• PDtrials - Parkinson's Disease Clinical Trials
• /Browse By Type
• /Intervention

Official Study Title: A randomized, double-blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. placebo-controlled, two-way cross-over study to explore the effects of 7 days dosing with SYN115 20 mg p.o. BID or 60 mg p.o. BID on clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. and fMRI response to intravenous levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. in patients with mild to moderate PD
Sponsor: Synosia Therapeutics, Inc.
Clinicaltrials.gov ID: NCT00605553
Study ID: SYN115-CL01

Summary

While in this study, all participants will continue taking their routine Parkinson’s medication. In addition, to routine medications, all participants will be randomly assigned (like a coin toss) to either receive first SYN115 and then placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. (like a sugar pill) or first placebo and then SYN115, each for seven days. Neither participants nor the study doctor will know if SYN115 is provided first or second. There will be six days in the middle when neither SYN115 nor placebo will be added to the routine Parkinson’s medication. Images of the brain, taken with an MRI, will be used to see if there are differences in response. Memory tests and motor (movement) evaluations will also be used. The results of how each participant responds to levodopa while on SYN115 will be compared to how each participant responds to levodopa while on placebo.

Study Phase

Phase 2
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than one month
• Screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. is followed by 3 visits that last up to 7 hours. After screening, all 3 visits occur within 1 month. Participants will also be contacted by phone once between visits, and once again after all the visits are done.

Eligibility

• Minimum Age: 40
• Maximum Age: 70
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of Parkinson’s Disease (mild or moderate)
• Receiving treatment with levodopa/carbidopa  CarbidopaDrug given in combination with levodopa to ensure that more of the latter reaches the brain and changes into dopamine, rather than being broken down in the bloodstream. This allows for lower doses of levodopa to be used, reducing the risk of nausea, vomiting, and other side effects.
• On stable dose of anti-parkinson’s treatment for 30 days prior to screening
• Age 40 to 70 years
• Able to sign an IRB  IRBA committee of physicians, statisticians, researchers, community advocates, and others chosen by an institution to initially approve and periodically review research projects involving human participants. Federal law requires this to ensure protection of participants’ safety, rights and welfare. approved informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial.
• Men and women agree to use adequate birth control during study period
• ECG (electrocardiogram, for the heart) measurements are within normal limits
• Able to understand study requirements

Exclusion Criteria

• Diagnosis of non-idiopathic Parkinson’s, or a parkinsonian syndrome
• Received treatment with other investigational drug  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. 30 days prior to study entry
• Using prohibited medications
• Significant neurological illness other than Parkinson's
• IQ less than 70 on IQ test
• History of psychosis  PsychosisA loss of contact with reality often accompanied by hallucinations. Psychosis can be caused by some PD medications and is more common in patients with advanced Parkinson's. or on anti-psychotic medication
• Current serious medical or mental illness
• History of substance abuse
• History of head injury with loss of consciousness
• History of brain surgery
• Complicating factors for an MRI, like claustrophobia, metal implants or other implantable devices
• Abnormal liver function tests and/or hepatitis or cholangitis or abnormal thyroid hormone levels
• Gilbert’s disease
  
• Pregant or nursing
  

Enrollment

Expected Enrollment: 32 (US)
Date Enrollment Began: Apr 17 2008
Last Updated Date: May 16 2008
Trial Post Date: May 16 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00605553?term=NCT00605553&rank=1

Primary Contacts and Locations

All States

• Chris Resburg — Associate Director Clinical Operations
  Synosia Therapeutics, Inc.
  cresburg@synosia.com
  Phone: (650) 244-4870
  All States
  USA
  

View All Locations and Contacts