Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, levodopa, end of dose wearing off, OFF time
Brief summary
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.
Detailed description
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.
Interventions
DRUGIstradefylline
Oral istradefylline (KW-6002) 20 or 40 mg once daily.
Sponsors
Kyowa Kirin Co., Ltd.
Kyowa Kirin, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completion of study 6002-INT-001 * Not of childbearing potential
Exclusion criteria
* Cancer within 5 years of enrollment * ALT/AST levels \> 2.5 times ULN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as Measured by Adverse Events | Every 2 months up to 32 months | Investigation of the long-term tolerability and safety of istradefylline |
Countries
United States
Participant flow
Recruitment details
73 study centers in the US and Canada recruited subjects from the initiation date (28 October 2005). Patients who had previously participated in Study 6002-INT-001 were eligible to participate in this follow-on safety study,and hence had been taking istradefylline for at least a year.
Pre-assignment details
Subjects completing 6002-INT-001 immediately before entering the study had an interruption of study drug of 30 days or less. Qualifying subjects with an interruption of more than 30 days had their baseline visit after laboratory tests results were reviewed by the Investigator.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily. | 503 |
| Total | 503 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 73 |
| Overall Study | Lack of Efficacy | 27 |
| Overall Study | Not including due to early termination | 37 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Study termination by Sponsor | 323 |
| Overall Study | Withdrawal by Subject | 38 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 259 Participants |
| Age, Categorical Between 18 and 65 years | 244 Participants |
| Age, Continuous | 64.5 years STANDARD_DEVIATION 8.98 |
| Region of Enrollment Canada | 102 participants |
| Region of Enrollment United States | 401 participants |
| Sex: Female, Male Female | 155 Participants |
| Sex: Female, Male Male | 348 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 276 / 503 |
| serious Total, serious adverse events | 201 / 503 |
Outcome results
Primary
Safety as Measured by Adverse Events
Investigation of the long-term tolerability and safety of istradefylline
Time frame: Every 2 months up to 32 months
Population: Safety analysis set - all subjects who took at least one dose of study drug. 1 subject of the 504 enrolled did not take study drug and is not included in the safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Safety as Measured by Adverse Events | 477 participants |