Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Merck Serono Begins Phase III Parkinson's Study | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

Merck Serono Begins Phase III Parkinson’s Study

Merck Serono and partner Newron Pharmaceuticals SpA have initiated the SETTLE study to evaluate the efficacy and safety of a dose range of safinamide (50-100 mg once daily) as an add-on therapy to levodopa, in mid- to late-stage Parkinson's disease patien

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck Serono and partner Newron Pharmaceuticals SpA have initiated the SETTLE study to evaluate the efficacy and safety of a dose range of safinamide (50-100 mg once daily) as an add-on therapy to levodopa, in mid- to late-stage Parkinson’s disease patients.

The SETTLE study is one of the Phase III trials for a development program designed to support an application for marketing authorization. SETTLE is a six-month, randomized, double-blind, placebo-controlled trial that includes more than 450 patients with Parkinson’s disease treated with levodopa for at least four weeks whose motor fluctuations have more than one and a half hours of “OFF” time during the day. After a four-week levodopa dosage stabilization phase, study participants will be randomized in one of the two arms of the trial to receive either safinamide or placebo, as adjunctive treatment to levodopa therapy.

The primary endpoint is the change in daily “ON” time, as assessed by patient diaries, from baseline to week 24. Secondary endpoints include changes in measures of activities of daily living, global clinical status and health-related quality of life.

“Managing motor fluctuations and reducing the time during which anti-Parkinson drugs are not working and symptoms return, the so-called ‘OFF’ times, are still unmet medical needs for patients with mid- to late-stage Parkinson’s disease,” said Bernhard Kirschbaum, Merck Serono’s head of Global R&D. “After the encouraging results we obtained for study 016, we aim to confirm the efficacy of safinamide as an add-on therapy to levodopa in a flexible dosing regimen.”

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters