Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

Condition(s) targeted: Parkinson's Disease

Intervention: SK&F106064 (Ropinirole) (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: GlaxoSmithKline

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

This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.

Official title: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: AUC, Cmax and tmax in the fed and fasted state up to 24-hour post dose in the Maintenance phase and through concentration (Cmin) and in the fixed titration phase at 24-hour post dose of the last dose of 2, 4, and 8mg dose administration

Secondary outcome:

Adverse events and Change from baseline in the Japanese UPDRS motor score in Part III (motor scores) at Week 16

Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The seriousness 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 who have had serious psychiatric symptoms (e.g. confusion, hallucination, delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-Parkinson drugs).

Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week -4 to Week 0.

• Anticholinergic 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®) zonisamide estrogen: estriol (e.g.Estriel®)

CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine)

Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation, behaviour, and mood)

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 current history or complication of carcinoma or malignant tumour. Patients who have history of drug allergy to ropinirole HCl.

Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation).

Patients who have been treated with any other investigational drug within 12 weeks prior to the treatment phase. Others whom the investigator (sub investigator) considers ineligible for the study.

1. This criterion is included to secure the safety of subjects.

This criterion is required since ropinirole HCl may possibly cause decrease of heart rate from its mechanism of action. This criterion is included to secure the safety of subjects.

This criterion is necessary to evaluate the efficacy and safety of ropinirole HCl appropriately and to secure the safety of subjects. This criterion is necessary to evaluate the efficacy and safety of ropinirole HCl appropriately.

This criterion is necessary because the safety of use in pregnant female and developing foetuses has not been established, and studies in rats have shown that there is some evidence of toxicity to the foetuses

(weight loss, increased mortality, and digit malformation), and that ropinirole HCl is excreted in milk.

This criterion is necessary to evaluate the safety of ropinirole HCl appropriately, and to secure the safety of subjects. This criterion is necessary to evaluate the safety of ropinirole HCl appropriately, and to secure the safety of subjects.

This criterion is necessary to evaluate the efficacy and safety of ropinirole HCl appropriately. This criterion is necessary to evaluate the safety and efficacy of ropinirole HCl appropriately, and to secure the safety of subjects.

This criterion is necessary to evaluate the safety and efficacy of ropinirole HCl appropriately, and to secure the safety of subjects.

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

Criteria:

Inclusion Criteria:

- Patients who are diagnosed with PD with severity of the Modified Hoehn & Yahr staging

at Stage I to III.

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

- Gender: male and female

- Both inpatient and outpatient status

- 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)

- Limited prior exposure to low or moderate doses of L-dopa (up to 3 months in total) or

dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 42 weeks prior to screening.

Exclusion Criteria:

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

(e. g. cardiac/hepatic/renal disorder and haematopoietic disorder).

The seriousness 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 who have had serious psychiatric symptoms (e. g. confusion, hallucination,

delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-Parkinson drugs).

- Patients who have been treated with the following drugs at Week -4, and whose

treatment regimen of the drug has been changed from Week-4 to Week0.

- Anticholinergic 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®)

- zonisamide

- estrogen: estriol (e. g.Estriel®)

- CYP1A2 inhibitors: Ciprofloxacin HCl (e. g. Ciproxan®, enoxacin and fluvoxamine)

- Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation,

behaviour, and mood)

- 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 current history or complication of carcinoma or malignant tumour.

- Patients who have history of drug allergy to ropinirole HCl.

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

deep brain stimulation).

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

- weeks prior to the treatment phase.

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

- This criterion is included to secure the safety of subjects.

- This criterion is required since ropinirole HCl may possibly cause decrease of heart

rate from its mechanism of action.

- This criterion is included to secure the safety of subjects.

- This criterion is necessary to evaluate the efficacy and safety of ropinirole HCl

appropriately and to secure the safety of subjects.

- This criterion is necessary to evaluate the efficacy and safety of ropinirole HCl

appropriately.

- This criterion is necessary because the safety of use in pregnant female and

developing foetuses has not been established, and studies in rats have shown that there is some evidence of toxicity to the foetuses (weight loss, increased mortality, and digit malformation), and that ropinirole HCl is excreted in milk.

- This criterion is necessary to evaluate the safety of ropinirole HCl appropriately,

and to secure the safety of subjects.

- This criterion is necessary to evaluate the safety of ropinirole HCl appropriately,

and to secure the safety of subjects.

- This criterion is necessary to evaluate the efficacy and safety of ropinirole HCl

appropriately.

- This criterion is necessary to evaluate the safety and efficacy of ropinirole HCl

appropriately, and to secure the safety of subjects.

- This criterion is necessary to evaluate the safety and efficacy of ropinirole HCl

appropriately, and to secure the safety of subjects.

GSK Clinical Trials Call Center, Kyoto city 600, Japan; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718

GSK Clinical Trials Call Center, Fujisawa-city 251, Japan; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718

GSK Clinical Trials Call Center, Morioka-city 020, Japan; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718

GSK Clinical Trials Call Center, Nagoya-city 460, Japan; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718

GSK Clinical Trials Call Centrer, Nagoya-city 455, Japan; Recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718

Starting date: August 2007
Ending date: May 2009
Last updated: March 19, 2008