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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00823836
Date of registration:	15/01/2009
Prospective Registration:	Yes
Primary sponsor:	GlaxoSmithKline
Public title:	Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
Scientific title:	Clinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
Date of first enrolment:	March 2009
Target sample size:	302
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00823836
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Japan

Contacts

Name:	GSK Clinical Trials
Address:
Telephone:
Email:
Affiliation:	GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

Inclusion criteria at the start of the screening

- Patients who are diagnosed with advanced Parkinson's disease (PD) with severity of the
modified Hoehn & Yahr criteria Stages II-IV.

- Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening
phase and demonstrating lack of control with L-dopa therapy in the following
circumstances. Wearing-off phenomena. On-off fluctuations. Delayed-on/No on phenomena.
Not adequately controlled on L-dopa

- QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block - values
based on either single ECG values or triplicate electrocardiogram (ECG) averaged QTc
values obtained over a brief recording period.

- Age:20 years or older(at the time of informed written consent)

- 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)

- Sex: either sex. Female of child-bearing potential will be eligible for inclusion in
this study. However they have to have a negative pregnancy test at the screening
visit, agree to further pregnancy testing at the time points determined in study
assessments and procedures and practice one of the following methods of contraception
from the screening visit until the end of the follow-up examination. Abstinence.
Injectable progestogen. Implants of levonorgestrel. Estrogenic vaginal ring.
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)

- Both inpatient and outpatient status.

Inclusion Criteria at the start of the non-inferiority verification phase

-Patients whose Unified Parkinson's Disease Rating Scale (UPDRS) PartIII total (on) scores
is 10 points or more at week 0.

Exclusion Criteria:

- Late stage advanced subjects demonstrating incapacitating peak dose or biphasic
dyskinesia on their stable dose of L-dopa.

- Patients who present serious physical signs and symptoms other than those of the PD
(e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers
to Grade 3 according to "the Classification of the Severity of Adverse Experiences
(Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29
June 1992).

- Patients with symptomatic postural hypotension. (e.g. dizziness and syncope).

- Patients with a current or history of drug abuse or alcoholism.

- Patients who have received surgical treatment for PD in the past (e.g. pallidectomy,
deep brain stimulation).

- 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 chronic hepatitis typeB and/or type C which is positive of hepatitis B
surface antigen (HBsAg) and/or hepatitis C antibody.

- Patients with a history of drug allergy to ropinirole hydrochloride (HCl).

- Patients with a current or history of cancer or malignant tumor.

- Others whom the investigator (subinvestigator) considers ineligible for the study.

Exclusion criteria at the start of the non-inferiority verification phase

- Patients with severe dementia (e.g. score 3 or 4 of the UPDRS item 1 (Intellectual
Impairment))

- Patients with current or history of major psychosis (e.g. schizophrenia or psychotic
depression) core 3 or 4 of the UPDRS item 2 (thought disorder) or item 3(depression).

- Patients who have used any dopamine agonist within 4 weeks prior to the
non-inferiority verification phase

- Patients who have been treated with the following drugs at 4 weeks or earlier before
the start of the non-inferiority verification phase, and whose treatment regimen of
the drug has been changed. 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®), entacapone, (comutan®) zonisamide,
Estrogens: e.g. estriol (e.g. Estriel®), CYP1A2 inhibitors: Ciprofloxacin HCl (e.g.
Ciproxan®, enoxacin and fluvoxamine).

- Patients who have been treated with any other investigational drug within 12 weeks
prior to the treatment phase.

Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: ropinirole IR

Drug: ropinirole PR/XR

Primary Outcome(s)

Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Secondary Outcome(s)

Japanese UPDRS Part II (at "On") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 0 in Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 24 in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group [Time Frame: 0-175 days (up to Week 24)]

Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Week 54]

Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in Percentage of Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Japanese UPDRS Part II (at "Off") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Japanese UPDRS Part II (at "On") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 24 in the Japanese UPDRS Part II (at "On") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: 0-175 days (up to Week 24)]

Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: FAP (up to Week 24)]

Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Japanese UPDRS Part II (at "Off") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Japanese UPDRS Part II (at "Off") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Percentage of Responders in Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Week 54]

Japanese UPDRS Part II (at "On") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 24 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group [Time Frame: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)]

Percentage of Responders in Percent Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase [Time Frame: Week 54]

Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: FAP (up to Week 24)]

Mean Percent Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 24 in Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Mean Change From Week 24 in Percentage of Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Percentage of Responders in Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: FAP (up to Week 24)]

Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Mean Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in Percentage of Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Weeks 0 and 54]

Mean Change From Week 24 in the Japanese UPDRS Part II (at "Off") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: Week 0 and FAP (up to Week 24)]

Percentage of Responders in Percent Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase [Time Frame: FAP (up to Week 24)]

Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase [Time Frame: Week 24 and FAP (from Week 26 up to Week 32)]

Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: 0-385 days (up to Week 54)]

Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)]

Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group [Time Frame: Week 54]

Secondary ID(s)

106066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	07/10/2011
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00823836

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