ALLAY-LID II Study
Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given two to four times a day. The purpose of this multicenter, randomized, double-blind, parallel-group, 26-week study is to compare the efficacy and safety of two different dose levels of Amantadine extended release tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep. If you agree to participate you will be one of up to 162 subjects worldwide and one of up to four at Rush University Medical Center. Your participation will last up to 26 weeks and will involve 11 study visits, including nine study visits at Rush and two telephone visits.
In order to participate you must meet the following criteria:
- Be male or female 30 to 85 years old.
- Have levodopa induced, predictable peak-effect dyskinesia considered problematic and/or disabling.
- Be on stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days and be willing to remain on the same doses throughout the trial.
- Demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.
You will be excluded from the study if any of the following criteria apply to you:
- Have used amantadine within 14 days before study start, or previously had an adverse event to amantadine.
- Currently are taking neuroleptics and atypical antipsychotic agents, acetylcholinesterase inhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine if used in combination for treating dyskinesia.
- Have a history of neurosurgical intervention for treating Parkinson's s disease (i.e. pallidotomy or implanted with a deep brain stimulator).
- Have any medical condition or past medical history that would increase the risk of exposure to Amantadine HCl extended release tablets or interfere with safety and efficacy evaluations.
This is a partial list of inclusion and exclusion criteria.