drugset
drugset / Trial / NCT01765257

Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study

NCT01765257 ↗

Phase 4 Unknown 50 enrolled University Hospital, Clermont-Ferrand CHU Purpan (Toulouse) · collabCentre Hospitalier Universitaire de Nīmes · collabCentre Hospitalier Universitaire de Saint Etienne · collabCentre Hospitalier Universitaire, Amiens · collabCentre Hospitalier de la côte Basque · collabCentre Hospitalier du Pays d'Aix · collabFondation Rothschild Paris · collabH. Lundbeck A/S · collabHôpital Dupuytren · collabHôpital Haut-Lévêque · collabHôpital de la Timone (MARSEILLE) · collabPoitiers University Hospital · collabRennes University Hospital · collabUniversity Hospital, Caen · collabUniversity Hospital, Lille · collabUniversity Hospital, Rouen · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.

Timeline

Start
2013-06
Primary completion
2014-12
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rasagiline Small molecule 1 mg —

Indications

No indication recorded.