Studies for Parkinson's Disease patients with Dyskinesia

ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)

Purpose: To evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD).

Duration:  25 weeks

Study design: Randomized, double blind

Inclusion Criteria:
30 years - 85 years
Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
On a stable regimen of antiparkinson's medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily
Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (caregiver/study partner assistance allowed)

Exclusion Criteria:
History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
History of seizures within 2 years prior to screening
History of stroke or transient ischemic attack (TIA) within 2 years prior to screening
History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer


Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease (INTREPID)

Purpose: The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Duration: 52 weeks

Study Design: Randomized, Double Blind, Active Comparator (Medium continuous dose of stimulation), Sham Comparator (Low intermittent dose of stimulation)

Inclusion Criteria:
Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.

Exclusion Criteria:
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
Any other active implanted devices including neurostimulators and /or drug delivery pumps
Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.

Last modified: Oct 28, 2014