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news.Canada-based Highland Therapeutics' subsidiary Ironshore Pharmaceuticals has started dosing in the second of two pivotal trials of HLD-200, a next-generation formulation of methylphenidate for patients with attention-deficit/hyperactivity disorder (ADHD).
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HLD-200 uses Ironshore’s drug delivery platform, DELEXIS, to enable nighttime dosing of these patients.
The multicenter, double-blind, randomized, placebo-controlled, parallel group Phase III trial (AHEAD) is designed to evaluate the safety and efficacy of evening-dosed HLD-200 on Post-waking, early morning function in children aged six to 12 years with ADHD.
Around 140 pediatric patients will be enrolled in the trial at about 21 sites in the US.
The company noted that previous trials have shown that it may be possible to improve patient outcomes by dosing patients at night in order to improve functioning and achieve greater control over symptoms associated with ADHD from the time of awakening through to the evening hours the next day.
Top-line data from the AHEAD study is expected to be generated in early 2016.
Ironshore chief executive officer David Lickrish said: "The start of the second pivotal trial is an enormous milestone and a terrific accomplishment for everyone involved in this ground-breaking research. Few studies have attempted to assess behaviours and functioning in ADHD patients during the morning routine.
"The Before School Functioning Questionnaire, or BSFQ, which was developed by Dr Tim Wilens and Dr Paul Hammerness at Massachusetts General Hospital, provides physicians with a new tool for assessing patients during this critical time of day.
"We believe that as awareness grows, physicians will start making questions about the morning routine a routine question and adjust their treatment options accordingly."
Together with the other pivotal study that the company recently started, the current trial has been designed to build upon the successful results of the exploratory Phase III trial, known as Clinical Endpoint Evaluation Study (CEES), which was completed last year.