Parkinson Disease, Parkinson's Disease
Conditions
Keywords
ropinirole XL, REQUIP, Parkinson's disease, long term safety, efficacy, safety, ropinirole CR, ropinirole IR, open-label
Brief summary
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal). * Subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study 248. * Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System). * Provide written informed consent for this study. * Be willing and able to comply with study procedures.
Exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply: * Patients with any ongoing clinically significant adverse events at the end of the feeder studies. * Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma). * Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169). * Subjects with severe dizziness or fainting due to postural hypotension on standing. * Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome P 450 1A2 (CYP1A2 \[e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol\]) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period. * Women who are pregnant or breast-feeding. * Use of an investigational drug throughout the treatment period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 13 February 2004 through 31 March 2010 | AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Week 4 and Week 26 | The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day. Wk, Week. |
Countries
Belgium, Czechia, France, Hungary, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Study 101468/248 (this study, NCT00632736) was an open-label extension study with ropinirole extended release (XL) for subjects from studies 101468/165, 101468/168, and 101468/169 (NCT00381472).
Participants by arm
| Arm | Count |
|---|---|
| Ropinirole XL Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study. | 419 |
| Total | 419 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 104 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Non-compliance | 10 |
| Overall Study | Other | 16 |
| Overall Study | Protocol Violation | 14 |
| Overall Study | Sponsor terminated study | 5 |
| Overall Study | Withdrawal by Subject | 99 |
Baseline characteristics
| Characteristic | Ropinirole XL |
|---|---|
| Age, Continuous | 64.3 Years STANDARD_DEVIATION 9.81 |
| Body Mass Index (BMI) | 26.5 kilograms per square meters (kg/m^2) STANDARD_DEVIATION 4.48 |
| Race/Ethnicity, Customized American Hispanic | 5 participants |
| Race/Ethnicity, Customized Arabic/North African | 0 participants |
| Race/Ethnicity, Customized Black | 2 participants |
| Race/Ethnicity, Customized East & South East Asian | 2 participants |
| Race/Ethnicity, Customized South Asian | 0 participants |
| Race/Ethnicity, Customized Unknown | 1 participants |
| Race/Ethnicity, Customized White/Caucasian | 409 participants |
| Sex: Female, Male Female | 160 Participants |
| Sex: Female, Male Male | 259 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 261 / 419 |
| serious Total, serious adverse events | 109 / 419 |
Outcome results
Primary
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
Time frame: 13 February 2004 through 31 March 2010
Population: Safety Population: all participants who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants (Par.) reporting at least one AE | 365 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Par. reporting at least one SAE | 109 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Par. with drug-related AEs | 213 participants |
| Ropinirole XL | Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Par. with AEs leading to withdrawal | 106 participants |
Secondary
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day. Wk, Week.
Time frame: Week 4 and Week 26
Population: All participants enrolled into this study from parent study 101468/168 who received at least one dose of study medication. Only 74 participants completed this questionnaire at Week 4, whereas 87 participants completed this questionnaire at Week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Very much preferred three times a day, Wk 4, n=74 | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Much preferred three times a day, Week 4, n=74 | 0 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Preferred three times a day, Week 4, n=74 | 4 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Both regimens are about the same, Week 4, n=74 | 5 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Preferred once a day, Week 4, n=74 | 17 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Much preferred once a day, Week 4, n=74 | 18 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Very much preferred once a day, Week 4, n=74 | 28 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Very much preferred three times a day, Wk 26, n=87 | 4 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Much preferred three times a day, Week 26, n=87 | 1 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Preferred three times a day, Week 26, n=87 | 2 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Both regimens are about the same, Week 26, n=87 | 4 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Preferred once a day, Week 26, n=87 | 14 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Much preferred once a day, Week 26, n=87 | 20 participants |
| Ropinirole XL | Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 | Very much preferred once a day, Week 26, n=87 | 42 participants |