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CompletedNCT04867551Updated May 11, 2022

A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease

A Phase 2 interventional study of KDT-3594 in Parkinson Disease, sponsored by Kissei Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by Kissei Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
20 Years to 79 Years
Sex
All
01

Study summary

Objective of this study is to investigate the safety, pharmacokinetics and efficacy of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Kissei Pharmaceutical Co., Ltd. is the lead sponsor of 63 studies on the registry; 3 are open to participants now.

Browse Kissei Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Japanese patients
  • Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
  • Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale

Exclusion criteria

Exclusion Criteria:

  • Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease.
  • Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
  • Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score \< 24 points
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    KDT-3594

    Drug: KDT-3594

Interventions

  • DrugKDT-3594

    oral administration, dose titration

06

What researchers measure

Primary outcomes

  1. Occurrence of adverse events

    The numbers of events and subjects, the incidence regarding adverse events.

    Time frame: 8 weeks

  2. Plasma concentrations of KDT-3594 and its metabolites

    Plasma concentrations of KDT-3594 and its metabolites during treatment period.

    Time frame: 8 weeks

Secondary outcomes

  1. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Change from baseline (Week 0) in MDS-UPDRS total score

    Time frame: 8 weeks

07

Study locations

1 site
  • Research Site
    Multiple Locations, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2021 to primary completion in Sep 2021, 3 months.

Of 97 industry-sponsored phase 2 interventional studies under Parkinson Disease, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 33. This study's 3 months is below that.

Counting every sponsor, half of 200 studies reached it within 28 months; a quarter within 16 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2021
First posted
Apr 30, 2021
StartActual
May 15, 2021
Primary completionActual
Sep 6, 2021
CompletionActual
Sep 6, 2021
Last update
May 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04867551
Lead sponsor
Kissei Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 30, 2021
Start date
May 15, 2021
Primary completion
Sep 6, 2021
Completion
Sep 6, 2021
Last update
May 11, 2022

Study contacts

Yoshitaka Shimizu
study director · Kissei Pharmaceutical Co., Ltd.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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