An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias - ND

Conditions: pazienti conmalattia di Parkinson con discinesie indotte dalla L-dopa.
MedDRA version: 9.1Level: PTClassification code 10043118

Registration Number: EUCTR2010-019418-25-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 244

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 < 20 pg/mL if applicable) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. • Outpatients, residing in the community (nursing home patients are not allowed) • Provide written informed consent before any assessment is performed and before any openlabel study drug is taken • Have a caregiver/family informant unless the investigator considers support not to be necessary
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.