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News from the MDS International Congress
Inhaled Levodopa Quickly Abolishes ‘Off Time’ Symptoms for Parkinson's Patients

ARTICLE IN BRIEF

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DR. ROBERT A. HAUSER: “During up to one month of continued use, CVT-301 was safe and well-tolerated. The at-home treatment with CVT-301 50 mg led to a significant reduction in off time, despite the limitation of patients only being able to use the treatment up to three times a day.”

In a four-week phase 2 study, Parkinson's disease patients who took an inhaled formulation of levodopa called CVT-301 experienced a significant reduction in motor symptoms in as little as 10 minutes when compared with placebo patients. The study was presented at the International Congress of Parkinson's Disease and Movement Disorders in June.

SAN DIEGO—An inhaled formulation of levodopa called CVT-301 appears to rapidly improve motor movement in Parkinson's disease patients whose symptoms return during the so-called “off times” when the medication is not working, researchers reported here in June at the International Congress of Parkinson's Disease and Movement Disorders.

In the four-week phase 2 study, patients who took the inhaled product experienced a significant reduction in motor symptoms in as little as 10 minutes when compared with placebo patients, Robert A. Hauser, MD, FAAN, director of the Parkinson's Disease and Movement Disorders Center at the University of South Florida in Tampa, told Neurology Today.

STUDY METHODOLOGY, RESULTS

In the study, Dr. Hauser and colleagues randomized 86 patients — mostly men, aged 60 years old, who had been diagnosed for nine years — to either 35 mg placebo capsules or CVT-301 for two weeks, and then to 50 mg capsules for two weeks. Patients were instructed to use the inhaled agent as needed when symptoms occurred between levodopa doses.

The researchers reported that when the patients used CVT-301, their scores on the United Parkinson's Disease Rating Scale (UPDRS) dropped by about 5 points at 10 minutes compared with 2 points among placebo patients (p<0.05), and at 20 minutes the reduction was 10 points compared to 3.1 points among the placebo patients (p<0.05), Dr. Hauser said.

[The UPDRS scale assesses both motor and nonmotor functioning and complications in daily living activities on several scales of 0-4, where 0 is normal and 4 is severe. A decline in scores reflects less severe disability.]

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DR. MARK F. LEW said that the findings are from a phase 2 study so they will have to be confirmed in a larger and longer trial. But, he said, “this is an exciting development that may benefit patients with Parkinsons disease symptoms during their off time.”

Patients were able to prepare and self-administer the medication in about 30 seconds, Dr. Hauser noted. Overall, CVT-301 was associated with a 1.6-hour reduction in daily off time, or a 30- to 35-percent reduction from baseline during the period of use. In addition, no increase in “on time” with dyskinesia was evident, he pointed out.

“During up to one month of continued use, CVT-301 was safe and well-tolerated,” Dr. Hauser said. “The at-home treatment with CVT-301 50 mg led to a significant reduction in off time, despite the limitation of patients only being able to use the treatment up to three times a day.”

Dr. Hauser noted that the effectiveness of the inhaled levodopa appeared to continue for at least 60 minutes, usually the time required for oral levodopa doses to begin to work in these patients.

EXPERT COMMENTARY

“This is a phase 2 study,” so the findings will have to be confirmed in a larger and longer trial, noted Mark F. Lew, MD, FAAN, a professor of neurology and director of the Division of Movement Disorders at the Keck Medical Center of the University of Southern California, Los Angeles, who was not involved with the study. “But this is an exciting development that may benefit patients with Parkinson's disease symptoms during their off time.”

Peter Jenner, PhD, BPharm, a professor of pharmacology and therapeutics at King's College London, added: “This work is important as it appears to offer a further and novel route of administration of levodopa that can be used to treat off periods. My immediate thought is that it will offer an alternative to rescue from ‘off’ periods currently achieved by subcutaneous injection of apomorphine.”

“A non-invasive form of rescue therapy will have utility and convenience for patients with Parkinson's disease experiencing sudden off time, and will improve their quality of life,” he concluded.

The trial was sponsored by Civitas, which has subsequently become part of Acorda Therapeutics in Chelsea, MA.

LINK UP FOR MORE INFORMATION:

•. MDS International Congress Abstract: Inhaled levodopa (CVT-301) provides rapid motor improvements after administration to Parkinson's disease patients when OFF: http://bit.ly/MDS-inhaledlevodopa
    •. More coverage from the MDS Neurology Today Conference Reporter: http://bit.ly/NTCR-MDS