Research in Movement Disorders

A Phase IIIb, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dysport Using 2 mL Dilution in Adults with Cervical Dystonia (A-TL-52120-169)

[Study Sponsor: Ipsen Biopharmaceuticals, Inc.; Principal Investigator: Scott Sherman, MD, PhD]

The primary objective of this study is to evaluate the efficacy of Dysport 500 units (U)/vial using 2 mL dilution compared with placebo for the treatment of cervical dystonia (CD).

In this study, the treatment dose of Dysport is between 250 U and 500 U. All participants are planned to have a single treatment in this study. Duration will be between 4 and 16 weeks. Participants will be randomized in a ratio of 2:1. The randomization will be stratified according to whether the participant is botulinum toxin (BTX) treatment naïve or has been successfully treated with Botox based on Investigator judgment.

All participants who complete the Week 12 study visit will be offered entry into an open-label extension (OLE) study which consists of up to 3 treatment cycles of Dysport using the 2 mL dilution scheme. Participants will also be compensated for their time and travel.

You may be eligible to participate if you:

  • Are 18 years of age or older
  • Have a history and primary diagnosis of CD of at least 18 months since onset
  • Have previously not been treated with BTX or are currently being treated with BTX

A Phase III, 12-week, Double-blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease (KW-6002-014)

[Study Sponsor: Kyowa Hakko Kirin Pharma, Inc.; Principal Investigator: Scott Sherman, MD, PhD]

The primary objective of this study is to establish the efficacy of Istradefylline 20 and 40 mg/day for reducing the total hours per day of OFF time in patients with moderate to severe Parkinson's Disease (PD) with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or benserazide/levodopa) therapy.

Participants will undergo screening and baseline evaluations for eligibility for the study. Eligible participants will be randomized to treatment with study drug or placebo. Following randomization to double-blind treatment, subjects will be evaluated for efficacy by at least one valid 24-hour ON/OFF patient diary, the Unified Parkinson's Disease Rating Scale (UPDRS), and the Patient Global Impression - Improvement Scale (PGI-I).

Participants will receive, at no charge, the investigational drug, physical and neurological exams, clinical laboratory services, 12-lead electrocardiograms (ECG) and medical monitoring by a nurse and physician. Participants will also be compensated for their time and travel.

You may be eligible to participate if you:

  • Are 30 years of age or older
  • Have a primary diagnosis of Parkinson's Disease
  • Have previously been treated with levodopa therapy for at least 1 year
  • Are experiencing significant motor fluctuations while receiving levodopa combination therapy plus adjunctive medication(s)
  • Are willing to undergo diary training and accurately complete an ON/OFF patient diary throughout the study

If you are interested in seeing if someone you know is eligible to participate in any of these studies or if you just want more information, please contact:

Susan Merski, BSN, RN
Research Nurse, Sr.
(520) 626-4296

University of Arizona, Health Science Center, Department of Neurology
1501 N. Campbell Avenue, Room 7329
Tucson, AZ 85724-5023
Fax: 520-626-4903