Long-term safety, tolerability and efficacy of apomorphine sublingual film in patients with Parkinson's disease complicated by OFF episodes: a phase 3, open-label study.

ABSTRACT:

Background

Apomorphine sublingual film (SL-APO) is an on-demand treatment for OFF episodes in patients with Parkinson's disease (PD).

Objective

To assess the long-term (≥ 3 years) safety/tolerability and efficacy of SL-APO.

Methods

Study CTH-301 ( http://www.

Clinicaltrials

gov NCT02542696; registered 2015-09-03) was a phase 3, multicentre, open-label study of SL-APO in PD patients with motor fluctuations, comprised of a dose-titration and long-term safety phase. All participants received SL-APO. The primary endpoint was safety/tolerability (treatment-emergent adverse events [TEAEs]) during the long-term safety phase. Efficacy assessments included the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor examination), as

SUBMITTER: Kassubek J 

PROVIDER: S-EPMC11136727 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature