CVT-301 Treatment Associated With Improvements in Motor Scores, Daily Living in Patients With Parkinson Disease

May 12, 2020

Improvements observed through CVT-301 treatment in motor scores measured by part 3 of the Unified Parkinson Disease Rating Scale were associated with improved scores in activities of daily living for patients with Parkinson disease, according to findings presented in an abstract.

Improvements observed through CVT-301 treatment in motor scores measured by part 3 of the Unified Parkinson Disease Rating Scale (UPDRS-III) were associated with improved scores in activities of daily living (ADL) for patients with Parkinson disease (PD), according to findings presented in an abstract at the Pan American Parkinson Disease and Movement Disorders Congress in Miami, Florida.

CVT-301 (84 mg), an inhaled formulation of levodopa sold as Inbrija, was shown in the SPAN-PD study to significantly improve motor function in patients with PD (PwP) experiencing OFF periods at week 12, as measured by lower UPDRS-III scores. Moreover, the study showed that 58% of patients achieved and maintained an ON state more than than 60 minutes after a CVT-301 dose compared with 36% of those on placebo (P = .003), and 71.4% reported improvement in Patient Global Impression of Change (PGIC) compared with 46.4% on placebo (nominal P <.001).

In a post hoc analysis, ADL subdomain scores in the Parkinson Disease Questionnaire (PDQ-39) were shown to correlate with PGIC scores, in which PDQ-39 ADL scores decreased (improved) as PGIC was more positive. While the correlation was not statistically significant, researchers note that the PDQ-39 ADL treatment difference (84mg vs placebo) of —2.08 surpassed the desired threshold of –1.98 units.

Researchers sought to extend research on whether improvements in UPDRS-III motor scores from CVT-301 treatment correlated with ADL scores. The study examined PwP experiencing OFF periods on an oral carbidopa/levodopa regimen, who were randomized to receive placebo or CVT-301 (60 mg or 84 mg) for the treatment of OFF period symptoms as needed up to 5 times per day. PDQ-39 and UPDRS-III were completed at baseline and at 4, 8, and 12 weeks.

At week 12, study findings showed that UPDRS-III improvements at 30 minutes post dose were associated with a mean improvement of —3.43 points in PDQ-39 ADL subdomain score, which exceeded the –1.98 threshold. In PwP reporting worsening or no change in UPDRS-III scores at 30 minutes post dose, PDQ-39 ADL scores were also affected as shown by a +1.33 worsening. Conversely, those reporting a 30% or greater UPDRS-III improvement were associated with an improvement of –4.42 points in PDQ-39 ADL scores.

“Responder ON patients showed greater improvements in PDQ-39 ADL (—4.05) than nonresponders (–0.82),” said the researchers.

As OFF periods in PwP has been shown in prior studies to impede work productivity and employment of patients, as well as cause greater financial impact for caregivers, potential improvements through CVT-301 treatment may assist in controlling symptom burden based on study findings.

Reference

Hauser R, Klingler M, Abeynayake I, et al. Improvement in UPDRS motor scores after CVT-301 treatment is associated with improved scores in the Parkinson's Disease Questionnaire activities of daily living. Presented at: Pan American Parkinson Disease and Movement Disorders Congress; February 14-16, 2020; Miami, FL. Abstract LBA 9.