Status:
TERMINATED
Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease
Lead Sponsor:
Qualissima
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Early-stage Parkinson's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Title: Evaluation of the tolerance and acceptability of Rasagiline in the treatment of early-stage Parkinson's disease. Type of study: Phase IV Study objectives: Principal objective: To evaluate t...
Eligibility Criteria
Inclusion Criteria:
-
male or female aged between 18 and 70
-
capable of reading and understanding the information leaflet given to him/her
-
signed an inform consent form
-
presenting with idiopathic Parkinson's disease with a Hoehn and Yahr score of ≤ 3
-
has never been given anti-Parkinson medication, or has been treated with L-Dopa, on condition that the total duration of treatment was less than twelve weeks at a dosage of under 200 mg, or has been treated with a dopamine agonist other than Pramipexole, on condition that:
- either the patient is still in the dose-titration phase at the time of inclusion
- or that the treatment was administered for less than six weeks and was completed two weeks before inclusion
Exclusion Criteria:
- women who are pregnant, breastfeeding, or planning a pregnancy in the months after joining the study
- women of reproductive age who have not undergone surgical sterilisation or who are not using a reliable method of contraception before joining the study and during the study
- patient presenting with hepatic insufficiency
- patient presenting with a concommitant illness which is considered significant by the investigator, after examination of the history, the patient's clinical condition, or on the basis on any additional examinations performed
- patient presenting with a skin lesion considered to be suspect by the investigator and which has not been evaluated by a dermatologist
- patient presenting with a contraindication to treatment with Rasagiline or Pramipexole (please see the SPC for the respective products)
- patient treated with fuoxetine during the five weeks preceding inclusion
- patient treated with fluvoxamine, pethidine, selegiline or any other MAOI during the two weeks preceding inclusion
- patient who has had deep brain stimulation treatment
- patient who might receive dextromethorphan or a sympathomimetic during the study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01048229
Start Date
October 1 2008
End Date
March 1 2010
Last Update
May 28 2012
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