Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472355
Status:
WITHDRAWN
Last Update Posted:
2018-11-29
First Post:
2007-05-10
Brief Title:
Low Dose Apomorphine and Parkinsonism
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient study materials
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if low doses of apomorphine worsen the motor symptoms of Parkinsons disease
Detailed Description:
The goal of the study is to learn why some people with Parkinsons disease PD get worse right after taking PD medication such as carbidopalevodopa or as the medication is wearing off
In this study scientists will determine if apomorphine a drug used to treat symptoms of PD will worsen the motor symptoms of people with PD when low doses of the drug are given as a continuous subcutaneous infusion A continuous subcutaneous infusion means the drug is administered continuously through a small needle placed under the skin Apomorphine a PD drug that works similar to carbidopalevodopa will be used in this study because it is faster-acting and has a more brief effect than carbidopalevodopa
After the initial screening participants will enter a 3-day treatment phase during which they will receive in random order low dose apomorphine high dose apomorphine or placebo inactive substance All participants will receive the study drug for 2 of the days at 2 different doses low and high and a placebo for 1 day During the 3 days participants will provide blood samples and have their hearts monitored Parkinsonism will be monitored each day by speed of finger tapping foot tapping and walking as well as tremor and dyskinesia scores
Duration of the study for participants is approximately 4 to 5 days including 1-2 outpatient visits and a 3-day inpatient hospital stay
In this study scientists will determine if apomorphine a drug used to treat symptoms of PD will worsen the motor symptoms of people with PD when low doses of the drug are given as a continuous subcutaneous infusion A continuous subcutaneous infusion means the drug is administered continuously through a small needle placed under the skin Apomorphine a PD drug that works similar to carbidopalevodopa will be used in this study because it is faster-acting and has a more brief effect than carbidopalevodopa
After the initial screening participants will enter a 3-day treatment phase during which they will receive in random order low dose apomorphine high dose apomorphine or placebo inactive substance All participants will receive the study drug for 2 of the days at 2 different doses low and high and a placebo for 1 day During the 3 days participants will provide blood samples and have their hearts monitored Parkinsonism will be monitored each day by speed of finger tapping foot tapping and walking as well as tremor and dyskinesia scores
Duration of the study for participants is approximately 4 to 5 days including 1-2 outpatient visits and a 3-day inpatient hospital stay
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000334 | NIH | None | httpsreporternihgovquickSearchM01RR000334 |