Study Of Amantadine Hcl Extended Release Capsules For The Treatment Of Levodopa Induced Dyskinesia
Posted Date: Apr 9, 2018
- Investigator: Alberto Espay
- Specialties: Parkinson's Disease, Neurology, Movement Disorders
- Type of Study: Drug
Amantadine, in an immediate-release (IR) formulation, is approved by the FDA for the treatment of Parkinson’s disease (PD). Neurologists sometimes also use amantadine to treat levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease, or involuntary movements involving the head, body, and limbs that typically occur after a dose of levodopa. This use of amantadine is considered “off-label”, meaning that the FDA has not approved the use of amantadine for the treatment of LID. Studies have been conducted using amantadine in the treatment of LID and the results are encouraging. However, the effectiveness of amantadine for the treatment of LID has not been established. ADS-5102 is an extended-release (ER) formulation of amantadine and is designed to be taken by mouth, once nightly at bedtime, providing a slow release of amantadine into the bloodstream. It is hoped that the low amount of drug in the bloodstream in the evening and overnight may reduce some side effects, including difficulty sleeping and vivid dreams, which can occur with use of immediate release amantadine (see Risks or Discomforts section below). The higher amount of drug in the bloodstream will occur during the morning and mid-day. ADS-5102 is an experimental treatment. “Experimental” means that the study drug is currently being tested and is not approved by the Food and Drug Administration (FDA), and that the safety of ADS-5102 in PD patients with LID and its effectiveness in treating LID have not been established.
You Are Being Asked To Participate In This Study Because You Have Parkinson’S Disease And Have Levodopa Induced Dyskinesia. Three Groups Of Lid Patients Are Potentially Eligible To Participate In This Study: • Group 1 Includes Patients Who Are Currently Participating In An Adamas-Sponsored Study Of The Effectiveness Of Ads-5102, And Who Will Enter Into This Study Directly From Their Current Study With No Break In Treatment. • Group 2 Includes Patients Who Previously Participated In An Adamas-Sponsored Study Of The Effectiveness Of Ads-5102, But Who Have Had A Time Gap Between The End Of That Study And Their Screening And Enrollment Into This Study. • Group 3 Includes Patients Who Would Have Been Excluded From The Adamas-Sponsored Studies Of The Effectiveness Of Ads-5102 Due To Having Undergone Deep Brain Stimulation (Dbs), Provided That Dbs Surgery Occurred Prior To 14 July 2014.
Adamas Amt-Ads-Pd302, Levodopa Induced Dyskinesia, Amantadine Extended Release, Espay, Parkinson's Disease
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