Clinical trial NCT00485069: REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study
Official title: Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Parkinson's Disease
Keywords: Ropinirole hydrochloride
L-dopa
Parkinson's Disease
Dopamine agonist
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-12
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 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)
* 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.

* 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 ROP tablets.
* 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
Secondary outcomes:
measure: Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: 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
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Percent 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
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
timeFrame: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group
measure: Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
measure: Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group
timeFrame: Days 0-422
measure: Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group
timeFrame: Days 0-419
measure: Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP
timeFrame: Week 52 and FAP (up to Week 52)
measure: Mean Change From Baseline in Awake Time "Off" (Hours) and Awake Time "On" (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With "0" Off (Hour) at Baseline
timeFrame: Baseline, Week 52, and FAP (up to Week 52)
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Iwate
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Miyagi
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Saga
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: