Learn how we achieved all milestones on time and within the study parameters of a Phase I Parkinson's Disease study.

1. Case Study
Meeting Milestones and Delivering
Successful Outcomes for a Phase I
Parkinson’s Disease Study
Covance has recently completed full-service execution of a Phase I multiple ascending dose (MAD)
study in Parkinson’s disease (PD) patients. This case study presented a typical set of challenges
encountered when executing PD studies, as well as unique challenges pertaining to the specifics of the
protocol. Our successful execution culminated from the outstanding performance of a high-performing
expert team, along with tested processes and tactics that were put in place to offer appropriate solutions
to the many challenges that were encountered. Additionally, our team was able to build and nurture strong
relationships with top-tier sites, which not only have the correct set of capabilities and appropriate patient
population and recruitment expectations, but were also able to accommodate and deliver on all procedures
required of such a demanding MAD study.
Study Population
Adult patients with PD currently on mono- or multiple therapies, with Hoehn and Yahr stage ≤3 and UPDRS
Part III ≥ 10 but ≤ 30, who were recruited to jointly receive an injectable therapeutic in a dose escalating study of
several cohorts of short duration, and undergo serial pharmacokinetic assessments, along with designated safety
and efficacy outcomes.
Situation
A key component was to identify experienced and motivated sites and investigators with a large population of
appropriate PD patients. The study allowed concomitant use of anti-PD therapies except for medications with
potential impact upon dopamine function.
Challenges
The study required Covance to identify appropriate investigators who could identify and motivate the appropriate
patient population to enroll in a relatively demanding protocol. Although many study centers had clinical trial
experience in this indication it was critical to ascertain availability of centers with a large PD patient population
that can meet the entry criteria and an established referral program. In addition to the challenge of identifying
and motivating previously diagnosed patients on multi-therapies, it was critical that sites also possess the ability to
motivate newly diagnosed PD patients to enroll into a clinical trial and forgo the use of treatments with potential
effect on the dopamine system.

2. Action Plan
▶ Early engagement with sponsor to gain full understanding of protocol design and impact of
prohibited medications upon both the patient population and site recruitment.
▶ Utilized Covance Xcellerate®
methodology and central nervous system (CNS) site network to identify
sites that have conducted PD studies successfully.
▶ Priority sites were identified based upon past Covance and sponsor experience and were ranked
primarily based upon the established patient population, the access to outside referrals, and adequate
professional staff.
▶ Fully disclosed feasibility assessment followed by site qualification visits conducted by the extended
Covance team.
▶ Clear, transparent, and proactive communication between all team members, including the medical
team, the site staff and all monitors regarding all entry criteria, such as close attention to the list of
prohibited medications.
▶ Prescreening directives provided to reduce screen failures.
Successful Outcomes
▶ Covance successfully met set expectations and achieved all milestones of activating sites.
▶ Covance successfully met recruitment milestones of all patients into several successive cohorts that
progressed following favorable adjudication by a data monitoring committee.
▶ Successfully identified appropriate number of high-performing sites with the necessary and adequate
patient population.
▶ Successful delivery of all assessments pertaining to safety, pharmacokinetics as well as efficacy
outcomes based upon UPDRS.
▶ Sponsor was overly appreciative of the performance and quality of communication, as well as
professional interactions with research sites.
▶ Successful completion of the final clinical study report leveraging strong expertise in data analysis
and reporting.
To learn more about how Covance can help you meet the challenges in developing neuroscience
therapies and delivering them to market quickly and cost effectively, please contact us at
www.covance.com/neuroscience.
Covance Inc., headquartered in Princeton, NJ, USA is the drug
development business of Laboratory Corporation of America Holdings
(LabCorp). COVANCE is a registered trademark and the marketing
name for Covance Inc. and its subsidiaries around the world.
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