Safinamide added to L-Dopa improves wearing-off symptoms in patients with Parkinson’s disease

This study investigated the effectiveness and safety of safinamide (Xadago) in patients with Parkinson's disease (PD) and wearing-OFF symptoms. Researchers suggested that safinamide improved OFF symptoms in these patients.

PD is a chronic disease that affects the brain. Over time, brain cells lose their abilities to control body functions. This causes symptoms such as muscle weakness and tremors. The standard treatment for PD is levodopa. However, long-term use of this drug is associated with side effects such as wearing-off symptoms. Wearing-off periods consist of the come back of PD symptoms in between levodopa doses, sometimes worse.

Prior studies suggested that safinamide is associated with improved OFF symptoms in PD patients. However, the adequate dose of safinamide to use in these patients is still not clear.

This study included information about 349 PD patients. These patients were on levodopa treatment and had OFF symptoms. Participants were assigned to receive a placebo (Group P; drug with no effect on the body), safinamide 50 mg/day (Group S50), or safinamide 100 mg/day (Group S100). The average daily ON-time was assessed during a follow-up period of 24 weeks.

At 24 weeks, when compared to the placebo group the ON-time in the S50 group increased by 1.39 hours. In the S100 group increased 1.66 hours. PD symptoms significantly improved at 24 weeks compared to the placebo group.

Negative side effects were reported in 58.9% in the P group. This was compared to 60.2% of patients in the S50 group and 61.4% on the S100 group. The most common side effects were dyskinesias (involuntary random movement of the face, arms, or legs) reported in 2.1% in group P, 8.3% in group S50, and 10.6% in group S100. Visual hallucinations were another side effect reported in 1.4% of group P, 3% in group S50, and 4.5% on group S100.

This study concluded that safinamide 100 mg/day is a safe and effective addition to levodopa to treat PD patients with wearing-off symptoms.

This study was funded by Meiji Seika Pharma Co., Ltd, the safinamide manufacturer.