Parkinson's Disease MedDRA version: 7.1 Level: PT Classification code 10061536
Conditions
Interventions
Trade Name: Azilect
Product Name: rasagiline tablets
Product Code: TVP-1012
Pharmaceutical Form: Tablet
INN or Proposed INN: rasagiline
Sponsors
Teva Pharmaceuticals Industries LtD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all the inclusion criteria to be eligible: 1. Men and women with idiopathic Parkinson’s disease whose diagnosis is confirmed at Screening by the presence of at least two of the cardinal signs (resting tremor, bradykinesia, rigidity), without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry. 2. Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis. 3. Subjects whose clinical condition at the time of study enrollment does not require any anti-PD treatment and, to the best of the investigator’s judgment, will not require for the next 9 months. 4. Willing and able to give informed consent. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following will exclude the subject from the study: 1. Subjects younger than 30 or older than 80 years of age. 2. Subjects with a loss of postural reflexes. 3. Subjects with a UPDRS Tremor score of 3 or greater in any limb. 4. Subjects with a Hoehn &Yahr stage of III or greater at screening. 5. Subjects with freezing while walking. 6. Subjects with any one of the following features that tend to exclude PD as the cause of Parkinsonism: - - History of repeated strokes with stepwise progression of Parkinsonian features - History of repeated head injury or history of definite encephalitis - Sustained remission - Supranuclear gaze palsy - Cerebellar signs - Early severe autonomic involvement - Babinski’s sign - Presence of a cerebral tumour or communicating hydrocephalus - MPTP exposure - Oculogyric crises 7. Subjects who have had any previous use of rasagiline or selegiline. 8. Subjects having used any other anti-PD medication (including anticholinergics) on a chronic (for more than 3 weeks) basis at any time prior to baseline. 9. Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline (not including a single L-Dopa dose as part of L-Dopa test). 10. Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti- PD medication is intentionally ceased in order for the subject to enter the study. 11. Subjects who, based on the investigator’s judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions may include cardiovascular, vascular disease, pulmonary, hepatic impairment (Child-Pugh Score >5), renal, or metabolic diseases or malignancies as determined by medical history, physical examination, aboratory tests, chest x-ray, or ECG. 12. Hypertensive subjects whose BP, in the investigator’s opinion, is not well controlled according to the subject’s medical record or as observed during the week of home BP recording prior to baseline. 13. Subjects diagnosed with melanoma based on the screening dermatologic examination, or with a history of melanoma. Subjects with suspicious lesions at baseline who do not undergo biopsy. 14. Subjects with significant cognitive impairment as defined by MMSE score 15] . 16. Subjects with a history of alcohol or substance abuse within the past 2 years. 17. Subjects who have taken any experimental medications within 60 days prior to baseline. 18. Subjects who have used coenzyme Q10 (in daily doses > 300
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess rasagiline as a disease modifying therapy in early PD;Secondary Objective: ;Primary end point(s): The change from baseline in Total UPDRS scores. | — |
Countries
Austria, Germany, Hungary, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed