N/A

JRCT ID: jRCTs031180248

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 29/05/2019
• Target sample size: 111
• Study type: Interventional

Intervention(s)

Arm with treatment of Istradefylline and levodopa
Treatment with Istradefylline will be started at a dose of
20 mg administered once daily at Week 0. The dose of
Istradefylline will be increased to 40 mg once daily if
the patient has no tolerability issues and still has motor
symptoms at Week 1. Dose reduction is possible if the
patient has tolerability issues.
Patients will visit every 4 weeks from the following day
of Week0, and 50mg levodopa will be added of if CGI-S score
>=4 every time. Dose reduction is possible if the patient
has tolerability issues.
Arm without treatment of Istradefylline
50mg levodopa will be added at Week 0. Patients will visit
every 4 weeks from the following day of Week0, and 50mg
levodopa will be added of if CGI-S score >=4 every time.
Dose reduction is possible if the patient has tolerability
issues.

Outcome(s)

• Primary Outcome: Accumulated dose of Levodopa

Secondary Outcome

Additional dose of every time points after Week4 until Week36
Number of the days to the first additional dose from Week0
Change in the dose of levodopa until Week36
CGS-S score and change in CGS-S
CGS-I score from the previous visit
PGS-S score and change in PGS-S
PGS-I score from the previous visit
Change in modified Hoehn & Yahr scale
Movement Disorder Society-Unified Parkinson's Disease
Rating Scale (MDS-UPDRS) Part1,2,3,4 score and total score
Change in Movement Disorder Society-Unified Parkinson's
Disease Rating Scale (MDS-UPDRS) Part1,2,3,4 score and
total score
Change in Parkinson's Disease Questionnaire (PDQ)-39 score
Correlation among the score change presented
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

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 84age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Hatano Taku
• Secondary Sponsor: Kyowa Kirin Co., Ltd