Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01048229
• Date of registration: 12/01/2010
• Prospective Registration: No
• Primary sponsor: Qualissima
• Public title: Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease ACTOR
• Scientific title: Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease
• Date of first enrolment: October 2008
• Target sample size: 112
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01048229
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Early-stage Parkinson's Disease

Intervention(s)

Drug: Pramipexole

Drug: Rasagiline

Primary Outcome(s)

frequency of 'significant' adverse events [Time Frame: each visit]

Secondary Outcome(s)

percentage of patients with sleep disorders [Time Frame: each visit]

CGI-I and PGI-I [Time Frame: each visit]

Epworth Sleepiness Scale (ESS) [Time Frame: each visit]

Secondary ID(s)

ACTOR protocol

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

H. Lundbeck A/S