INITIATIVES

Clinical Trials Department, Regional Parkinson Center


Due to the nature of the drug research conducted at the Regional Parkinson Center, names of the experimental medications must be omitted, but basic information on the progress of their research follows. For specifics, please visit Web sites such as www.clinicaltrials.gov and the National Institutes of Health.

Medications that can be anticipated in the near future include two new kinds of carbidopa/levodopa that are going through the clinical trial process. Conventional carbidopa/levodopa remains one of the standard medications used to treat Parkinson’s. As many patients are aware, however, the medication can sometimes be flawed in that it may not last long enough and can lead to involuntary movements or other unwanted side effects. These two new formulations aim to alleviate these problems, providing better control of symptoms, a longer-lasting effect, and decreased severity/prevalence of side effects.

Two additional new medications are from a class of drugs called dopamine antagonists. Both are, to an extent, unlike any other medications for PD that have been tested in the past. They both have the potential to improve normal neuron activity without triggering specific side effects. In the future they could provide an additional treatment option for patients struggling on conventional PD meds. Both have completed about 75% of the clinical trial process.

There also seems to be a new class of therapeutics on the horizon that could specifically target side effects of other PD drugs; for example, medications to significantly decrease dyskinesias (involuntary movements caused by certain PD drugs). If these treatments result in effectiveness, it would allow doctors to improve Parkinson symptoms while minimizing dyskinesias. There are currently three experimental medications designed for this purpose. The progress of these drugs varies, but researchers and clinicians hope to see one of these on the market soon.

Further down the line are forms of treatment that could potentially repair and rejuvenate damaged cells. That means that in the future, Parkinson specialists might actually be able to reverse the effects of the disease. There are at least two experimental medications in this category. Keep in mind that one must maintain a level of skepticism when learning about this type of medication. This theory of repairing damaged cells and reversing the effect of PD has been around for some time. These specific experimental agents still need to be rigorously tested to see whether they provide viable treatment options for Parkinson patients.

These are just a few of the medications in the pipeline for the treatment of PD. They are not yet approved and still need to be tested all around the world for safety and effectiveness, and none of these drugs represents a cure for the disease. What they do represent are steps in the right direction toward finding treatment options that are more predictable, increasingly safe, and extremely effective.

ADS-AMT-PD301: Efficacy and safety of ADS-5102 (Amantadine HCL) extended-release capsules for the treatment of levodopa-induced dyskinesia in Parkinson's disease patients (EASE LID study). Adamas Pharmaceuticals, Inc.

ADS-AMT-PD302: Open-label safety study of ADS-5102 (Amantadine HCL) extended-release capsules for the treatment of levodopa-induced dyskinesia (EASE LID 2 study). Adamas Pharmaceuticals, Inc.

ADS-AMT-PD304: ADS-5102 (Amantadine HCL) extended-release efficacy and safety study in Parkinson's disease patients with levodopa-induced dyskinesia (EASE LID 3 study). Adamas Pharmaceuticals, Inc.

NOH-401: A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy. Chelsea Therapeutics.

CVT-301-004: A Phase 3 randomized, double-blind, placebo-controlled study investigating the efficacy and safety of CVT-301 (levodopa inhalation powder) in Parkinson's disease patients with motor response fluctuations ("off" phenomenon). Civitas Therapeutics, Inc.

CVT-301-004E: A 12-month, dose-level-blinded study investigating the safety and efficacy of CVT-301 (levodopa inhalation powder) in Parkinson's disease patients with motor response fluctuations ("off" phenomenon). Civitas Therapeutics, Inc.

DaT-SPECT: Validation of DaT-SPECT scanning for detection of Parkinsonian disease and related disorders using neuropathologically confirmed PD from human brain tissue.

                                                                                                                                              the above added December 2014


ADS-PAR-AM201: Extended-release Amantadine safety and efficacy study in levodopa-induced dyskinesia.

SP1055: A multi-center, double-blind, randomized, placebo-controlled, parallel group study to assess the effect of Rotigotine on motor symptoms in patients with advanced Parkinson disease with motor fluctuations and gastroparesis. Phase 3B.

SP953: Phase of trial: 4. Named patient program with Rotigotine transdermal system.

                                                                                                                                              the above added July 2012

TVP 1012-501: An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson disease subjects who participated in the ADAGIO study.

P58/07CL/ST/0902: A Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety, and tolerability of Cogane (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson disease, when administered once daily for 28 weeks.

P05664: A Phase 3, double-blind, double-dummy, placebo- and active-controlled dose range-finding efficacy and safety study of Preladenant in subjects with early Parkinson disease.

P04938: A Phase 3, 12-week, double-blind, double-dummy, placebo- and active-controlled efficacy and safety study of Preladenant in subjects with moderate to severe Parkinson disease.

P06153: A Phase 3, 40-week, active-controlled, double-blind, double-dummy extension study of Preladenant in subjects with moderate to severe Parkinson disease.

IPX066-B11-01: An open-label conversion study of carbidopa-levodopa extended-release (CD-LD ER) taken alone or in combination with carbidopa-levodopa immediate release (IR) to IPX066 in subjects with advanced Parkinson disease.

ACP103-020: A multi-center, placebo-controlled, double-blind trial to examine the safety and efficacy of Pimavanserin in the treatment of psychosis in Parkinson disease.

ACP103-015: A multi-center, open-label extension study to examine the safety and tolerability of ACP-103 in the treatment of psychosis in Parkinson disease.