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Posted by on Feb 28, 2019 in Parkinson's Disease | 0 comments

In a nutshell

This study investigated the effectiveness and safety of CVT-301 (levodopa oral inhalation powder; Inbrija) for the treatment of patients with Parkinson's disease (PD). Researchers suggested that CVT-301 can improve the symptoms of patients with PD with manageable side effects.

Some background

The standard treatment for PD is levodopa. Initial treatment provides benefits lasting beyond 2 hours. However, after 2 years or more of treatment, the duration of the response to this agent shortens. This is mostly because of a delayed function of the digestive system. Therefore, symptom relief from each dose becomes unpredictable, with delayed effect or no effect at all. This affects the treatment of PD symptoms and the quality of life of the patients and their caregivers.

CVT-301 is taken by oral inhalation, bypassing the digestive system. Prior studies showed that this agent is associated with an improvement of symptoms and a reduced number of off periods. The role of CVT-301 in patients with PD with off periods remain under investigation.

Methods & findings

This study included information about 290 patients. These patients had daily off periods of 2h or longer. Patients were randomly assigned to receive CVT-301 60mg (96 patients), CVT-301 84 mg (97 patients), or placebo (97 patients).

After 12 weeks of treatment, patients treated with CVT-301 had significantly improved symptoms when compared to the placebo group.

Treatment was safe and with manageable side effects. Serious side effects were seen in 3 of the placebo patients, in 6 of the CVT 60 mg group, and 2 in the CVT 84 mg group. Low blood pressure and abnormal heart rhythm were related to the drug.

The bottom line

This study concluded that CVT-301 is an effective treatment option for patients with PD and off periods, with manageable side effects.

The fine print

This study only lasted for 12 weeks. Longer-term studies are needed. This study received support from Acorda Therapeutics, Inc, the manufacturer of CVT-301.

Published By :

The Lancet. Neurology

Date :

Feb 01, 2019

Original Title :

Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson’s disease: a randomised, double-blind, placebo-controlled phase 3 trial.

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