Clinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

Condition(s) targeted: Parkinson's Disease

Intervention: ropinirole IR (Drug); ropinirole PR/XR (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa in a double-blind, parallel group comparison study.

Official title: Clinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from Week 0 in Japanese UPDRS Part III total scores at Week 24 in the Non-inferiority verification phase

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Inclusion criteria at the start of the screening

- Patients who are diagnosed with advanced Parkinson's disease with severity of the

modified Hoehn & Yahr criteria Stages II-IV.

- Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening

phase and demonstrating lack of control with L-dopa therapy in the following circumstances.

Wearing-off phenomena On-off fluctuations Delayed-on/No on phenomena Not adequately controlled on L-dopa

- QTc criteria (either QTcb or QTcf, machine or manual overread, males or females):

QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block - values

based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period.

- Age: 20 years or older(at the time of informed written consent)

- Informed consent: Patients who are able to give informed written consent in person.

(i. e. patients who are capable of giving informed written consent on one's own)

- Sex: either sex. Female of child-bearing potential will be eligible for inclusion in

this study. However they have to have a negative pregnancy test at the screening visit, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the screening visit until the end of the follow-up examination.

Abstinence Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal

agent (foam /gel / film / cream / suppositor) - Both inpatient and outpatient status

Inclusion Criteria at the start of the non-inferiority verification phase

- Patients whose UPDRS PartIII total (on) scores is 10 points or more at week 0

Exclusion Criteria:

- Late stage advanced subjects demonstrating incapacitating peak dose or biphasic

dyskinsia on their stable dose of L-dopa.

- Patients who present serious physical signs and symptoms other than those of the PD

(e. g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (PAB/SD Notification No. 80, dated 29 June 1992).

- Patients with symptomatic postural hypotension. (e. g. dizziness and syncope).

- Patients with a current or history of drug abuse or alcoholism.

- Patients who have received surgical treatment for PD in the past (e. g. pallidectomy,

deep brain stimulation).

- Female patients who are pregnant or lactating, who may be pregnant, or who plan for

pregnancy during the study or within 30 days after the last dose of the study drug.

- Patients with chronic hepatitis typeB and/or type C which is positive of hepatitis B

surface antigen (HBsAg) and/or hepatitis C antibody.

- Patients with a history of drug allergy to ropinirole HCl.

- Patients with a current or history of cancer or malignant tumor

- Others whom the investigator (subinvestigator) considers ineligible for the study.

Exclusion criteria at the start of the non-inferiority verification phase

- Patients with severe dementia (e. g. score 3 or 4 of the UPDRS item 1 (Intellectual

Impairment))

- Patients with current or history of major psychosis (e. g. schizophrenia or psychotic

depression) core 3 or 4 of the UPDRS item 2 (thought disorder) or item 3(depression)

- Patients who have used any dopamine agonist within 4 weeks prior to the

non-inferiority verification phase

- Patients who have been treated with the following drugs at 4 weeks or earlier before

the start of the non-inferiority verification phase, and whose treatment regimen of the drug has been changed. Anticolinergic agents: trihexyphenidyl hydrochloride (e. g. Artane®), piroheptine hydrochloride (Trimol®), mazaticol hydrochloride (Pentona®), metixene hydrochloride (Cholinfall®), biperiden hydrochloride (Akineton®), profenamine (Parkin®), amantadine hydrochloride (e. g. Symmetrel®),droxidopa (Dops®), citicoline (e. g. Nicholin®), selegiline hydrochloride (FP®), entacapone, (comutan®) zonisamide, Estrogens: e. g. estriol (e. g. Estriel®), CYP1A2 inhibitors: Ciprofloxacin HCl (e. g. Ciproxan®, enoxacin and fluvoxamine)

- Patients who have been treated with any other investigational drug within 12 weeks

prior to the treatment phase

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Hyogo 670-0981, Japan; Recruiting

