Last updated: 11/07/2018 03:42:08
A fixed dose, dose response study for ropinirole prolonged release in patients with early stage Parkinson’s DiseaseTANDEM-662
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson's Disease
Trial description: This study is a fixed dose, dose response study to characterize the doseresponse for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). Afterscreening and baseline assessments, subjects will be randomized to one of six final targettreatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consistof a screening period, an up-titration period, a maintenance period, a down titrationperiod and a follow up period. This study utilizes change from baseline in the UPDRSmotor score as the primary endpoint, in line with that used in the ropinirole PRmonotherapy pivotal study (SK&F101468/168). Clinical review of the primary andsecondary endpoints will be performed in order to establish the lowest maximallyeffective therapeutic dose.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) motor score
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Secondary outcomes:
Number of participants with a >=5 points reduction from Baseline in UPDRS motor score
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of participants with a >=10 points reduction from Baseline in UPDRS motor score
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Number of participants with a >=10 points reduction from Baseline in UPDRS Parts II and III combined
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder rate defined as participants with a >=30% reduction in Baseline UPDRS motor score
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change from Baseline in UPDRS Parts II and III combined
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change from Baseline in UPDRS Activities of Daily Living
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change from Baseline in the total UPDRS score (Parts I-III)
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Change from Baseline in the UPDRS Part I (mentation)
Timeframe: Baseline and Week 4 of the Maintenance Period (Study Week 17)
Responder rate according to the Clinical Global Impression – Global Improvement (CGI-I) scale
Timeframe: Week 4 of the Maintenance Period (Study Week 17)
Percentage of participants withdrawn from the study due to lack of efficacy
Timeframe: Up to Week 4 of the Maintenance Period (Study Week 17)
Interventions:
Drug: ropinirole monotherapy
Drug: placebo monotherapy
Enrollment:
186
Observational study model:
Not applicable
Primary completion date:
2014-30-04
Time perspective:
Not applicable
Clinical publications:
Zesiewicz T, Chriscoe S, Jimenez T, Upward J, VanMeter S. A Fixed-Dose, Dose–response Study of Ropinirole Prolonged Release in Early Stage Parkinson’s Disease. Neurodegener Dis Manag. 2017;7(1):49-59.
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
January 2012 to April 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
30+ years
Accepts healthy volunteers
No
- Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr
- criteria Stages I-III.)
- Subjects with Parkinson’s disease in whom dopaminergic therapy is not warranted at
- the time of screening.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages I-III.)
- Subjects aged 30 years or greater at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomization and one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, surgical sterilisation, male partner sterilization, intrauterine device [IUD], or double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository.
- A baseline UPDRS motor score of at least 10.
- Limited prior exposure to low or moderate doses of L-DOPA (up to 3 months in total) or dopamine agonists including ropinirole (up to 6 months in total) is allowed provided treatment is discontinued for a minimum of 4 weeks prior to screening.
- Provide written informed consent for this study.
- Be willing and able to comply with study procedures.
Exclusion criteria:
- Subjects with Parkinson’s disease in whom dopaminergic therapy is not warranted at the time of screening.
- Subjects with severe, clinically significant condition(s) other than Parkinson’s disease which, in the opinion of the investigator, render the subject unsuitable for the study (e.g., psychiatric, haematological, renal, hepatic, endocrinology, neurological [other than Parkinson’s disease], cardiovascular, or active malignancy [other than basal cell carcinoma]).
- Subjects with crippling degenerative arthritis or other physical or mental conditions precluding accurate assessment of efficacy or safety.
- Subjects with prior or current major psychosis (e.g., schizophrenia or psychotic depression) e.g. scoring 3 or 4 on UPDRS item 2 [thought disorder] or item 3 [depression].
- Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1 [mentation].
- Subjects with severe dizziness or fainting due to postural hypotension on standing.
- Subjects with a personal history of melanoma.
- Subjects with clinically significant abnormalities in laboratory or ECG tests at Screening. If findings are outside the normal range and the subject is included, it must be documented by the investigator that the findings are not of clinical significance.
- Subjects diagnosed with an impulse control disorder. The modified MIDI will be conducted at screening. Subjects who score positive for this screen must be referred to a specialist for diagnostic evaluation prior to enrolling (screening) in the study.
- Subjects with an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Subjects with a history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
- Current alcohol or drug dependence.
- Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole.
- Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to baseline (randomization).
- Subjects on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to baseline (randomization) through the end of the treatment period. Smokers should maintain normal smoking habit.
- Women who are pregnant or breast-feeding.
- Use of an investigational drug from 30 days or 5 half-lives (which ever is longer) prior to baseline (randomization) to the end of the treatment period.
Trial location(s)
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ventura, California, United States, 93003
Status
Study Complete
Location
GSK Investigational Site
Reseda, California, United States, 91355
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33486
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90505
Status
Study Complete
Location
GSK Investigational Site
Sungnam -Gyeonggi-do, South Korea, 463707
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Forest Hills, New York, United States, 11375
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45227
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pasedena, California, United States, 91105
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2014-30-04
Actual study completion date
2014-30-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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