Parkinson's Disease Update!
At Neurosearch, our goal is to advance the discovery of cures for neuro-degenerative disorders. This area of our website provides you with the latest information on open clinical research trails for Parkinson's Disease that are currently recruiting at our Ventura and Reseda locations. Please browse the study overviews below. If you feel that you or a loved one may be a candidate for any of the studies, please contact us to learn how we can become a partner in your treatment regimen - and eventually your recovery!
A study of an investigational medication for treatment of Orthostatic Hypotension.
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency. ..
Systolic blood pressure is transiently and minimally decreased in healthy individuals upon standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The compensatory mechanisms that regulate blood pressure upon standing are dysfunctional in subjects with orthostatic hypotension (OH), a condition that may lead to inadequate cerebral perfusion with accompanying symptoms of syncope, dizziness or lightheadedness, unsteadiness and blurred or impaired vision, among other symptoms.
The autonomic nervous system has a central role in the regulation of blood pressure. Primary Autonomic Failure is manifested in a variety of syndromes. Orthostatic hypotension is a usual presenting symptom. Primary Autonomic Failure may be the primary diagnosis, and classifications include pure autonomic failure (PAF), also called idiopathic orthostatic hypotension (Bradbury-Eggleston syndrome) autonomic failure with multiple system atrophy (Shy-Drager syndrome) and also Parkinson's disease. Regardless of the primary condition, autonomic dysfunction underlies orthostatic hypotension.
Orthostatic hypotension may be a severely disabling condition which can seriously interfere with the quality of life of afflicted subjects. Currently available therapeutic options provide some symptomatic relief in a subset of subjects, but are relatively ineffective and are often accompanied by severe side effects that limit their usefulness. Support garments (tight-fitting leotard) may prove useful in some subjects, but is difficult to don without family or nursing assistance, especially for older subjects. Midodrine, fludrocortisone, methylphenidate, ephedrine, indomethacin and dihydroergotamine are among some of the pharmacological interventions that have been used to treat orthostatic hypotension, although only midodrine is specifically approved for this indication. The limitations of these currently available therapeutic options, and the incapacitating nature and often progressive downhill course of disease, point to the need for an improved therapeutic alternative.
The current withdrawal design study will measure the efficacy of droxidopa on symptoms of neurogenic orthostatic hypotension in patients randomized to continued droxidopa treatment versus placebo, following 14 days of double-blind treatment.
droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the International non-proprietary name (INN) for a synthetic amino acid precursor of norepinephrine (NE), which was originally developed by Sumitomo Pharmaceuticals Co., Limited, Japan. It has been approved for use in Japan since 1989. Droxidopa has been shown to improve symptoms of orthostatic hypotension that result from a variety of conditions including Shy Drager syndrome (Multiple System Atrophy), Pure Autonomic Failure, and Parkinson's disease. There are four stereoisomers of DOPS; however, only the L-threo-enantiomer (droxidopa) is biologically active.
The exact mechanism of action of droxidopa in the treatment of symptomatic NOH has not been precisely defined; however, its NE replenishing properties with concomitant recovery of decreased noradrenergic activity are considered to be of major importance.
Droxidopa has been marketed in Japan since 1989. Data from clinical studies and post-marketing surveillance programs conducted in Japan show that the most commonly reported adverse drug reactions with droxidopa are increased blood pressure, nausea, and headache. In clinical studies, the prevalence and severity of droxidopa adverse effects appear to be similar to those reported by the placebo control arm.
If you or the person you care for may be eligible for a study of an investigational medication. Those who qualify will receive all study-related medical care at no cost. Compensation for time and travel may also be provided.
Study Title: Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease.
To assess the efficacy of rasagiline 1 mg as a first add on treatment to dopamine agonist therapy in early PD patients.
|Ages Eligible for Study:||
30 Years and older
Genders Eligible for Study:
Accepts Healthy Volunteers:
*Receiving stable dose of oral ropinirole or pramipexole whose SX are not optimally controlled or oral DA titration regimen was truncated due to intolerability:
1. Min dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
2. Stable Dopamine agonist TX must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline -M & F (BC) -≥ 30 YO
- *Receive rasagiline or other MAO inhibitor 60 days preceding baseline -receive levodopa > 21 consec. days within 90 days prior baseline
- *Mod to severe motor fluctuations
- *Hepatic impairment
- *Investigational meds 30 days preceding baseline
- *DA use > 5 years prior to baseline
- *Depression defined by BDI >score 14 -sig. cog impairment (MMSE score <26)
- *ICD based on the QUIP -PG or lactating or planning on PG next 18 weeks
- uncontrolled htn
- *Hypertensive controlled w/meds
- *Concomitant MAO inhibitors or meds contraindicated w/ MAO inhibitors not allowed
(All information taken from www.clinicaltrials.gov)
Do you or a loved one suffer from Parkinson’s Disease?
In addition to Parkinson's symptoms, are you or the person you care for bothered by any of the following experiences:
- Seeing things that other people cannot see?
- Hearing things that other people cannot hear?
- Believing that you cannot trust others?
- Believing that others are trying to hurt you?
- Other similar thoughts, beliefs, or feelings?
|Ages Eligible for Study:||
40 Years and older
Genders Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:*A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
*Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
*Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
*Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
*Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
*The subject is willing and able to provide consent
*Caregiver is willing and able to accompany the subject to all visits
Exclusion Criteria:*Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
*Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
*Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
*Subject has had a myocardial infarction in last six months
*Subject has any surgery planned during the screening, treatment or follow-up periods
Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
If you or the person you care for may be eligible for a study of an investigational medication. Those who qualify will receive all study-related medical care at no cost. Compensation for time and travel may also be provided.(All information taken from www.clinicaltrials.gov)