Date: 2011-01-20
Type of information:
phase: 3
Announcement: initiation
Company: Lundbeck (Denmark)
Product: zicronapine (Lu 31-130)
Action
mechanism: Zicronapine (formerly known as Lu 31-130) is a new type of compound with a strong pro-cognitive effect in animal models and the potential to treat a number of neurological and psychiatric diseases.
Disease: schizophrenia
Therapeutic area: Mental diseases - CNS diseases
Country: Europe
Trial
details: The first study in the clinical phase III programme is expected to enrol some 160 patients with the aim to measure the efficacy of zicronapine and risperidoneand their relative impact on key metabolic parameters. Long term relative safety and efficacy is a key factor in determining appropriate use of newer antipsychotics. Treatment duration is six months. The patients will be randomly assigned to zicronapine (7.5 mg/day) or risperidone (5 mg/day) treatment in a 1:1 ratio. The study is expected to enrol patients in several countries in Europe. Classical short term efficacy studies will be initiated in due time.
Latest
news: Lundbeck has announced the advancement of zicronapine into clinical phase III based on the positive clinical phase II data. The pivotal program is planned to include further phase III studies to investigate the compound's benefit and risk profile.
