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