Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug

Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug - Clinical trial for PSP using anticholinergic drug

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036522

Enrollment

Registered

2019-04-16

Start date

2019-04-15

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

Progressive supranuclear palsy

Interventions

Trihexyphenidyl hydrochloride max.3mg for 3 months Placebo max. 3mg for 3 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)>=40 years old patient with progressive supranuclear palsy (PSP) when obtained informed consent 2) sporadic PSP 3) slowly progressive course 4)patient with freezing gait: the patients meet MDS-PSP criteria such as [probable PSP-RS(O1 or O2)+(P1 or P2), probable PSP-PGF (O1 or O2)+A1, possile PSP-RS (O2 +P3) or possible PSP-PGF A1] 5) severity of PSP 1-5 (except for 6) 6) >=15 points of MMSE score 7) existence of reliable care giver for the patient 8) researcher can obtain the written consent from the patient. Included a patient who meets the aobove mentioned all items.

Exclusion criteria

Exclusion criteria: 1) attending other clinical trials 2) alcohol dependence or drug abuser 3) psychiatric disorder 4) allergy for anti-cholinergic drugs 5) severe liver or renal dysfunction 6) effective for levodopa, and/or using following drugs: anti-psychiatric agents, anti-epileptic drugs, acethycholine esterase inhibitor, memantine, immunosuppressant, corticosteroids, anti-coagulant, lithium, or anti-cholinergic drug 7) not suitable for clinical trial judged by principal investigator or researchers.

Design outcomes

Primary

Measure	Time frame
Difference of summation of scores 13-15, and 29-30 items of UPDRS and 2.12-2.13 items of MDS-UPDRS between pretreatment and 3 months after the treatment	—

Secondary

Measure	Time frame
Score of PSPRS, MMSE, FAB, MoCA, volume of voice, voice duration, timed up & go test, score of FOGQ, modified Schwab & England ADL scale, frequency of urination, and side effect	—

Countries

Japan

Contacts

Public ContactYuichi Hayashi

Gifu University Graduate School of Medicine Department of Neurology

hayashiy@gifu-u.ac.jp0582306254

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026