Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01536574
First received: January 19, 2012
Last updated: November 15, 2012
Last verified: October 2012
  Purpose

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.

Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.

Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.


Condition Intervention Phase
Parkinson Disease
Drug: Requip PR
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) [ Time Frame: From the start of treatment (Baseline) up to Week 25 ] [ Designated as safety issue: Yes ]
    AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.

  • Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase [ Time Frame: From the start of treatment (Baseline) up to Week 25 ] [ Designated as safety issue: Yes ]
    An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.

  • Number of Participants With an Adverse Event During the Follow-up Phase [ Time Frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) ] [ Designated as safety issue: Yes ]
    AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.

  • Number of Participants With the Indicated Adverse Events During the Follow-up Phase [ Time Frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) ] [ Designated as safety issue: Yes ]
    An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.

  • Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase [ Time Frame: 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) ] [ Designated as safety issue: Yes ]
    An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.


Secondary Outcome Measures:
  • Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe.

  • Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.


Enrollment: 295
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Requip PR
Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg
Drug: Requip PR
Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have completed 24 weeks of randomised treatment in study ROP111528(and must have completed the one-week downtitration at the end of treatment/early withdrawal).
  2. Subjects must not have a break in medication between completing the downtitration phase for studies ROP111528 and beginning treatment in this extension study.
  3. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System).
  4. Provide written informed consent for this study.
  5. Be willing and able to comply with study procedures.

Exclusion Criteria:

  1. Patients with any ongoing clinically significant adverse events at the end of the study ROP111528.
  2. Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
  3. Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the study ROP111528.
  4. Subjects with severe dizziness or fainting due to postural hypotension on standing.
  5. Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
  6. Women who are pregnant or breast-feeding.
  7. Use of an investigational drug throughout the treatment period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536574

Locations
China, Hubei
GSK Investigational Site
Wuhan, Hubei, China, 430022
China, Jiangsu
GSK Investigational Site
Suzhou, Jiangsu, China, 215004
China, Shaanxi
GSK Investigational Site
Xian, Shaanxi, China, 710061
China, Sichuan
GSK Investigational Site
Chengdu, Sichuan, China, 610041
China, Yunnan
GSK Investigational Site
Kunming, Yunnan, China, 650032
GSK Investigational Site
Kunming, Yunnan, China, 650101
China, Zhejiang
GSK Investigational Site
Hangzhou, Zhejiang, China, 310009
China
GSK Investigational Site
Beijing, China, 100050
GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Beijing, China, 100730
GSK Investigational Site
Beijing, China, 100853
GSK Investigational Site
Beijing, China, 100053
GSK Investigational Site
Shanghai, China, 200032
GSK Investigational Site
Shanghai, China, 200040
GSK Investigational Site
Shanghai, China, 200025
GSK Investigational Site
Tianjin, China, 300052
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01536574     History of Changes
Other Study ID Numbers: 114463
Study First Received: January 19, 2012
Results First Received: November 15, 2012
Last Updated: November 15, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014