on the Modified Hoehn and Yahr Staging (UPDRS Part V) assessment at baseline • Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations • Malignancy of any organ system (other than localized basal cell carcinoma of the skin or noninvasive, non-metastatic prostate cancer that has been effectively treated), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. • Evidence of dementia (or MMSE = 26 at the baseline visit) untreated or ineffectively treated major depressive disorder; currently experiencing hallucinations/psychosis requiring antipsychotic treatment, and/or confusional states (DSM-IVR, Diagnostic and Statistical Manual of Mental Disorders, 4th edition, revised) • Lab values (at the last visit prior to the taper-off period of the respective core study or at any subsequent unscheduled visit prior to the baseline visit) that include AST, ALT, total bilirubin or creatinine = 1.5 X ULN (upper limit of normal) for the central laboratory • Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at the last visit prior to taper-off of the core study (Fridericia`s corrections used) • Any patient unable or unwilling to participate in all study-related activities Group 2 patients • A history of surgical treatment for PD, including deep brain stimulation • A score of 5 in the ``ON``-state on the Modified Hoehn and Yahr Staging (UPDRS Part V) assessment at screening • Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations • Malignancy of any organ system (other than localized basal cell carcinoma of the skin or noninvasive, non-metastatic prostate cancer that has been effectively treated), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. • Evidence of dementia (or MMSE = 26 at the screening visit); untreated or ineffectively treated major depressive disorder; currently experiencing hallucinations/psychosis requiring antipsychotic treatment, and/or confusional states (DSM-IVR, Diagnostic and Statistical Manual of Mental Disorders, 4th edition, revised) • Treatment with any of the following prior to baseline visit o treatment with concomitant medications that are strong or moderate inhibitors or inducers of CYP3A4 within 1 week (see Appendix 2) o centrally acting anti-cholinergic medication within 3 days o amantadine within 3 days o metoclopramide within 3 days o typical or atypical neuroleptic agents within 1 week o other investigational drugs within 30 days or 5 half-lives of the BL visit, whichever is longer • Laboratory values at screening that include AST, ALT, total bilirubin or creatinine = 1.5 X ULN (upper limit of normal) for the central laboratory • Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening (Fridericia`s corrections used) • Any patient unable or unwilling to participate in all study-related activities No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: To evaluate the safety and tolerability of AFQ056 in patients with PD-LID as assessed by: • Incidence and severity of adverse events and serious adverse events • Changes in vital signs, laboratory assessments, and ECGs • Changes in cognitive function as measured by the MMSE • Changes in psychiatric symptoms as measured by the SCOPA-PC • Changes in underlying symptoms of PD as measured by the UPDRS part III and the PD symptom items in the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC), and by AEs potentially related to an exacerbation of movement disorder of PD • Occurrence of rebound symptoms upon discontinuation of study drug;Secondary Objective: Secondary objectives: To evaluate the anti-dyskinetic efficacy of AFQ056 treatment in patients with PD-LID on dyskinesia as assessed by • Change from baseline in mAIMS total score • Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively;Primary end point(s): To evaluate the safety and tolerability of AFQ056 in patients with PD-LID as assessed by: • Incidence and severity of adverse events and serious adverse events • Changes in vital signs, laboratory assessments, and ECGs • Changes in cognitive function as measured by the MMSE • Changes in psychiatric symptoms as measured by the SCOPA-PC • Changes in underlying symptoms of PD as measured by the UPDRS part III and the PD symptom items in the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC), and by AEs potentially related to an exacerbation of movement disorder of PD • Occurrence of rebound symptoms upon discontinuation of study drug | — |
Countries
Finland, France, Germany, Italy
Outcome results
None listed