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> does  anyone know   anything about   patch?  where, when,  how. nancy spires

Hi Nancy,
There was this tidbit in '98....
The dopamine or Sinemet patch, also known as N-0923, and well-publicized in Reader's Digest
has been studied by researchers in Virginia. This treatment is not Sinemet (levodopa/carbidopa)
but rather resembles Sinemet as it is a dopamine agonist. Most likely this medication will not be
any better in improving symptoms than other available dopamine agonists such as pramipexole,
ropinirole and pergolide. Research has been slow on this compound and there have been no
national studies to show that is effective in many patients.
http://www.clinical-services.med.umn.edu/movement-disorders/park3.htm

I searched the Clinical Trials Search site for N-0923
http://clinicaltrials.gov/ct/gui/c/r

Treatment of Parkinson's Disease with a Transdermal Skin Patch
This study is currently recruiting patients.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Purpose
Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine.  This
occurs as a result of destructive changes in an area of the brain responsible for making
dopamine, the basal ganglia.  Muscle tremors, rigidity of movement, shuffling footsteps, droopy
posture, and a mask-like expression on the face characterize Parkinson's disease.

This study is designed to determine the effects of a new drug, N-9023.  The drug acts like
dopamine and can be given through a skin patch (transdermal) for treatment of parkinsonian
symptoms.

The goals of this study are to find out whether N-9023 is useful in treating the signs and
symptoms of Parkinson's disease and to determine the best dose of N-9023 that is safe and
effective.

Condition:      Parkinson Disease
Treatment or Intervention:    Drug: N-0923 TDS
Phase:  Phase II
MEDLINEplus related topics:  Parkinson's Disease
Study Type: Clinical Trial
Official Title: Transdermal Application of Dopamine Agonist N-0923 in Parkinson's Disease
Further Study Details: The acute safety and antiparkinsonian efficacy of transdermally delivered
N-0923 will be evaluated in patients with Parkinson's disease.  This dopamine receptor agonist
will be administered transdermally under double-blind conditions, in a rising dose paradigm.
Antiparkinsonian activity will be quantified by means of standard rating scales.  Possible adverse
events will be assessed by appropriate clinical and laboratory tests.
 
Eligibility
Genders Eligible for Study:             Both

Criteria
All patients will carry a diagnosis of Parkinson's Disease based on the presence of a
characteristic clinical history and neurological findings.  Symptom severity will range from Hoehn
& Yahr stage II-IV.
Males and females between the ages 30-76 are eligible for the study.
Initial emphasis will be on patients who are taking few or no other medications than levodopa for
their Parkinson's disease.
No presence or history of any medical condition that can reasonably be expected to subject the
patient to unwarranted risk.
No patients with a history of significant cardiac (myocardial infarction within 12 months prior to
study, dysrhythmia; QTc intervals greater than 440 msec).
No patients who are convulsive, hepatic, or with renal disorders (exceeding the upper limit of
normal values for LFT's and creatinine respectively).
No patients with evidence of other serious medical illness, a  history of alcohol or drug abuse,
those who have participated in an investigational trial within 28 days prior to study, and pregnant
or nursing women or anyone not practicing effective means of birth control.
 Location and Contact Information
Maryland
National Institute of Neurological Disorders and Stroke (NINDS), 
9000 Rockville Pike  
Bethesda,   Maryland,      20892,  
United States; 

Recruiting PRPL         
Warren G. Magnuson Clinical Center
National Institutes of Health  
Bethesda,   Maryland,      20892-4754,  
United States       
1-800-411-1222        
[log in to unmask] 

Publications that lead up to this study
Marsden.  1994.  Problems with long-term levodopa therapy for Parkinson's disease,  Clin
Neuropharmacol,  Vol. 17,  p. S32
Chase.  1996.  Contribution of dopaminergic and glutamatergic mechanisms to the pathogenesis
of motor response complications in Parkinson's disease,  Adv Neurol,  Vol. 69,  p. 497
Bravi.  1994.  Wearing-off fluctuations in Parkinson's disease: contribution of postsynaptic
mechanisms,  Ann Neurol,  Vol. 36,  p. 27
Study ID Numbers                     99-N-0104
NLM Identifier                     NCT00001931
Date study started May 5, 1999
Recruitment status verified          June 22, 2000
Last Updated          June 22, 2000

U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
http://clinicaltrials.gov/ct/gui/c/a2r/action/GetStudy/screen/ResultScreen?order=1&xml_file_id=x
mlfiles%2FCC__99-N-0104.xml%40csdb&JServSessionIdcs_current=0wi8y7zyom

More Info...
NIH Clinical Research Studies
Protocol Number: 99-N-0104
Title: Transdermal Application of Dopamine Agonist N-0923 in Parkinson's Disease

Number: 99-N-0104

Summary:
Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This
occurs as a result of destructive changes in an area of the brain responsible for making
dopamine, the basal ganglia.  Muscle tremors, rigidity of movement, shuffling footsteps, droopy
posture, and a mask-like expression on the face characterize Parkinson's disease.

This study is designed to determine the effects of a new drug, N-9023.  The drug acts like
dopamine and can be given through a skin patch (transdermal) for treatment of parkinsonian
symptoms.
The goals of this study are to find out whether N-9023 is useful in treating the signs and
symptoms of Parkinson's disease and to determine the best dose of N-9023 that is safe and
effective.
Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): Children
Eligibility Criteria:
All patients will carry a diagnosis of Parkinson's Disease based on the presence of a
characteristic clinical history and neurological findings.  Symptom severity will range from Hoehn
& Yahr stage II-IV.
Males and females between the ages 30-76 are eligible for the study.
Initial emphasis will be on patients who are taking few or no other medications than levodopa for
their Parkinson's disease.
No presence or history of any medical condition that can reasonably be expected to subject the
patient to unwarranted risk.
No patients with a history of significant cardiac (myocardial infarction within 12 months prior to
study, dysrhythmia; QTc intervals greater than 440 msec).
No patients who are convulsive, hepatic, or with renal disorders (exceeding the upper limit of
normal values for LFT's and creatinine respectively).
No patients with evidence of other serious medical illness, a  history of alcohol or drug abuse,
those who have participated in an investigational trial within 28 days prior to study, and pregnant
or nursing women or anyone not practicing effective means of birth control.
Special Instructions: Currently Not Provided
Disease Category: Nervous System and Sense Organs
Keywords: Skin Patch Continuous Stimulation Dose Finding
Recruitment Keywords: None
Investigational Drug(s): N-0923 TDS
Investigational Device(s): None
Contacts:
Patient Recruitment and Public Liaison Office, CC.

Building 61

10 Cloister Court

Bethesda, Maryland 20892-4754

Long Distance Calls: 1-800-411-1222

Fax: (301) 480-9793

Electronic Mail:[log in to unmask]
Citations:
Marsden.  1994.  Problems with long-term levodopa therapy for Parkinson's disease,  Clin
Neuropharmacol, Vol. 17, p. S32
Chase.  1996.  Contribution of dopaminergic and glutamatergic mechanisms to the pathogenesis
of motor response complications in Parkinson's disease,  Adv Neurol, Vol. 69, p. 497
Bravi.  1994.  Wearing-off fluctuations in Parkinson's disease: contribution of postsynaptic
mechanisms,  Ann Neurol, Vol. 36, p. 27

If you have:
Questions about participating in a study, please contact the Patient Recruitment and Public
Liaison Office, CC.

Questions about specific studies, or the database in general, please contact the Protocol
Coordination Service Center, CC.

Technical questions regarding the Clinical Center web site, please contact the Information
Systems Department, CC.


National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 08/15/2000


http://clinicalstudies.info.nih.gov/detail/A_1999-N-0104.html

Someone with time can look in the LIST archives for "transdermal patch"
or "N-0923".  I'm sure there is plenty to choose from.......

If you don't know how to search the LIST archive just ask....
(I did about 3 years ago...)

Cheeerrrrz ........... murray

We try to make a difference
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