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VBCN - July 2015 Volume 2, No 2 - Parkinson’s Disease
Chase Doyle

San Diego, CA—An inhaled formulation of levodopa (CVT-301) eased breakthrough motor symptoms in patients with Parkinson’s disease (PD) between standard levodopa doses in a phase 2 clinical trial. According to data presented at the International Congress of Parkinson’s Disease and Movement Disorders, patients using the inhaled formulation were better able to bridge Parkinson’s “off” periods when their oral therapy had abated.

“During 4 weeks of use, inhaled levodopa provides rapid motor improvement in Parkinson’s ‘off’ states and reduces daily ‘off’ time without worsening time ‘on’ with dyskinesia,” said Robert A. Hauser, MD, MBA, Director of Parkinson’s Disease and Movement Disorders Center, University of South Florida, Tampa.

Although oral levodopa remains the most effective treatment for PD symptoms, irregularity in intestinal absorption diminishes the drug’s ability to provide consistent motor improvements in patients experiencing “off” states, Dr Hauser reported. Motor fluctuations oscillate between these “off” times, a state of decreased mobility, and “on” times, or periods when the medication is working and symptoms are controlled.

“Approximately two-thirds of patients will experience these ‘off’ states within 10 years of onset,” Dr Hauser told Value-Based Care in Neurology, “which means that their normal levodopa medication wears off before the next dose, and they get a return of symptoms potentially, including slowness, stiffness, tremor, and decreased mobility.”

Although these episodes can be treated to some extent with more frequent oral medication, problems occur when the dosage exceeds 4 times daily.

“It may take a longer time for oral levodopa to start to have an effect, and the duration of the effect may become more variable from dose to dose,” said Dr Hauser. “If oral levodopa is only lasting 2.5 to 3 hours, it’s very difficult for patients to plan their lives. They can only really function 3 hours at a time.”

Researchers randomized 86 patients with PD during a 4-week period to receive inhaled levodopa or placebo. All patients received oral levodopa therapy (mean intake, 770 mg daily), with an average “off” time of 5.9 hours daily. For the first 2 weeks, patients received a 35-mg dose, which increased to a 50-mg dose for the last 2 weeks.

The first component of the study was the in-office evaluation of inhaled levodopa versus placebo. Patients waited until their morning levodopa oral dose started to wane, at which point they inhaled levodopa or the placebo. They were then evaluated at 10-minute intervals for 60 minutes using PD motor scores.

“Beginning at 10 minutes, there was separation from placebo, and that improvement persisted throughout the observation of 60 minutes,” said Dr Hauser. “So at every interval from 10 minutes to 60 minutes, both 35 mg and 50 mg provided better motor improvement than placebo.”

For the second part of the study, patients were given an inhaler that contained levodopa or placebo for use at home up to 3 times daily. Daily “off” and “on” times were evaluated with data from the patients’ diaries.

On average, patients used the “rescue” levodopa or placebo 2 times daily. “Patients reported reductions in ‘off’ time of 1.1 hours per day with the 35-mg dose,” Dr Hauser noted, “and a significant 1.6 hours per day with the 50-mg dose.”

Although there was not a significant increase in dyskinesia, patients in the active drug group did experience more adverse events, 47% versus 33%, including dizziness, cough, nausea, and anxiety, he reported.

“Patients who experience these ‘off’ episodes have a decreased quality of life. It becomes very disruptive and makes it difficult to function throughout the day. So, clearly there’s a need for better interventions,” he concluded.

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Last modified: August 5, 2015
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