A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease
A Late Phase II Clinical Trial of KDT-3594 in Patients With Advanced Parkinson's Disease With Levodopa
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Tokyo and Other Japanese Cities, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with PD according to the Parkinson's disease society brain bank clinical diagnostic criteria of the UK Parkinson's Disease Society
- Patients who are being treated with levodopa or levodopa combination drugs and have any of the following troublesome symptoms or conditions:
- Patients with wearing-off phenomenon
- Patients with ON-/OFF-phenomenon
- Patients with no-on/delayed on phenomenon
- Patients with inadequate response to levodopa
Exclusion Criteria:
- Patients suspected of having parkinsonism other than PD based on medical history, physical findings, laboratory test values, dopamine transporter-single photon emission computed tomography (DAT-SPECT), etc.
- Patients who have undergone neurosurgical therapy for PD (e.g., stereotactic thalamotomy and pallidotomy and deep brain stimulation) or who are scheduled to undergo surgical therapy during the trial period
- Patients complicated with overt dementia or a Mini-Mental State Examination (MMSE) score of < 24 at the start of the screening period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: KDT-3594
KDT-3594 capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks.
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Oral administration
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Placebo Comparator: Placebo
Placebo capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks.
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Oral administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period
Time Frame: Up to 17 weeks
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MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question, a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. In all parts, a higher score indicated more severe symptoms of PD, and the score range of each part are as follows.
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Up to 17 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score
Time Frame: Up to 17 weeks
|
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question, a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. In all parts, a higher score indicated more severe symptoms of PD, and the score range of each part are as follows.
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Up to 17 weeks
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Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score
Time Frame: Up to 17 weeks
|
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question, a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. In all parts, a higher score indicated more severe symptoms of PD, and the score range of each part are as follows.
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Up to 17 weeks
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Response rate in the MDS-UPDRS Part III (ON-time) total score
Time Frame: Up to 17 weeks
|
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question, a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. In all parts, a higher score indicated more severe symptoms of PD, and the score range of each part are as follows.
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Up to 17 weeks
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Change from baseline in the proportion of OFF-time in awake time
Time Frame: Up to 17 weeks
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Up to 17 weeks
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Change from baseline in OFF-time
Time Frame: Up to 17 weeks
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Up to 17 weeks
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Incidence of adverse events and treatment-related adverse events
Time Frame: Up to 17 weeks
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Up to 17 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KDT1203
- Under registration (Registry Identifier: jRCT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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