CVT-301 significantly improves movement in Parkinson’s disease patients at times of the day when the impact of other therapies diminishes, according to a Phase 3 clinical trial.
The impact of a Parkinson’s treatment varies during the day. It is often most effective right after a patient takes it, and least effective when much of its punch has worn off hours later. But its effectiveness can vary between those periods as well.
The time when a therapy is doing a good job of controlling Parkinson’s movement symptoms is called an on period, and the time when the symptoms re-emerge an off period.
Acorda Therapeutics developed CVT-301, or levodopa inhalation powder, to address Parkinson’s patients’ movement problems during off periods.
The company presented the results of the SPAN-PD Phase 3 clinical trial at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Vancouver, June 4-8. The poster session was titled “Inhaled levodopa (CVT-301, 84-mg dose) significantly improves motor function during OFF periods in Parkinson’s disease subjects: A Phase 3 Study (SPAN-PD).”
CVT-301 is designed to reduce off-period movement problems of Parkinson’s patients who are taking a combination of levodopa and carbidopa for those symptoms.
SPAN-PD (NCT02240030) was a 12-week, placebo-controlled study that recruited 339 Parkinson’s patients experiencing off periods. The participants were randomized to receive one of two oral doses of CVT-301 — 84 mg or 60 mg — or a placebo. They could take the therapy up to five times a day during off episodes.
The primary goal of the trial was to see if CTV-301 would lead to patients experiencing better movement function during off periods than the control group. At week 12, those who took the 84-mg dose of CVT-301 showed significant movement improvement, compared with the placebo group.
Researchers used the Unified Parkinson’s Disease Rating Scale-Part 3 to evaluate improvement in movement. They conducted the test 30 minutes after a patient took CTV-301 or the placebo.
CTV-301 achieved secondary trial goals as well. One was the therapy’s ability to take a patient from an off state to an on state and maintain the on state for at least an hour. Another was to improve treated patients’ scores in a measure of movement function change, known as the Patient Global Impression of Change.
Several adverse events were observed in the group that took 84 mg of CVT-301, compared with the placebo group. An example was that 15 percent of CVT-301 patients experienced coughing, versus less than 2 percent of the control group.
The Phase 3 trial followed up a Phase 2b trial that also showed CVT-301 was effective.
Acorda also presented results from another Phase 3 clinical trial that evaluated CVT-301’s impact on lung function. The ongoing, long-term CVT-301-005 study (NCT02352363) compared 84 mg of CVT-301 with standard of care treatment.
Participants were randomized in a 2:1 ratio to receive either CVT-301 or a placebo. The treatment group included 271 patients, and the control group 127. Both groups were followed for 52 weeks.
The primary goal of the study was to see whether CVT-301 could improve patients’ scores on two lung-function measures. One was a measure known as Forced Expiratory Volume in 1 second, or FEV1. The other was a measure of the lungs’ ability to rid themselves of carbon monoxide.
At week 52, the pulmonary function of the two groups was not statistically different, researchers said.
The study also included safety measurements that were conducted only in the CVT-301 arm. It showed that at week 52, 85 percent of participants were able to achieve an on state lasting more than an hour after taking CVT-301. And three-quarters reported improvements in their movement function.
Acorda is planning to submit a new drug application to the U.S. Food and Drug Administration before the third quarter of 2017, and a marketing authorization application to the European Medicines Agency by the end of the year. The applications will cover CVT-301 as a treatment for Parkinson’s patients experiencing off periods.