Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443872
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2007-03-03
Brief Title:
Efficacy of Orally Disintegrating Selegiline in Parkinsons Patients Experiencing Adverse Effects With Dopamine Agonists
Sponsor:
Parkinsons Disease and Movement Disorder Center of Boca Raton
Organization:
Parkinsons Disease and Movement Disorder Center of Boca Raton
Study Overview
Official Title:
Adding Orally Disintegrating Selegiline Zelapar to Patients Taking Dopamine Agonists and Experiencing Complications
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AtoZ
Brief Summary:
The purpose of the study is to determine if reducing or eliminating a dopamine agonist DA 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 Parkinsons disease PD symptoms
Detailed Description:
Parkinsons 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 monoamine oxidase type B MAO-B inhibitors dopamine agonists catechol-o-methyltransferase 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 125 mg once a day and the dose will be increased to 25 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
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 125 mg once a day and the dose will be increased to 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None