A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease

NCT ID: NCT01485172

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-04-30

Brief Summary

This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn & Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ropinirole

ropinirole 2, 4, 8, 12, or 24 mg/day

Group Type: EXPERIMENTAL

ropinirole monotherapy

Intervention Type: DRUG

ropinirole as monotherapy in Parkinson's disease

placebo

placebo comparator 2, 4, 8, 12, or 24 mg/day

Group Type: PLACEBO_COMPARATOR

ropinirole monotherapy

Intervention Type: DRUG

ropinirole as monotherapy in Parkinson's disease

placebo monotherapy

Intervention Type: DRUG

placebo as monotherapy in Parkinson's disease

Interventions

ropinirole monotherapy

ropinirole as monotherapy in Parkinson's disease

Intervention Type: DRUG

placebo monotherapy

placebo as monotherapy in Parkinson's disease

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Pasadena, California, United States

GSK Investigational Site

Reseda, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Ventura, California, United States

GSK Investigational Site

Boca Raton, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Forest Hills, New York, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Chelyabinsk, , Russia

GSK Investigational Site

Kazan', , Russia

GSK Investigational Site

Krasnoyarsk, , Russia

GSK Investigational Site

Kursk, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Omsk, , Russia

GSK Investigational Site

Perm, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saratov, , Russia

GSK Investigational Site

Smolensk, , Russia

GSK Investigational Site

Ufa, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Banská Bystrica, , Slovakia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Busan, , South Korea

GSK Investigational Site

Donggu Gwangju, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Sungnam -Gyeonggi-do, , South Korea

Countries

United States; Estonia; Russia; Slovakia; South Korea

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

111662

Identifier Type: -

Identifier Source: org_study_id