Last updated: 02/03/2020 18:20:18
Efficacy of ropinirole controlled-release on the motor symptoms in advanced Parkinson’s disease patients: A post-hoc analysis of Japanese phase III clinical trial (Study ID: 201929)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Efficacy of ropinirole controlled-release on the motor symptoms in advanced Parkinson’s disease patients: A post-hoc analysis of Japanese phase III clinical trial (Study ID: 201929)
Trial description: The objectives of this study are to demonstrate efficacy of ropinirole controlled-release (CR) on each of cardinal motor symptoms such as tremor and rigidity in advanced Parkinson’s disease patient; and to assess the relationship between final doses of ropinirole CR at Week 24 and patient demographics/characteristics at baseline.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
UPDRS Part II and III
Timeframe: 0-24 weeks
Secondary outcomes:
Ropinirole CR dose and patient demographics/characteristics
Timeframe: 0-24 weeks
UPDRS, ropinirole CR dose, and proportion of patients
Timeframe: 0-24 weeks
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2015-04-02
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Nobutaka Hattori , Hirofumi Ozeki , Kazuko Hasegawa . Efficacy of ropinirole controlled-release on the motor symptoms such as tremor and rigidity in advanced Parkinson's disease patients: A post-hoc analysis of Japanese phase III clinical trial. J Clin Therapeut Med. 2015;31(7):735-741.
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
January 2015 to February 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
none
- N/A
- N/A
- Since this study is an additional analysis using data of ROP106066, no subjects are recruited.
Inclusion and exclusion criteria
Inclusion criteria:
- N/A
Exclusion criteria:
- N/A Since this study is an additional analysis using data of ROP106066, no subjects are recruited.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2015-04-02
Actual study completion date
2015-04-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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