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REQUIP (Ropinirole Hydrochloride)IR Long-Term Phase 4 Study
This study is currently recruiting participants.
Verified by GlaxoSmithKline, October 2008
First Received: June 11, 2007   Last Updated: October 16, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00485069
  Purpose

REQUIP was granted approval for the treatment of Parkinson's Disease on 20 October 2006.

REQUIP is expected to be used for a long term in clinical practice. However, no long-term clinical data with REQUIP administered three times daily are currently available from Japanese patients, and the clinical experience with REQUIP at >10mg/day is limited.

For this reason, this study was designed as a multicenter open-label uncontrolled study.

This study will evaluate the long-term efficacy (UPDRS, Awake time spent "Off"/"On", Modified Hoehn & Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and CGI) and the long-term safety of REQUIP administered three times daily for in Parkinson's Disease patients.


Condition Intervention Phase
Parkinson's Disease
Drug: ropinirole hydrochloride
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Post-Marketing Clinical Study of REQUIP Tablets in Patients With Parkinson's Disease - Evaluation of Long-Term Efficacy and Safety -

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Efficacy <Adjunct Therapy Group (REQUIP+L-dopa)> - Change from baseline in Japanese UPDRS Part III total score (recorded in an "on" state) <Monotherapy Group (REQUIP alone)> - Change from baseline in Japanese UPDRS Part III total score

Secondary Outcome Measures:
  • Safety - Adverse events: type, severity and frequency - Clinical laboratory tests (hematology, clinical chemistry) - ECG (standard 12-lead ECG) - Vital signs (blood pressure, pulse rate)

Estimated Enrollment: 100
Study Start Date: June 2007
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (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:

Subjects eligible for enrollment in the study must meet all of the following criteria. Note that both inpatients and outpatients are eligible.

  • Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn & Yahr Stages I to IV.
  • Patients who have been receiving another dopamine agonist for at least 4 weeks prior to the start of the screening phase and are expected to benefit from conversion to ReQuip.
  • Age: 20 years (at the time of written informed consent).
  • Informed consent: Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own).
  • Gender: Male or female Females of childbearing potential are eligible for enrollment in the study, only if the subject has a negative pregnancy test at the start of the screening phase and agrees to conduct pregnancy testing at the protocol-specified visits during the study and use one of the following acceptable methods of contraceptions properly and accurately:

    • Abstinence
    • Oral contraceptive, either combined or progestogen alone
    • Injectable progestogen
    • Implants of levonorgestrel
    • Estrogenic vaginal ring (Caution: This should be used cautiously, because the blood concentration of the study drug may be increased.)
    • 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/suppository)

Exclusion criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

  • Patients who present with any serious medical condition other than PD (e.g., cardiac, hepatic or renal disorder or hematopoietic disorder).

Serious is defined as Grade 3 as a rule according to the Classification of the Severity of Adverse Experiences (PAB/SD Notification No. 80, dated 29 June 1992) .

  • Patients with postural hypotension with any subjective symptoms (e.g., dizziness and syncope).
  • Patients who have had any serious psychiatric symptoms (e.g., confusion, hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD drugs) within 6 months (26 weeks) prior to written informed consent.
  • Patients who have initiated any of the following drugs within 4 weeks of the start of the screening phase and have the dosing regimen of the drug changed within 4 weeks of the start of the screening phase.

    • L-dopa (+DCI) (NOTE: This does not apply to the monotherapy group.)
    • Anticholinergic agents: trihexyphenidyl hydrochloride, piroheptine hydrochloride, mazaticol hydrochloride, metixene hydrochloride, biperiden, profenamine
    • amantadine hydrochloride
    • droxidopa
    • citicoline
    • selegiline hydrochloride
    • entacapone
    • zonisamide
  • Patients with severe dementia with a Japanese UPDRS Part I (mentation, behavior, and mood) score of 3 or 4.
  • Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study period or within 30 days after the last dose of the study drug.
  • Patients with a history of drug allergy to any ingredients of ReQuip.
  • 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 product within 12 weeks prior to the start of the screening phase.
  • Patients who, in the judgement of the investigator (or sub-investigator), have evidence of alcohol or drug abuse.
  • Others whom the investigator (or sub-investigator) considers ineligible for the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485069

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Japan
GSK Investigational Site Recruiting
Iwate, Japan, 020-8505
GSK Investigational Site Recruiting
Tokyo, Japan, 160-0017
GSK Investigational Site Recruiting
Hyogo, Japan, 651-2273
GSK Investigational Site Recruiting
Saitama, Japan, 364-8501
GSK Investigational Site Recruiting
Miyagi, Japan, 982-8555
GSK Investigational Site Recruiting
Kanagawa, Japan, 247-8533
GSK Investigational Site Recruiting
Kanagawa, Japan, 253-8558
GSK Investigational Site Recruiting
Osaka, Japan, 543-8555
GSK Investigational Site Recruiting
Tokyo, Japan, 187-8551
GSK Investigational Site Recruiting
Saga, Japan, 849-8501
GSK Investigational Site Recruiting
Osaka, Japan, 590-0132
GSK Investigational Site Recruiting
Chiba, Japan, 270-2251
GSK Investigational Site Withdrawn
Okayama, Japan, 710-0803
GSK Investigational Site Recruiting
Miyagi, Japan, 989-2202
GSK Investigational Site Recruiting
Kyoto, Japan, 616-8255
GSK Investigational Site Recruiting
Fukuoka, Japan, 819-8585
GSK Investigational Site Recruiting
Ibaraki, Japan, 300-0053
GSK Investigational Site Recruiting
Tokyo, Japan, 154-8551
GSK Investigational Site Recruiting
Osaka, Japan, 578-8588
GSK Investigational Site Recruiting
Osaka, Japan, 558-8558
GSK Investigational Site Recruiting
Fukuoka, Japan, 816-0943
GSK Investigational Site Withdrawn
Tokushima, Japan, 776-8585
GSK Investigational Site Withdrawn
Fukuoka, Japan, 802-0071
GSK Investigational Site Recruiting
Osaka, Japan, 598-0048
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: 108862
Study First Received: June 11, 2007
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00485069     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
REQUIP®
Parkinson's Disease
L-dopa
Dopamine agonist

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