REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

NCT00485069 | Completed Phase 4 Results

• 1 other identifier: 108862
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 22

Brief Summary

Ropinirole Hydrochloride (ROP) was granted approval for the treatment of Parkinson's Disease (PD) on 20 October 2006. ROP is expected to be used for a long term in clinical practice. However, no long-term clinical data with ROP administered three times daily are currently available from Japanese patients, and the clinical experience with ROP 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 (Japanese Unified Parkinson's Disease Rating Scale (UPDRS), Awake time spent "Off"/"On", Modified Hoehn \& Yahr stage, Schwab-England scale, Proportion of subjects remaining in this study and Clinical Global Impression (CGI)) and the long-term safety of ROP administered three times daily for in PD patients.

Conditions

Parkinson Disease; Parkinson's Disease

Keywords

Ropinirole hydrochloride; L-dopa; Parkinson's Disease; Dopamine agonist

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)

  The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. "On" state is where PD symptoms are well controlled by the drug. Participants with "off" state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with "off" state at Week 52 and those prematurely withdrawn were not included at Week 52.

  Baseline, Week 52, and FAP (up to Week 52)

Secondary Outcomes (22)

• Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP

  Baseline, Week 52, and FAP (up to Week 52)

• Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group

  Baseline, Week 52, and FAP (up to Week 52)

• Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group

  Baseline, Week 52, and FAP (up to Week 52)

• Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP

  Baseline, Week 52, and FAP (up to Week 52)

• Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP

  Baseline, Week 52, and FAP (up to Week 52)

Study Arms (1)

Ropinirole Hydrochloride

EXPERIMENTAL

Drug: ROP; Drug: ROP+L-Dopa

Interventions

ROP DRUG

Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study.

Ropinirole Hydrochloride

ROP+L-Dopa DRUG

Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.

Ropinirole Hydrochloride

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ROP.
• 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)
• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (22)

GSK Investigational Site

Chiba, 270-2251, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Fukuoka, 816-0943, Japan

Location

GSK Investigational Site

Fukuoka, 819-8585, Japan

Location

GSK Investigational Site

Hyōgo, 651-2273, Japan

Location

GSK Investigational Site

Ibaraki, 300-0053, Japan

Location

GSK Investigational Site

Kanagawa, 247-8533, Japan

Location

GSK Investigational Site

Kanagawa, 253-8558, Japan

Location

GSK Investigational Site

Kyoto, 616-8255, Japan

Location

GSK Investigational Site

Miyagi, 982-8555, Japan

Location

GSK Investigational Site

Miyagi, 989-2202, Japan

Location

GSK Investigational Site

Numakunai, 020-8505, Japan

Location

GSK Investigational Site

Osaka, 543-8555, Japan

Location

GSK Investigational Site

Osaka, 558-8558, Japan

Location

GSK Investigational Site

Osaka, 578-8588, Japan

Location

GSK Investigational Site

Osaka, 590-0132, Japan

Location

GSK Investigational Site

Osaka, 598-0048, Japan

Location

GSK Investigational Site

Saga, 849-8501, Japan

Location

GSK Investigational Site

Saitama, 364-8501, Japan

Location

GSK Investigational Site

Tokyo, 154-8551, Japan

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

GSK Investigational Site

Tokyo, 187-8551, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 12, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 15, 2010
• Results First Posted: December 15, 2010

Record last verified: 2010-11

Locations

JP (22)