Official Title: “Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - <Clinical Pharmacology / Exploratory Study>”

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

Study Type: Interventional

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

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: SK&F106064 (Ropinirole)

Primary Measures

• 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
  • Time Frame: 24 Hours
    

Secondary Measures

• Adverse events and Change from baseline in the Japanese UPDRS motor score in Part III (motor scores) at Week 16
  • Time Frame: 16 Weeks
    
• 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.
• <Rationale for the exclusion criteria> 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.

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.
• <Rationale for the exclusion criteria>
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00434304

Study ID Number: ROP106064

ClinicalTrials.gov Identifier: NCT00434304

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency