A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease
- Registration Number
- NCT06722729
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Brief Summary
This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks in patients with advanced PD with levodopa.
- Detailed Description
This trial is a late phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety, and pharmacokinetics of KDT-3594 administered once daily in patients with advanced PD with levodopa.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KDT-3594 KDT-3594 KDT-3594 capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks. Placebo Placebo Placebo capsules will be orally administered at escalating doses ranging from 0.25 to 2 mg per day for 17 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period 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.
* Part I: 0-52
* Part II: 0-52
* Part III: 0-132
* Part IV: 0-24
* Total Score: 0-260
* Part II+III: 0-184 (MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (range 0-184)).
- Secondary Outcome Measures
Name Time Method Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score 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.
* Part I: 0-52
* Part II: 0-52
* Part III: 0-132
* Part IV: 0-24
* Total Score: 0-260
* Part II+III: 0-184 (MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (range 0-184)).Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score 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.
* Part I: 0-52
* Part II: 0-52
* Part III: 0-132
* Part IV: 0-24
* Total Score: 0-260
* Part II+III: 0-184 (MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (range 0-184)).Response rate in the MDS-UPDRS Part III (ON-time) total score 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.
* Part I: 0-52
* Part II: 0-52
* Part III: 0-132
* Part IV: 0-24
* Total Score: 0-260
* Part II+III: 0-184 (MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (range 0-184)).Change from baseline in the proportion of OFF-time in awake time Up to 17 weeks Change from baseline in OFF-time Up to 17 weeks Incidence of adverse events and treatment-related adverse events Up to 17 weeks
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Trial Locations
- Locations (1)
Research Site
🇯🇵Multiple Locations, Japan