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| Sponsors and Collaborators: |
Parkinson's Disease and Movement Disorder Center of Boca Raton Valeant Pharmaceuticals International |
|---|---|
| Information provided by: | Parkinson's Disease and Movement Disorder Center of Boca Raton |
| ClinicalTrials.gov Identifier: | NCT00443872 |
Purpose
The purpose of the study is to determine if reducing or eliminating a dopamine agonist causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: orally disintegrating selegiline (Zelapar) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Adding Orally Disintegrating Selegiline (Zelapar) to Patients Taking Dopamine Agonists and Experiencing Complications |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
This is a one arm open label study
|
Drug: orally disintegrating selegiline (Zelapar)
1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated
|
Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain.
Levodopa is the most effective symptomatic treatment; however, long term use is associated with motor fluctuations (periods of return of PD symptoms when medication effect wears off) and dyskinesia (drug induced involuntary movements including chorea and dystonia). Once patients develop motor fluctuations treatment options include increasing the frequency of levodopa dosing, switching to sustained-release levodopa, adding other therapies including MAO-B inhibitors, dopamine agonists, COMT inhibitors and in patients with severe motor fluctuations deep brain stimulation surgery. There are no good evidence based studies indicating whether the use of one of these class of drugs is superior to the other nor are there treatment algorithms that recommend which class of drug should be initiated when the patients initially develop motor fluctuations. It is believed that the efficacy of the different drug classes is similar. However, the frequency of adverse effects may differ between drug classes, but such studies are lacking. In clinical practice when patients develop adverse effects to a drug from one class, a drug from another class is substituted in an attempt to maintain efficacy with reduced adverse effects.
Dopamine agonists often have a higher risk of adverse effects compared to MAO B inhibitors. Therefore, the rationale for this study is that the addition of orally disintegrating selegiline after the reduction or discontinuation of the offending dopamine agonist will result in comparable efficacy with reduced adverse events. This study will assess the safety and efficacy of the addition of orally disintegrating selegiline in PD patients who are having adverse effects to dopamine agonists for which a dose reduction of the dopamine agonist is being considered. All patients in the study will receive orally disintegrating selegiline 1.25 mg once a day and the dose will be increased to 2.5 mg once a day if tolerated.
Comparisons: The status of the adverse event at the end of the study while on orally disintegrating selegiline will be compared to the adverse event at the start of the study. In addition, efficacy will be compared at the start of the study while on the dopamine agonist to the end of the study with orally disintegrating selegiline.
Eligibility| Ages Eligible for Study: | 30 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Daytime sleepiness - must score >10 on ESS at Baseline; Pedal edema - bothersome/concerning to patient; Hallucinations - insight should be maintained; Impulsive behavior - not including behaviors that are harmful to the patient requiring immediate discontinuation of the agonist.
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Coastal Neurological Medical Group, Inc | |
| La Jolla, California, United States, 92037 | |
| University of California - Irvine | |
| Irvine, California, United States, 92697 | |
| University of Southern California | |
| Los Angeles, California, United States, 90093 | |
| The Parkinson's Institute | |
| Sunnyvale, California, United States, 94085 | |
| United States, Florida | |
| Parkinson's Disease and Movement Disorder Center of Boca Raton | |
| Boca Raton, Florida, United States, 33486 | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Iowa | |
| Methodist Plaza Speciality Clinic | |
| Des Moines, Iowa, United States, 50309 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Massachusetts | |
| Harvard Vanguard Medical Associates | |
| Boston, Massachusetts, United States, 02215 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Henry Ford Health Center - Franklin Pointe | |
| Southfield, Michigan, United States, 48034 | |
| United States, Minnesota | |
| Struthers Parkinson's Center | |
| Golden Valley, Minnesota, United States, 55427 | |
| United States, Ohio | |
| University of Toledo | |
| Toledo, Ohio, United States, 43614 | |
| United States, Rhode Island | |
| NeuroHealth Parkinson Disease and Movement Disorder Center | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Texas | |
| Neurology Specialists Dallas | |
| Dallas, Texas, United States, 75231 | |
| ETMC Neurological Institute | |
| Tyler, Texas, United States, 75701 | |
| Principal Investigator: | Rajesh Pahwa, MD | University of Kansas |
More Information
| Responsible Party: | University of Kansas Medical Center ( Rajesh Pahwa, MD ) |
| Study ID Numbers: | VAL-1.0-IV |
| Study First Received: | March 3, 2007 |
| Last Updated: | December 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00443872 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Parkinson's disease Dopamine agonist adverse effects MAO-B inhibitor orally disintegrating selegiline Zelapar |
|
Neurotransmitter Agents Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Cardiovascular Agents Brain Diseases Neurodegenerative Diseases Dopamine Agonists |
Neuroprotective Agents Selegiline Dopamine Parkinson Disease Movement Disorders Dopamine Agents Peripheral Nervous System Agents Parkinsonian Disorders |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cardiotonic Agents Basal Ganglia Diseases Physiological Effects of Drugs Antiparkinson Agents Dopamine Agonists Neurodegenerative Diseases Brain Diseases Neuroprotective Agents Dopamine Movement Disorders Therapeutic Uses Monoamine Oxidase Inhibitors |
Sympathomimetics Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Selegiline Parkinson Disease Autonomic Agents Dopamine Agents Parkinsonian Disorders Peripheral Nervous System Agents Central Nervous System Agents |