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CHICAGO – The investigational agent pimavanserin appears to lessen the symptoms of psychosis in patients with Parkinson's disease without worsening motor function, according to data from a multicenter randomized phase II trial involving 60 patients.
Pimavanserin is a potent, active 5-hydroxytryptamine 2a (5-HT2a) serotonin receptor antagonist, according to Dr. Revell of Acadia Pharmaceuticals Inc., which sponsored the study. However, it lacks the dopamine receptor (D2) and histamine receptor (H1) binding that are linked to intolerable adverse effects of other antipsychotics. Pimavanserin is being developed as a cotherapy for schizophrenia, as well as for Parkinson's disease psychosis.
Patients in the study had Parkinson's disease and psychosis and received either pimavanserin (n = 29) or placebo (n = 31) on an outpatient basis for 28 days, starting at 20 mg daily on day 1, with dose escalations to 40 mg and 60 mg on day 8 and 15, respectively, depending on individual clinical response.
Patients treated with pimavanserin demonstrated a 40% improvement in the Scale for the Assessment of Positive Symptoms (SAPS) combination score for hallucination and delusion, as compared with an 11% improvement for patients treated with placebo, Dr. Stephen Revell and associates reported in a poster at the 12th International Congress of Parkinson's Disease and Movement Disorders.
Statistically significant improvements also were observed for patients treated with pimavanserin on the mentation, behavior, and mood part of the Unified Parkinson's Disease Rating Scale (UPDRS).
There was no clinically significant difference between patients treated with placebo vs. pimavanserin in absolute mean change from baseline to day 28 in UPDRS motor scores (−3.05 vs. −1.24) or activities of daily living scores (−2.51 vs. −0.70).
No differences were observed between groups on the Schwab and England Activities of Daily Living Scale part of the UPDRS or the Clinical Global Impression Scale severity of illness subscale.
The most common adverse events in patients treated with pimavanserin were somnolence, edema, and increased blood urea–each occurring in three patients, the authors wrote.
In a second poster presented at the meeting, pimavanserin was well tolerated and did not worsen Parkinsonism symptoms in 39 patients (mean age 72 years) with Parkinson's and psychosis at doses up to 60 mg/day for up to 42 months (mean 14 months). Adverse events commonly experienced with clozapine and quetiapine–such as somnolence, fatigue, and dizziness–were uncommon with pimavanserin, according to Dr. Roger Mills, also of Acadia, who led the industry-sponsored, open-label extension safety study.
Only one patient who experienced somnolence discontinued pimavanserin treatment. A single case of rhabdomyolysis was the only serious adverse event considered to be possibly treatment-related.
ELSEVIER GLOBAL MEDICAL NEWS
CHICAGO – The investigational agent pimavanserin appears to lessen the symptoms of psychosis in patients with Parkinson's disease without worsening motor function, according to data from a multicenter randomized phase II trial involving 60 patients.
Pimavanserin is a potent, active 5-hydroxytryptamine 2a (5-HT2a) serotonin receptor antagonist, according to Dr. Revell of Acadia Pharmaceuticals Inc., which sponsored the study. However, it lacks the dopamine receptor (D2) and histamine receptor (H1) binding that are linked to intolerable adverse effects of other antipsychotics. Pimavanserin is being developed as a cotherapy for schizophrenia, as well as for Parkinson's disease psychosis.
Patients in the study had Parkinson's disease and psychosis and received either pimavanserin (n = 29) or placebo (n = 31) on an outpatient basis for 28 days, starting at 20 mg daily on day 1, with dose escalations to 40 mg and 60 mg on day 8 and 15, respectively, depending on individual clinical response.
Patients treated with pimavanserin demonstrated a 40% improvement in the Scale for the Assessment of Positive Symptoms (SAPS) combination score for hallucination and delusion, as compared with an 11% improvement for patients treated with placebo, Dr. Stephen Revell and associates reported in a poster at the 12th International Congress of Parkinson's Disease and Movement Disorders.
