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Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: Ropinirole prolonged release/extended release(PR/XR) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

Official title: Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites

Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites

Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites

Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites

Secondary outcome:

Total Score in the Japanese UPDRS Part III

Change From Baseline in the Japanese UPDRS Part III

Percent Change From Baseline in the Japanese UPDRS Part III

Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III

Total Score in the Japanese UPDRS Part I

Change From Baseline in the Japanese UPDRS Part I

Percent Change From Baseline in the Japanese UPDRS Part I

Total Score in the Japanese UPDRS Part II

Change From Baseline in the Japanese UPDRS Part II

Percent Change From Baseline in the Japanese UPDRS Part II

Total Score in the Japanese UPDRS Part IV

Change From Baseline in the Japanese UPDRS Part IV

Percent Change From Baseline in the Japanese UPDRS Part IV

Summary of the Modified Hoehn & Yahr Criteria Stages

Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale

Percentage of Participants Who Remained in the Study on the Indicated Days

Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52

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

Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52

Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52

Change From Baseline in Prolactin at Weeks 16 and 52

Change From Baseline in Hematocrit at Weeks 16 and 52

Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52

Change From Baseline in Red Blood Cell Count at Weeks 16 and 52

Urinalysis Data

Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52

Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52

Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: April 2007
Last updated: April 11, 2013

Page last updated: August 23, 2015

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