NCT06722729 - A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Parkinson Disease

Interventions

KDT-3594DRUG

Oral administration

PlaceboDRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Multiple Locations, Japan

Outcomes

Primary Outcomes

Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score at Week 17 of the treatment period

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)).

Time frame: Up to 17 weeks

Secondary Outcomes

Change from baseline in the MDS-UPDRS Part II+III (ON-time) total score

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)).

Time frame: Up to 17 weeks

Change from baseline in the MDS-UPDRS Part I, II, III, and IV (ON-time) total score

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)).