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

NCT00434304 | Completed Phase 2 Results

• 1 other identifier: ROP106064
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; PD

Outcome Measures

Primary Outcomes (4)

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

  The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.

  Weeks 5-16

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

  The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.

  Weeks 5-16

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

  The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.

  Weeks 5-16

• Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites

  Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.

  Weeks 1-16

Secondary Outcomes (28)

• Total Score in the Japanese UPDRS Part III

  Weeks 0-52

• Change From Baseline in the Japanese UPDRS Part III

  Baseline (Week 0) and Weeks 1-52

• Percent Change From Baseline in the Japanese UPDRS Part III

  Baseline (Week 0) and Weeks 1-52

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

  Baseline (Week 0) and Weeks 1-52

• Total Score in the Japanese UPDRS Part I

  Weeks 0-52

Study Arms (1)

Ropinirole PR/XR

EXPERIMENTAL

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

Interventions

Ropinirole prolonged release/extended release(PR/XR) DRUG

Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).

Ropinirole PR/XR

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Aichi, 455-8530, Japan

Location

GSK Investigational Site

Aichi, 460-0008, Japan

Location

GSK Investigational Site

Chiba, 279-0021, Japan

Location

GSK Investigational Site

Ehime, 791-0295, Japan

Location

GSK Investigational Site

Hokkaido, 070-0901, Japan

Location

GSK Investigational Site

Kanagawa, 251-0038, Japan

Location

GSK Investigational Site

Kyoto, 600-8811, Japan

Location

GSK Investigational Site

Numakunai, 020-0878, Japan

Location

GSK Investigational Site

Osaka, 570-8507, Japan

Location

GSK Investigational Site

Saitama, 343-0032, Japan

Location

GSK Investigational Site

Tokyo, 113-8431, Japan

Location

GSK Investigational Site

Tokyo, 136-0075, 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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 13, 2007
• Study Start: April 9, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 10, 2009
• Last Updated: September 27, 2018
• Results First Posted: December 23, 2009

Record last verified: 2018-08

Locations

JP (12)