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

Conditions: Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 12.1Level: LLTClassification code 10013916Term: Dyskinesia

Registration Number: EUCTR2010-019418-25-FI

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 244

Inclusion Criteria

Group 1 patients
1.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
2.Have completed the core study
3.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.
4.Outpatients, residing in the community (nursing home patients are not allowed)
5.Provide written informed consent before any assessment is performed and before any open-label study drug is taken
6.Have a caregiver/family informant unless the investigator considers support not to be necessary

Group 2 patients
1.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
2.Have completed the core study
3.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 screening visit of this study.
4.Outpatients, residing in the community (nursing home patients are not allowed)
5.Provide written informed consent before any assessment is performed and before any open-label study drug is taken
6.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

Group 1 patients
1.A score of 5 in the ON-state on the Modified Hoehn and Yahr Staging (UPDRS Part V) assessment at baseline
2.Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
3.Malignancy of any organ system (other than localized basal cell carcinoma of the skin or non-invasive, 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.
4.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)
5.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
6.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)
7.Any patient unable or unwilling to participate in all study-related activities

Group 2 patients
1.A history of surgical treatment for PD, including deep brain stimulation
2.A score of 5 in the ON-state on the Modified Hoehn and Yahr Staging (UPDRS Part V) assessment at screening
3.Any advanced, severe or unstable disease (other than PD) that may interfere with the primary and secondary study outcome evaluations
4.Malignancy of any organ system (other than localized basal cell carcinoma of the skin or non-invasive, 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.
5.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)
6.Treatment with any of the following prior to baseline visit
•current treatment with concomitant medications that are strong or moderate inhibitors or inducers of CYP3A4 within 1 week (see Appendix 2)
•centrally acting anti-cholinergic medication within 3 days
•amantadine within 3 days
•metoclopramide within 3 days
•typical or atypical neuroleptic agents within 1 week
•other investigational drugs within 30 days or 5 half-lives of the BL visit, whichever is longer
7.Laboratory values at screening that include AST, ALT, total bilirubin or creatinine = 1.5 X ULN (upper limit of normal) for the central laboratory
8.Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening (Fridericia's corrections used)
9.Any patient unable or unwilling to participate in all study-related activities