Last updated: 11/07/2018 10:26:19
Sleepiness and mood in Parkinson's disease and combination treatment with ropinirole and levodopa
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Sleepiness and mood in Parkinson's disease and combination treatment with ropinirole and levodopa
Trial description: Cross sectional study
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean score of Epworth Sleepiness Scale
Timeframe: NA(cross sectional)
Secondary outcomes:
Mean scores of Geriatric Depression scale 30
Timeframe: cross sectional
Mean score of UPDRS Part II, III and total II+III
Timeframe: cross sectional
Proportion of subjects with motor fluctuation
Timeframe: cross sectional
Proportion of subjects with dyskinesia
Timeframe: cross sectional
Baseline factors affecting ESS and/or GDS 30
Timeframe: cross sectional
Factors affecting difference of UPDRS II, III and total II+III
Timeframe: cross sectional
The mean scores of GDS 30, ESS, UPDRS of whom with the same LED value and its variation according to the dosage of ropinirole
Timeframe: cross sectional
Interventions:
Enrollment:
462
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Cross-sectional
Clinical publications:
Suk Yun Kang, Ho-Sung Ryu, Mun-Kyung Sunwoo, Sang-Jin Kim, Jong-Sam Baik, Mee-Young Park, Hyung-Eun Park, Joong-Seok Kim, Kyum-Yil Kwon, Seong-Beom Koh, Young-Eun Kim, Mi-Kyong Lee, Jong-Min Kim, Sun-Ju Chung, Young-Ho Sohn. Sleepiness and depression in Parkinson’s disease patients treated with ropinirole and levodopa. J Movement Disord. 2017;10(3):123-129
Medical condition
Parkinson Disease
Product
levodopa, ropinirole
Collaborators
Not applicable
Study date(s)
May 2013 to March 2015
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- Subject who has been diagnosed with idiopathic parkinson’s disease
- Subject who has been treated with ropinirole and levodopa and other antiparkinsons over recent 6 months
- Patients with dementia corresponding to DSM-â…Ł criteria
- Patients currently participating in another clinical study
Inclusion and exclusion criteria
Inclusion criteria:
- Subject who has been diagnosed with idiopathic parkinson’s disease -Subject who has been treated with ropinirole and levodopa and other antiparkinsons over recent 6 months -Subject who has no change in dosage of ropinirole and levodopa in recent 1 month -Subject who has given informed consent for the use of information
Exclusion criteria:
- Patients with dementia corresponding to DSM-â…Ł criteria -Patients currently participating in another clinical study -Patients with chronic use of sedatives or hypnotics or with alcohol abuse -Patients with a serious disease that may affect sleep (e.g.,COPD, ischemic heart failure, stroke, painful joint disease, etc.) -Patients who has been treated with pramipexole in recent 6 months
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
Not applicable
Actual study completion date
2015-30-03
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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Access to clinical trial data by researchers
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