Clinical trial NCT00434304: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
Official title: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
PD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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 4 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 (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 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)
* 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 hydrochloride (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 12weeks prior to the treatment phase.
* Others whom the investigator (sub investigator) considers ineligible for the study.

Primary outcomes:
measure: Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites
timeFrame: Weeks 5-16
measure: Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites
timeFrame: Weeks 5-16
measure: Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites
timeFrame: Weeks 5-16
measure: Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites
timeFrame: Weeks 1-16
Secondary outcomes:
measure: Total Score in the Japanese UPDRS Part III
timeFrame: Weeks 0-52
measure: Change From Baseline in the Japanese UPDRS Part III
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Percent Change From Baseline in the Japanese UPDRS Part III
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Total Score in the Japanese UPDRS Part I
timeFrame: Weeks 0-52
measure: Change From Baseline in the Japanese UPDRS Part I
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Percent Change From Baseline in the Japanese UPDRS Part I
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Total Score in the Japanese UPDRS Part II
timeFrame: Weeks 0-52
measure: Change From Baseline in the Japanese UPDRS Part II
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Percent Change From Baseline in the Japanese UPDRS Part II
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Total Score in the Japanese UPDRS Part IV
timeFrame: Baseline (Week 0) and Weeks 0-52
measure: Change From Baseline in the Japanese UPDRS Part IV
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Percent Change From Baseline in the Japanese UPDRS Part IV
timeFrame: Baseline (Week 0) and Weeks 1-52
measure: Summary of the Modified Hoehn & Yahr Criteria Stages
timeFrame: Screening-Week 52
measure: Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale
timeFrame: Weeks 1-52
measure: Percentage of Participants Who Remained in the Study on the Indicated Days
timeFrame: Days 0-364
measure: Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Prolactin at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Hematocrit at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Red Blood Cell Count at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Urinalysis Data
timeFrame: Screening, Week 16, and Week 52
measure: Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
measure: Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52
timeFrame: Baseline (Screening) and Weeks 16 and 52
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Ehime
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Iwate
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Osaka
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
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: