Treatment of Parkinson's Disease With a Transdermal Skin Patch

NCT00001931 | Completed Phase 2

• 2 other identifiers: 99010499-N-0104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Continuous Stimulation; Dose Finding; Skin Patch

Interventions

N-0923 DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.

  PMID: 9358193 BACKGROUND

• Chase TN, Engber TM, Mouradian MM. Contribution of dopaminergic and glutamatergic mechanisms to the pathogenesis of motor response complications in Parkinson's disease. Adv Neurol. 1996;69:497-501. No abstract available.

  PMID: 8615171 BACKGROUND

• Bravi D, Mouradian MM, Roberts JW, Davis TL, Sohn YH, Chase TN. Wearing-off fluctuations in Parkinson's disease: contribution of postsynaptic mechanisms. Ann Neurol. 1994 Jul;36(1):27-31. doi: 10.1002/ana.410360108.

  PMID: 8024257 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: December 10, 2002
• Study Start: May 1, 1999
• Study Completion: January 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-06

Locations

US (1)