Does rasagiline (Azilect) have neuroprotective effects in patients with Parkinson disease (PD)?

Updated: Jan 24, 2019
  • Author: Robert A Hauser, MD, MBA; Chief Editor: Selim R Benbadis, MD  more...
  • Print
Answer

Rasagiline (Azilect) is also an MAO-B inhibitor that exhibits neuroprotective effects in cell culture and animal models. Possible disease-modifying effects of rasagiline were studied in 2 large, delayed-start studies. In such studies, subjects are randomized to treatment with active study medication or to placebo followed by active study medication. This creates 2 phases within the study. In phase I, one group is on placebo, and the other is on active study medication; in phase II, both groups are receiving active study medication. If phase II is long enough to allow full wash-in of symptomatic effects, any differences between the groups at the end of the study should be due to enduring benefits (ie, disease modification) that accrue only to the group that received active study medication during phase I.

Stated another way, in a delayed-start design, half of the subjects in the study take the trial drug from day 1 and the other half take placebo. However, halfway through the study, the placebo group is switched from placebo to the trial drug. If the drug is truly beneficial in slowing progression of the disease, those that started the trial on placebo should never catch up, in terms of disease progression, to those who were given the trial drug from the beginning of the study.

ADAGIO and TEMPO studies

In October 2011, the US Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee voted against approval of an indication for disease-modifying effects for rasagiline. The advisory committee determined that the 2 delayed-start rasagiline studies did not provide compelling evidence that rasagiline slows progression of Parkinson disease. These trials were the ADAGIO (Attenuation of Disease progression with Azilect Given Once-daily) [68, 69] and TEMPO (Rasagiline in Early Monotherapy for Parkinson's Disease Outpatients) [70, 71] studies, which are discussed below.


Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!