A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson Disease
Intervention: ropinirole monotherapy (Drug); placebo monotherapy (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
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.
Clinical Details
Official title: A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in UPDRS Motor Score from Baseline
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
US GSK Clinical Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Fountain Valley, California 92708, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Pasedena, California 91105, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Reseda, California 91355, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Ventura, California 93003, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Boca Raton, Florida 33486, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Tampa, Florida 33612, United States; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Forest Hills, New York 11375, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Cincinnati, Ohio 45227, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Richmond, Virginia 23249, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
Additional Information
Starting date: January 2012
Last updated: September 20, 2012
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