Parkinson DiseasePhase 2NCT03845387
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
A Phase 2 study testing KDT-3594 and Pramipexole in people with Parkinson Disease, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- KDT-3594 and Pramipexole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteJapan
- Study dates
- 26 Feb 2019to 21 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.
- Conditions
- Parkinson Disease
- Being tested
- KDT-3594, Pramipexole
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDT-3594Drug
oral administration, dose titration
PramipexoleDrug
ER formulation, oral administration, dose titration
| Study group | Role | What they receive |
|---|---|---|
| KDT-3594 | Experimental | Not described Receives: Drug: KDT-3594 |
| Pramipexole | Other | Reference drug Receives: Drug: Pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Change from baseline (Week 0) in MDS-UPDRS total score
Measured: 12 weeks
Secondary outcomes (2)
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score
Change from baseline (Week 0) in PDQ-39 summary index score
Measured: 12 weeks
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
Change from baseline (Week 0) in PDSS-2 total score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start26 Feb 2019
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naomi Koshihara, Study director, Kissei Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845387
- Sponsor's protocol ID
- KDT1201
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03845387
- Acronym / sponsor ID
- KDT1201
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KDT-3594 | Experimental | Drug: KDT-3594 |
| Pramipexole | Other | Drug: PramipexoleReference drug |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDT-3594oral administration, dose titration | Drug | KDT-3594 |
| PramipexoleER formulation, oral administration, dose titration | Drug | Pramipexole |
Primary outcome
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Time frame: 12 weeks
Change from baseline (Week 0) in MDS-UPDRS total score
2 secondary outcomes
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score
Time frame: 12 weeks
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Koshihara study director
Kissei Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KDT-3594 and Pramipexole in people with Parkinson Disease, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.