| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061536 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess rasagiline as a disease modifying therapy in early PD |
|
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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
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 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.
|
|
| E.4 | Principal 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.
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 patients whose BP is not well controlled and is unstable 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 < 26.
15. Subjects with clinically significant psychiatric illness, including major depression
[Beck (short form) depression scale >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 (including multivitamin complexes
containing coenzyme Q10) within 120 days prior to baseline.
19. Subjects who have used sympathomimetics (including over-the-counter
remedies – nasal or oral), dextromethorphan, pethidine or St. John’s Wort
within the 7 days prior to baseline.
20. Subjects who have used antidepressants, including selective serotonin reuptake
inhibitors, tricyclic and tetracyclic antidepressants (except: amitriptyline ≤ 50
mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100
mg/daily and paroxetine ≤ 30 mg/daily, escitalopram ≤ 10 mg/daily) within 42
days prior to baseline.
21. Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days
prior to baseline.
22. Subjects who have used MAO inhibitors including reserpine, methyldopa within
the three months prior to baseline, or treatment with an anti-emetic or
antipsychotic medication with central dopamine antagonist activity (except
quetiapine fumarate) within the six months prior to baseline.
23. Women who are not postmenopausal, surgically sterilized, or using adequate
birth control. Women of childbearing potential without a negative pregnancy test
(serum beta-HCG) at screening.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The change from baseline to each of visit weeks 42, 48, 54, 60, 66 and 72 in the active-treatment phase in Total UPDRS scores. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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