Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203957
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2005-09-13
Brief Title:
Study of KW-6002 Istradefylline in Parkinsons Disease in Patients With Motor Response Complications on Levodopa
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Long-Term Multicenter Open-Label Safety Study With Oral 20 or 40 mgd Doses of KW-6002 Istradefylline as Treatment for Parkinsons Disease in Patients With Motor Response Complications on Levodopa Therapy
Status:
COMPLETED
Status Verified Date:
2013-06
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:
None
Brief Summary:
The purpose of this study is to confirm the long term tolerability and safety of oral 20 or 40 mgd doses of Istradefylline
Detailed Description:
This is a Phase III open-label study in which patients with Parkinsons disease PD who have completed a qualifying istradefylline study will be treated with istradefylline for a period of up to one additional year Starting dosage of istradefylline will be 40 mgd and maintenance dosage will be at the discretion of the Investigator The available doses for istradefylline are 20 and 40 mgd Open-label istradefylline treatment will be initiated after a patient has satisfied all criteria for participation
Patients will undergo screening and baseline evaluations during which they will be assessed for eligibility Screening procedures will vary slightly depending upon the allocation of patients to one of the following two groups
Group A Patients who have completed double-blind treatment studies 6002-US-0 13 6002- US-Ol S or 6002-EU-007 immediately prior to entering this open-label trial and may have had an interruption of study drug of 14 days or less The screening visit for these patients will correspond to the final visit of the previous istradefylline study
Group B Patients who have previously completed double-blind treatment studies 6002-US- 013 6002-US-O 18 or 6002-EU-007 or discontinued from open-label study 6002-US-007 and have had an interruption of study drug greater than 14 days Screening for these patients will occur at the Week -2 and Day -1 Visits
Visits should occur in the ON state and procedures should be conducted in the order specified whenever possible
Safety outcomes will be assessed by physical examination including neurological examination clinical laboratory tests and 12-lead electrocardiogram ECG at screening and at selected subsequent scheduled visits Vital signs including weight concomitant medications and adverse events will be monitored regularly throughout the trial Changes in anti-parkinsonian medications will be permitted at the Investigators discretion
Patients will undergo screening and baseline evaluations during which they will be assessed for eligibility Screening procedures will vary slightly depending upon the allocation of patients to one of the following two groups
Group A Patients who have completed double-blind treatment studies 6002-US-0 13 6002- US-Ol S or 6002-EU-007 immediately prior to entering this open-label trial and may have had an interruption of study drug of 14 days or less The screening visit for these patients will correspond to the final visit of the previous istradefylline study
Group B Patients who have previously completed double-blind treatment studies 6002-US- 013 6002-US-O 18 or 6002-EU-007 or discontinued from open-label study 6002-US-007 and have had an interruption of study drug greater than 14 days Screening for these patients will occur at the Week -2 and Day -1 Visits
Visits should occur in the ON state and procedures should be conducted in the order specified whenever possible
Safety outcomes will be assessed by physical examination including neurological examination clinical laboratory tests and 12-lead electrocardiogram ECG at screening and at selected subsequent scheduled visits Vital signs including weight concomitant medications and adverse events will be monitored regularly throughout the trial Changes in anti-parkinsonian medications will be permitted at the Investigators discretion
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 |
|---|---|---|---|
| Kyowa Pharmaceuticals | None | None | None |