“We are pleased with the results of the study as they reinforce the efficacy and tolerability profile we’ve seen in the clinical development programme for Azilect,” said Anders Gersel Pedersen, Executive Vice President, Research & Development at H. Lundbeck A/S. “ANDANTE exemplifies
Lundbeck’s long-term commitment to championing treatment advances that meet the specific needs of the CNS communities we serve, including patients, healthcare providers, care partners and advocates.”
The results of the study will be presented today as part of the Emerging Science program (formerly known as Late-Breaker Science) at the 65 th American Academy of Neurology (AAN) Annual Meeting in San Diego, Calif. on Wednesday, March 20, 2013. Full data from the study will be submitted for publication.
STUDY DETAILSANDANTE was an 18-week, double-blind, placebo controlled, randomized, multi-center study assessing the safety and clinical benefit of rasagiline compared to placebo as add-on therapy to stable dose of dopamine agonists (DAs) in the treatment of early PD. In addition to the above stated primary endpoint results, data from the secondary endpoint analysis showed the addition of Azilect ® resulted in a statistically significant improvement in the UPDRS motor examination subscale (Part III) (p=0.007). There were no significant differences between groups for the UPDRS activities of daily living (ADL) (p=0.301) or CGI-I scores. Azilect was well-tolerated in the study. ANDANTE was conducted at 50 research sites in the United States. A total of 328 patients on sub-optimal DA monotherapy randomized into the study to add-on treatment with Azilect (N=163) or placebo (N=165). Volunteers returned to the clinic at nine weeks for an interim visit and again at 18 weeks, for an end of study visit. To be enrolled patients needed to be on a stable DA monotherapy for ≥ 30 days. Patients included could not receive an optimal therapeutic dose of DAs due to intolerable side effects or were no longer experiencing sufficient control of their PD symptoms and required an additional therapeutic agent. Rescue treatment with levodopa was allowed once the patient had started treatment with study drug and had completed four weeks of treatment. DA therapy could not be adjusted during the study.