Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease

Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease - Long-term efficacy and safety of istradefylline for the treatment of advanced Parkinson's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021899

Enrollment

Registered

2016-04-13

Start date

2016-01-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&amp

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Parkinson's disease patients experiencing the "wearing off" phenomenon while receiving therapy with L-dopa preparations 2.Outpatients of clinical research centers who had been taking istradefylline for more than 12 months 3.Patients at least 20 years of age during the reporting period

Exclusion criteria

Exclusion criteria: 1.Patients with moderate or severe liver disorder or taking medications that strongly inhibit CYP3A4 2.Patients who are nursing or pregnant or might be pregnant 3.Patients in whom efficacy data were not collected at 6 and 12 months after oral treatment with istradefylline

Design outcomes

Primary

Measure	Time frame
UPDRS partIII(before treatment and at 3, 6 and 12 months after treatment)	—

Secondary

Measure	Time frame
off-time,UPDRS partII,CGI,BDI-II,JESS,MMSE,safety(before treatment and at 3, 6 and 12 months after treatment)	—

Countries

Japan

Contacts

Public ContactSayumi Hasegawa

QOL RD Co.,Ltd. CRO Division

s-hasegawa@qol-rd.co.jp03-6386-9500

Outcome results