/A
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCTs031180248
- Lead Sponsor
- Hatano Taku
- Brief Summary
The accumulated additional dose of levodopacontaining drugs in the IST-treated group was approximately 5 times lower than that in the ISTuntreated group, indicating a statistically significant difference. In objective exercise assessment using wearable devices, only the IST-treated group showed a significant improvement at Week 36, compared with Week 0. This study clarified the effectiveness of adjunctive IST compared with increase dose of levodopa-containing drugs in PD patients with wearing-off.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 105
1) Current use of levodopa-containing drugs more than
300mg/day and less than 400mg/day administered at least
three times daily
2) Patients with wearing-off
3) >= 30 to < 85 years of age at the time of registration
for the study
4) Diagnosed as Parkinson's disease based on the
International Parkinson and Movement Disorder Society
(MDS)
5) Stages <=3 in the ON state for Modified Hoehn and Yahr
Scale
6) Patients who have given written consent if the patient
has difficulty in writing due to his or her condition,
a representative may sign the written consent, subject
to the patient's prior oral consent
1) Use of Istradefylline in the past
2) Current use of an investigational drug (within 4 months
prior to the registration for the study)
3) Patients with dementia or a score of 23 or less on the
Mini-Mental State Examination (MMSE)
4) Patients with a previous history of brain surgery for
the treatment of Parkinson's disease at the time point
of the registration
5) Current use or plan to administer levodopa/carbidopa
intestinal gel at the time point of the registration
6) Patients with moderate to severe hepatic disorder
7)Use of a new anti-Parkinson's disease drugs or change
in the treatment of anti-Parkinson's disease drugs
within 14 days prior to the registration for the study
8) Current use of a strong inhibitor of CYP3A4
(Itraconazole, Clarithromycin) within 14days prior to
the registration of the study
9) Female patients who are pregnant, trying to become
pregnant or nursing (lactating) an infant
10) Patients who are in the Investigator's judgment
unlikely to comply with medical regimens or study
requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accumulated dose of Levodopa
- Secondary Outcome Measures
Name Time Method Additional dose of every time points after Week4 until Week36<br>Number of the days to the first additional dose from Week0<br>Change in the dose of levodopa until Week36<br>CGS-S score and change in CGS-S<br>CGS-I score from the previous visit<br>PGS-S score and change in PGS-S<br>PGS-I score from the previous visit<br>Change in modified Hoehn & Yahr scale<br>Movement Disorder Society-Unified Parkinson's Disease<br>Rating Scale (MDS-UPDRS) Part1,2,3,4 score and total score<br>Change in Movement Disorder Society-Unified Parkinson's<br>Disease Rating Scale (MDS-UPDRS) Part1,2,3,4 score and<br>total score<br>Change in Parkinson's Disease Questionnaire (PDQ)-39 score<br>Correlation among the score change presented<br>Analysis of the motion (frequency, strength), gait(counts,pitch, balance), sleeping (bedtime, Wake-up time, time of sleeping, sleep efficiency, sleep onset latency, frequency and intensity of physical activity during sleep, total time of bed-leaving, REM/Non-REM) using wearable device