Clinical Trials in Progress

: (SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia)
 Currently recruiting...
The Parkinson Study Group (PSG), under the direction of the SYNAPSE Steering Committee, is conducting a placebo-controlled, randomized, double-blind study to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.

SYN120 is an orally administered antagonist of the serotonin 5-HT6 receptor in development for the treatment of cognitive disorders, including dementia associated with Parkinson’s disease. 5-HT6 receptors are located almost exclusively in the brain and blocking them results in increased concentrations of acetylcholine and glutamate, two neurotransmitters known to facilitate cognition. In addition to blocking the 5-HT6 receptor, SYN120 also antagonizes 5-HT2a receptors, an action that may help treat psychosis associated with Parkinson’s disease. Thus SYN120 offers a unique therapeutic strategy by combining its procognitive and antipsychotic potential.

The SYNAPSE study seeks to randomize 1:1 eighty patients with PDD and on a stable dose of an acetylcholinesterase inhibitor to placebo or SYN120 dosed once daily over a 16 week treatment period. In addition to assessing safety and tolerability, the main goal of the study is to establish efficacy of SYN120 on cognition using the Cognitive Drug Research (CDR) Computerized Cognition Battery as the primary efficacy endpoint. The study will be conducted at approximately 12 PSG sites in the United States specializing in cognitive dysfunction in Parkinson's disease. Biotie and the PSG share responsibility for the design and execution of the study, and initial results of the study are expected in by the end of 2016.

There is no cost to participate in SYNAPSE. Interested individuals with PDD may obtain more information regarding this trial via its entries on clinical trial websites of the US National Institutes of Health at or The Michael J. Fox Trial Finder website at

To read the Biotie announcement of the SYNAPSE study…
STEADY-PD III: Efficacy of Isradipine in early Parkinson Disease

Currently recruiting...


The Parkinson Study Group (PSG), under the direction of Tanya Simuni, MD (Northwestern University), and Kevin Biglan, MD, MPH (University of Rochester), is conducting a multi-center, randomized, double-blind, placebo-controlled study of isradipine in individuals with early Parkinson disease (PD) called STEADY-PD III. The purpose of STEADY-PD III is to assess the potential effect of isradipine on slowing the progression of PD. Approximately 56 research centers across North America will enroll up to 336 subjects.

Isradipine is a medication that is approved for the treatment of high blood pressure by the Food and Drug Administration Agency (FDA), but not for the treatment of PD. Isradipine has been shown to have a neuroprotective effect in preclinical models of parkinsonism (Chan, Guzman et al. 2007). A recently completed Phase II study funded by the MJFF in a PD population demonstrated that isradipine is safe and well tolerated up to the dose of 10 mg (2013).

STEADY-PD III is being conducted under a research grant award from the National Institute of Neurological Disorders and Stroke.

For contact information on participating sites in this study, visit: or call 1-855-825-33901-855-825-3390.

(2013). "Phase II safety, tolerability, and dose selection study of isradipine as a potential disease-modifying intervention in early Parkinson's disease (STEADY-PD)." Mov Disord.

Chan, C. S., et al. (2007). "'Rejuvenation' protects neurons in mouse models of Parkinson's disease." Nature 447(7148): 1081-1086.

MOVE-PD (A Phase II Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation)

- Enrollment is completed -

The Parkinson Study Group (PSG), under the direction of the MOVE-PD Steering Committee, is conducting a clinical trial to test a new treatment for chronic constipation among Parkinson’s disease (PD) patients. Constipation is a common non-motor symptom of PD, which can cause extreme discomfort.

Researchers will investigate how individuals with PD and chronic constipation respond to the drug RM-131, as compared to placebo.

The PSG is a not-for-profit group of physicians and other clinical researchers who are experienced in the care of PD patients and dedicated to clinical research of PD. The study is sponsored by Rhythm Pharmaceuticals, Inc. (Boston, Massachusetts) with funding provided by The Michael J. Fox Foundation for Parkinson’s Research, the world’s largest nonprofit funder of Parkinson’s research. The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today.

“We are excited to work with Rhythm to investigate the safety and tolerability of this interesting and innovative experimental treatment for chronic constipation in Parkinson’s disease, RM-131. We hope this is a step to addressing this large unmet need for individuals with PD," said Ronald F. Pfeiffer, M.D., principal investigator of MOVE-PD and director of the Division of Neurodegenerative Diseases at the University of Tennessee Health Science Center.

Parkinson’s disease is a degenerative disorder of the central nervous system that is more common in older people, with most cases occurring after the age of 50. Symptoms include the more recognized resting tremor and slowness of movement, as well as cognitive impairment and mood disorders. Gastrointestinal (GI) disorders also are common in PD; among these is constipation, which can be hard to treat.

This clinical trial will test a new investigational drug called RM-131 to see if it will help to improve bowel function and reduce discomfort from constipation when used over a 14-day period. There are two 14-day periods in the study. Each participant will receive the inactive drug, called placebo, in one period and either the placebo or RM-131 in the other. Participants will not know which treatment they are receiving and at which part of the study.

RM-131 is administered by a daily injection under the skin. Early studies in healthy volunteers have shown that RM-131 is safe and well-tolerated when taken for one to 14 days and that it improved the rate of stomach emptying (an important process in healthy GI functioning), medication absorption, and bowel function necessary to prevent constipation.

For more information regarding this trial visit [NCT01955616].
NIC-PD (A Randomized, Placebo-controlled, Double-blind, Multi-centre Trial to Assess the Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease) in Germany and the USA.
March 21, 2014: Randomization is complete!  
Principal Investigator, Dr. Jim Boyd, discusses the trial via the following Podcast, click on the link below and listen now:  

The Parkinson Study Group (PSG), under the direction of  Wolfgang Oertel, MD (Philipps University, Marburg Germany), and James Boyd, MD (University of Vermont), is conducting a  randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA. The purpose of the study is to demonstrate that transdermal nicotine treatment retards disease progression as measured by change in the  Unified Parkinson's Disease Rating Scale (UPDRS) (part I, II, III) score between baseline and after 52 weeks of study treatment plus two more months following a wash-out period (60 weeks).  Approximately 20 research centers in the United States and Germany will enroll up approximately 160 subjects for 12 months each.

The nicotine transdermal patch is a medication that is approved as a smoking cessation aide by the Food and Drug Administration Agency (FDA), but not for the treatment of PD. Up to now no drugs are available that can delay or halt the progression of Parkinson’s disease. Nicotine is a promising substance for this purpose for several reasons. PD is much less prevalent among smokers compared to never-smokers. Over 40 independent epidemiological studies suggest a protective effect cigarette smoking against development of PD, and this effect is suspected to be caused by nicotine.  In experimental neuroscience, -including research using several PD animal models, nicotine has shown to protect against the loss of the dopamine-producing cells lost in PD.  Additionally, the drug is widely available and exhibits a favorable safety profile.

This study is being conducted under two research grant awards from the Michael J. Fox Foundation (MJFF) one to Philipps University, Marburg, Germany and the other to the University of Rochester, Rochester, New York.

If you are interested in learning more about this study, please see the study on (NCT01560754) where the participating sites are listed as well as pertinent inclusion and exclusion criteria for participation.