Statistically significant improvements also were observed for patients treated with pimavanserin on the mentation, behavior, and mood part of the Unified Parkinson's Disease Rating Scale (UPDRS).
There was no clinically significant difference between patients treated with placebo vs. pimavanserin in absolute mean change from baseline to day 28 in UPDRS motor scores (−3.05 vs. −1.24) or activities of daily living scores (−2.51 vs. −0.70).
No differences were observed between groups on the Schwab and England Activities of Daily Living Scale part of the UPDRS or the Clinical Global Impression Scale severity of illness subscale.
The most common adverse events in patients treated with pimavanserin were somnolence, edema, and increased blood urea–each occurring in three patients, the authors wrote.
In a second poster presented at the meeting, pimavanserin was well tolerated and did not worsen Parkinsonism symptoms in 39 patients (mean age 72 years) with Parkinson's and psychosis at doses up to 60 mg/day for up to 42 months (mean 14 months). Adverse events commonly experienced with clozapine and quetiapine–such as somnolence, fatigue, and dizziness–were uncommon with pimavanserin, according to Dr. Roger Mills, also of Acadia, who led the industry-sponsored, open-label extension safety study.
Only one patient who experienced somnolence discontinued pimavanserin treatment. A single case of rhabdomyolysis was the only serious adverse event considered to be possibly treatment-related.
ELSEVIER GLOBAL MEDICAL NEWS
CHICAGO – The investigational agent pimavanserin appears to lessen the symptoms of psychosis in patients with Parkinson's disease without worsening motor function, according to data from a multicenter randomized phase II trial involving 60 patients.
Pimavanserin is a potent, active 5-hydroxytryptamine 2a (5-HT2a) serotonin receptor antagonist, according to Dr. Revell of Acadia Pharmaceuticals Inc., which sponsored the study. However, it lacks the dopamine receptor (D2) and histamine receptor (H1) binding that are linked to intolerable adverse effects of other antipsychotics. Pimavanserin is being developed as a cotherapy for schizophrenia, as well as for Parkinson's disease psychosis.
Patients in the study had Parkinson's disease and psychosis and received either pimavanserin (n = 29) or placebo (n = 31) on an outpatient basis for 28 days, starting at 20 mg daily on day 1, with dose escalations to 40 mg and 60 mg on day 8 and 15, respectively, depending on individual clinical response.
Patients treated with pimavanserin demonstrated a 40% improvement in the Scale for the Assessment of Positive Symptoms (SAPS) combination score for hallucination and delusion, as compared with an 11% improvement for patients treated with placebo, Dr. Stephen Revell and associates reported in a poster at the 12th International Congress of Parkinson's Disease and Movement Disorders.
Statistically significant improvements also were observed for patients treated with pimavanserin on the mentation, behavior, and mood part of the Unified Parkinson's Disease Rating Scale (UPDRS).
There was no clinically significant difference between patients treated with placebo vs. pimavanserin in absolute mean change from baseline to day 28 in UPDRS motor scores (−3.05 vs. −1.24) or activities of daily living scores (−2.51 vs. −0.70).
No differences were observed between groups on the Schwab and England Activities of Daily Living Scale part of the UPDRS or the Clinical Global Impression Scale severity of illness subscale.
The most common adverse events in patients treated with pimavanserin were somnolence, edema, and increased blood urea–each occurring in three patients, the authors wrote.
In a second poster presented at the meeting, pimavanserin was well tolerated and did not worsen Parkinsonism symptoms in 39 patients (mean age 72 years) with Parkinson's and psychosis at doses up to 60 mg/day for up to 42 months (mean 14 months). Adverse events commonly experienced with clozapine and quetiapine–such as somnolence, fatigue, and dizziness–were uncommon with pimavanserin, according to Dr. Roger Mills, also of Acadia, who led the industry-sponsored, open-label extension safety study.
Only one patient who experienced somnolence discontinued pimavanserin treatment. A single case of rhabdomyolysis was the only serious adverse event considered to be possibly treatment-related.
ELSEVIER GLOBAL MEDICAL NEWS