EASED™ Study
 

What is the EASED™ study?

Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia

  • This study is evaluating the safety and effectiveness of an experimental drug (ADS-5102) for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson’s disease (PD).
  • ADS-5102 is an extended-release form of amantadine (already approved by FDA for treatment of PD) and is designed to be taken once daily at night, providing a slow release of the drug into the blood stream.
  • The purpose of this study is to understand what dose of the new drug works best for reducing LID. This study will compare the benefits and risks of 3 different doses compared to placebo (an inactive look alike).
  • ADS-5102 is experimental and is not approved for sale in the United States by the Food and Drug Administration (FDA).

Do you qualify for the EASED™ study?

  • Are you age 30-85? Do you have Parkinson’s disease?
  • Are you currently take antiparkinson’s medications, including a levodopa medication at least 3 times daily? (e.g. Stalevo®, Sinemet®)
  • Are you experiencing troublesome dyskinesia following your levodopa dosing?
  • You must also be able to understand and complete a standardized home diary, following training.
  • Other criteria will be reviewed during your first visit with the study staff.

What is dyskinesia?

  • Dyskinesia refers to the jerky, dance-like, involuntary movements that often occur after a dose of levodopa.
  • Dyskinesias commonly occur when the level of levodopa in your bloodstream is at its maximum, usually beginning 30 minutes after taking the medicine.
  • Dyskinesia is different from the tremor of Parkinson’s disease. Dyskinesias are larger non-purposeful movements involving several joints. These erratic movements can involve the arms, head and trunk.
  • Dyskinesia develops in many Parkinson’s disease patients, usually after 5 to 8 years of taking levodopa. This side effect can become severely disabling and has been associated with a decrease in the quality of life1.

What is troublesome dyskinesia?

“Troublesome dyskinesia interferes with function or causes meaningful discomfort”.2

As examples, due to your abnormal movements, do you:

  • Have difficulty eating?
  • Have trouble brushing your teeth?
  • Have difficulty reading the newspaper?

How long will the EASED™ study last?

  • Your participation in the study would last no more than 3 months (up to 3 weeks for screening, 8 weeks of taking the study drug, and 2 weeks of follow-up).
  • The study includes 8 office visits and one follow up phone call.

Is there other important information I should know about the EASED™ study?

  • This is a double-blind study: neither you nor the study staff will know what treatment you are receiving.
  • The study drug will be taken as 3 capsules each night for 8 weeks.
  • The study drugs (including placebo) will be identical in appearance and will be packaged in blister cards.
  • You will continue your current PD medications throughout the study.
  • You will complete one or more questionnaires about fatigue and quality of life during clinic visits.
  • You will also complete Home Diaries before certain visits (for 48 hour time periods), recording information about your sleep and daytime symptoms. You will be reminded when to do this.

Where can I find more information on the EASED™ study?


1 Encarnacion, E. V. and R. A. Hauser (2008). “Levodopa-induced dyskinesias in Parkinson’s disease: etiology, impact on quality of life, and treatments.” Eur Neurol 60(2): 57-66.

2 Hauser, R.A, et al.(2000) “A Home diary to Assess Functional Status in Patients with Parkinson’s Disease with Motor Fluctuations and Dyskinesia.” Clinical Neuropharmacology 23 (2): 75-81.

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