Status:
COMPLETED
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa
Lead Sponsor:
GlaxoSmithKline
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This is a phase III, multicenter, randomized, double-blind, parallel group, placebo-controlled study to compare the efficacy of 6-months therapy of ropinirole Prolonged Release (PR) with that of place...
Eligibility Criteria
Inclusion
- Men or non-pregnant/non-breast-feeding women of at least 30 years of age at screening.Women of child-bearing potential must be practicing a clinically accepted method of contraception (such as oral contraception, surgical sterilization, intrauterine device \[IUD\], or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception \[i.e. Norplant System\]), during the study and for at least one month prior to randomisation and one month following completion of the study.
- Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn \& Yahr criteria Stages II-IV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple on/off fluctuations)
- Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
- Provide written informed consent for this study
- A minimum of 3 hours awake time"off " for each diary day recorded during the Placebo Run-In Period.
- Be willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.
Exclusion
- Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa.
- Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson.s Disease), or cardiovascular disease or active malignancy (other than basal cell cancer);
- Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG;
- Unstable liver disease, cirrhosis, known biliary abnormalities(except Gilbert's syndrome or asymptomatic gallstones) or AST or ALT\>2xULN or alk phos and bilirubin\>1.5 xULN
- Recent history of severe dizziness or fainting due to postural hypotension on standing.
- Clinical dementia that in the judgment of the investigator would preclude assessment of the subject.
- Recent history or current evidence of drug abuse or alcoholism.
- Consumption of any dopamine agonist within four weeks of the screening visit.
- 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 PR.
- 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 enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through the end of the Treatment Period.
- Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).
Key Trial Info
Start Date :
February 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2011
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT01154166
Start Date
February 15 2010
End Date
September 29 2011
Last Update
August 6 2018
Active Locations (18)
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1
GSK Investigational Site
Guangzhou, Guangdong, China, 510120
2
GSK Investigational Site
Wuhan, Hubei, China, 430022
3
GSK Investigational Site
Suzhou, Jiangsu, China, 215004
4
GSK Investigational Site
Xi'an, Shaanxi, China, 710061