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Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
This study is ongoing, but not recruiting participants.
First Received: February 9, 2007   Last Updated: January 8, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00434304
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Drug: SK&F106064 (Ropinirole)
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - <Clinical Pharmacology / Exploratory Study>

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 Outcome Measures:
  • 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.
  • 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)
  • 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.
  • 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.

Estimated Enrollment: 60
Study Start Date: April 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

<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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434304

Locations
Japan
GSK Investigational Site
Aichi, Japan, 455-0018
GSK Investigational Site
Chiba, Japan, 279-0021
GSK Investigational Site
Hokkaido, Japan, 070-0901
GSK Investigational Site
Kyoto, Japan, 600-8811
GSK Investigational Site
Aichi, Japan, 460-0008
GSK Investigational Site
Kanagawa, Japan, 251-0038
GSK Investigational Site
Tokyo, Japan, 136-0075
GSK Investigational Site
Osaka, Japan, 570-8507
GSK Investigational Site
Tokyo, Japan, 113-0033
GSK Investigational Site
Iwate, Japan, 020-0878
GSK Investigational Site
Ehime, Japan, 791-0204
GSK Investigational Site
Saitama, Japan, 343-0032
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: ROP106064
Study First Received: February 9, 2007
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00434304     History of Changes
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency;   Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
PD
Parkinson's Disease

Study placed in the following topic categories:
Ropinirole
Neurotransmitter Agents
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dopamine Agonists
Dopamine
Parkinson Disease
Movement Disorders
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009