An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study

Parkinson*s disease is a progressive neurological disease, characterized by
tremor, muscle rigidness, slowness in movement and loss of balance. Most of the
available medications for Parkinson*s disease are symptomatic therapies. These
therapies provide effective control of symptoms, particularly in the early
phases of the disease.
Rasagiline is a potent, selective irreversible inhibitor of the enzyme
monoamine oxidase B (MAO-B). The inhibition of this enzyme, that metabolizes
dopamine in the human brain, raises the levels of dopamine. Preclinical studies
using multiple experimental models have also shown that, independent of its
MAO-B inhibitory activities, rasagiline is able to protect neurons against
injuries and stress.

The results of the ADAGIO study suggested that Azilect 1 mg may have a
beneficial effect on the clinical progression of Parkinson*s disease. This
study will follow up on the long term clinical condition of subjects who
participated in the ADAGIO study.

- To investigate whether the effect of early-start rasagiline treatment
(according to the ADAGIO study protocol) provided long term benefits over
delayed-start.
- To investigate the long-term effects of rasagiline in PD subjects who
participated in the ADAGIO study and have continued on rasagiline treatment.

This is an open-label, multi-center, follow-up study.
Eligible subjects, who participated in the ADAGIO trial, and who sign an
approved informed consent form, will be enrolled into the study by their
original centers and will continue to receive 1 mg rasagiline once a day.
Tablets will be supplied by the Sponsor and given according to the local label.
Study drug will be dispensed every 3, 6 or 12 months (as permitted and decided
at each site).
Use of any other anti-PD treatments is permitted as deemed necessary by the
treating physician (according to the subject's clinical status). Subjects will
be followed for AE and various aspects of disease progression every three
months, for up to two years in two visit types: short and long visits. Short
visits will be conducted either over the phone or as on-site visits at the
discretion of the investigator. Long visits will be conducted annually
on-site.

Subjects who stop rasagiline treatment during the study will continue to be
followed as per the protocol (according to their willingness). The data
collected will be assessed every six months, and based on this analysis it will
be decided if to continue with the follow-up study.

All participants in the study will receive the same dose of rasagiline, and
will take one tablet per day. In addition the subjects will be able to receive
other treatments for Parkinson*s disease as deemed appropriate by their study
physician.

The following side effects have been reported in placebo controlled clinical
trials:
Very common (more than 10% of the patients): Abnormal movements (dyskinesia),
headache
Common (between 1-10% of the patients): Abdominal pain, accidental injury
(primary falls), allergic reaction, fever, flu syndrome, malaise, neck pain,
chest pain (angina pectoris), low blood pressure when rising to a standing
position (postural hypotension), anorexia, constipation, dyspepsia, dry mouth,
vomiting, abnormal results of blood tests (leucopenia), joint pain
(arthralgia), arthritis, inflammation of tendon (tenosynovitis), weight loss,
abnormal dreams, difficulty in muscular co-ordination (ataxia), depression,
vertigo, prolonged muscle contractions (dystonia), rhinitis, contact
dermatitis, rash, blistering rash (vesiculobullous rash), blood-shot eyes
(conjunctivitis), urinary urgency
Uncommon (between 0.1-1% of the patients): Stroke (cerebrovascular accident),
heart attack (myocardial infarct)
In addition, skin cancer was reported in around 1% of patients in the placebo
controlled clinical trials. Nevertheless, scientific evidence suggests that
Parkinson*s disease, and not any drug in particular, is associated with a
higher risk of skin cancer (not exclusively melanoma).
Parkinson's disease is associated with symptoms of hallucinations and
confusion. In post marketing experience these symptoms have also been observed
in Parkinson's disease patients treated with rasagiline. Rasagiline can
increase the effect of certain drugs including over the counter cough and cold
remedies, leading to serious elevations of blood pressure. Rasagiline may have
the potential to interact with some anti-depressants. This drug interaction may
lead to mild symptoms such as upset stomach, sleep difficulty, restlessness, or
agitation. In rare cases the symptoms may be severe and include loss of
balance, muscle spasms, seizures (convulsions), possible kidney damage, and
even death.