Clinical Trials

Date: 2015-01-22

Type of information: Results

phase: 3b

Announcement: results

Company: Gedeon Richter (Hungary) Actavis (Ireland)

Product: cariprazine

Action mechanism:

• dopamine D3 receptor partial agonist. Cariprazine has been discovered by researchers at Gedeon Richter. This orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2700 patients. In addition, cariprazine is being investigated for the treatment of bipolar depression and adjunctive MDD in adults. Cariprazine was discovered and co-developed by Gedeon Richter Plc and is licensed to Actavis, now Allergan, in the U.S. and Canada.

Disease: adult schizophrenia patients with persistent and predominant negative symptoms

Therapeutic area: CNS diseases - Mental diseases

Country:

Trial details:

• This Phase IIIb Study was a 26-week long, multinational, multicenter, randomized, double-blind, risperidone-controlled, parallel-group, fixed/flexible dose clinical trial to evaluate the efficacy, safety, and tolerability of cariprazine as monotherapy in adult patients suffering from schizophrenia with persistent and predominant negative symptoms. The patients' positive symptoms were stabilized at a low level and they did not have depressive symptoms. Patients were diagnosed with schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, had a minimum score of 24 on the PANSS-NFS, a maximum score of 19 points on the PANSS Factor Score for Positive Symptoms (PANSS-PFS), and no more than 6 points on the Calgary Depression Scale for Schizophrenia (CDSS).  Following a prospective lead-in period of 4 weeks, a total of 461 patients between 18 and 65 years of age were randomized to either cariprazine (N=230), or risperidone (N=231). Treatment was administered once daily for 26 weeks, followed by a 2-week safety follow-up period. The target doses for cariprazine and risperidone were 4.5 mg/day and 4.0 mg/day, respectively. The primary endpoint was defined as change from baseline in the PANSS-NFS at week 26, using a mixed-effects model for repeated measures (MMRM) analysis.
• The key secondary endpoint was change from baseline in PSP score at week 26, using an MMRM analysis. Cariprazine 4.5 mg/day also showed statistically significant improvement in the PSP score versus risperidone (+4.61; p<0.001).

Latest news:

• • On January 22, 2015, Gedeon Richter  announced positive top-line results from a Phase IIIb trial evaluating the efficacy, safety and tolerability of cariprazine, in adult schizophrenia patients with persistent and predominant negative symptoms. The cariprazine treatment group showed statistically significant improvement in the primary outcome measure, the Positive and Negative Syndromes Scale Factor Score for Negative Symptoms (PANSS-NFS) compared to risperidone. The cariprazine treatment group also showed statistically significant improvement with regard to the secondary outcome measure, the Personal and Social Performance Scale (PSP) compared to risperidone. The patients tolerated the treatment well. A total of 77.4% of the patients in each of the treatment groups completed the 26 week treatment period. The cariprazine treatment group showed statistically significant improvement in the PANSS-NFS relative to risperidone at week 26 (-1.47; p=0.002). The key secondary endpoint was change from baseline in PSP score at week 26, using an MMRM analysis. Cariprazine 4.5 mg/day also showed statistically significant improvement in the PSP score versus risperidone (+4.61; p<0.001). No treatment emergent adverse event was reported in more than 10% of the patients. The most frequent adverse events (incidence ?5%) across both treatments groups were insomnia, headache, akathisia, worsening of schizophrenia symptoms, anxiety and somnolence. Data will be further analyzed in the coming weeks.

 

Is general: Yes