ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/21/2016 |
Start Date: | July 2009 |
End Date: | March 2013 |
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
Eligible participants, who participated in the ADAGIO trial and who sign an approved
informed consent form, will be enrolled into the study at their original study locations.
participants who have stopped rasagiline therapy and in the opinion of the investigator will
gain clinical benefit from restarting treatment can also be considered for enrollment in the
Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed
necessary by the treating physician (according to the participants clinical status).
informed consent form, will be enrolled into the study at their original study locations.
participants who have stopped rasagiline therapy and in the opinion of the investigator will
gain clinical benefit from restarting treatment can also be considered for enrollment in the
Core follow-up study period. Use of any other anti-PD treatment is permitted as deemed
necessary by the treating physician (according to the participants clinical status).
Inclusion Criteria:
1. Subjects who participated in the ADAGIO study, and who entered the active phase of
the study and
2. Subjects who are currently on rasagiline treatment (or subjects who have stopped
rasagiline treatment, are willing to restart treatment, and in the opinion of the
investigator will gain clinical benefit from restarting treatment) and
3. Subjects with a diagnosis of Parkinson's disease and
4. Subjects willing and able to give written informed consent
Exclusion Criteria:
1. Subjects who have discontinued rasagiline treatment due to an adverse event and have
not restarted rasagiline treatment subsequently.
2. Subjects who cannot be given rasagiline due to any exclusion based on the local label
(including pregnancy or nursing women) or due to the use of medications
contraindicated for concomitant use with rasagiline according to local label
3. Subjects with a medical condition that is considered by the investigator as
significant enough to prevent participation
We found this trial at
36
sites
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