GSK Investigational Site, Akita 010-0874, Japan; Recruiting

GSK Investigational Site, Tokyo 202-0004, Japan; Recruiting

GSK Investigational Site, Aichi 460-0008, Japan; Recruiting

GSK Investigational Site, Fukuoka 819-8585, Japan; Recruiting

GSK Investigational Site, Hyogo 674-0081, Japan; Recruiting

GSK Investigational Site, Chiba 270-1337, Japan; Recruiting

GSK Investigational Site, Osaka 590-0132, Japan; Recruiting

GSK Investigational Site, Kanagawa 251-0038, Japan; Recruiting

GSK Investigational Site, Kyoto 600-8811, Japan; Recruiting

GSK Investigational Site, Aichi 465-8620, Japan; Recruiting

GSK Investigational Site, Fukushima 963-8052, Japan; Recruiting

GSK Investigational Site, Ehime 791-0204, Japan; Recruiting

GSK Investigational Site, Hokkaido 068-0027, Japan; Recruiting

GSK Investigational Site, Osaka 596-8522, Japan; Recruiting

GSK Investigational Site, Shiga 524-0022, Japan; Recruiting

GSK Investigational Site, Fukuoka 800-0296, Japan; Recruiting

GSK Investigational Site, Shizuoka 420-8688, Japan; Recruiting

GSK Investigational Site, Osaka 598-0048, Japan; Recruiting

GSK Investigational Site, Fukuoka 814-0180, Japan; Recruiting

GSK Investigational Site, Osaka 530-8480, Japan; Recruiting

GSK Investigational Site, Tokyo 113-0033, Japan; Recruiting

GSK Investigational Site, Miyagi 983-8520, Japan; Recruiting

GSK Investigational Site, Chiba 290-0003, Japan; Recruiting

GSK Investigational Site, Kyoto 616-8255, Japan; Recruiting

GSK Investigational Site, Chiba 279-0021, Japan; Recruiting

GSK Investigational Site, Nagano 399-8695, Japan; Recruiting

GSK Investigational Site, Saitama 359-1141, Japan; Recruiting

GSK Investigational Site, Shizuoka 416-0955, Japan; Recruiting

GSK Investigational Site, Kyoto 601-1495, Japan; Recruiting

GSK Investigational Site, Aichi 454-0933, Japan; Recruiting

GSK Investigational Site, Osaka 570-8507, Japan; Recruiting

GSK Investigational Site, Kanagawa 228-8522, Japan; Recruiting

GSK Investigational Site, Kanagawa 253-8558, Japan; Recruiting

GSK Investigational Site, Nagasaki 859-3615, Japan; Recruiting

GSK Investigational Site, Tokyo 136-0075, Japan; Recruiting

GSK Investigational Site, Chiba 260-8712, Japan; Recruiting

GSK Investigational Site, Hyogo 651-2273, Japan; Recruiting

GSK Investigational Site, Tochigi 329-0498, Japan; Not yet recruiting

GSK Investigational Site, Chiba 270-2251, Japan; Recruiting

GSK Investigational Site, Aichi 489-8642, Japan; Recruiting

GSK Investigational Site, Tokyo 183-8524, Japan; Recruiting

GSK Investigational Site, Saitama 343-0032, Japan; Recruiting

GSK Investigational Site, Osaka 543-8555, Japan; Recruiting

GSK Investigational Site, Kanagawa 232-0066, Japan; Recruiting

GSK Investigational Site, Nara 632-8552, Japan; Recruiting

GSK Investigational Site, Okayama 703-8265, Japan; Recruiting

GSK Investigational Site, Kanagawa 247-8533, Japan; Recruiting

GSK Investigational Site, Fukuoka 816-0864, Japan; Recruiting

GSK Investigational Site, Kyoto 610-0113, Japan; Not yet recruiting

GSK Investigational Site, Osaka 560-8522, Japan; Not yet recruiting

GSK Investigational Site, Nagano 399-0157, Japan; Recruiting

GSK Investigational Site, Osaka 578-8588, Japan; Recruiting

GSK Investigational Site, Ibaraki 310-0011, Japan; Recruiting

Starting date: March 2009
Ending date: February 2011
Last updated: October 8, 2009