A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease
- Registration Number
- NCT05424276
- Lead Sponsor
- ABLi Therapeutics, Inc.
- Brief Summary
This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com
- Detailed Description
This is a 12-Week, randomized, double-blind, multi-center, placebo-controlled dose-ranging clinical trial of three IkT 148009 doses in patients with untreated PD designed to assess safety, tolerability, and pharmacokinetics of IkT-148009, an oral, once daily c-Abl tyrosine kinase inhibitor. Secondary and exploratory assessments will evaluate the effect of IkT-148009 on motor and non-motor features of the disease. 120 participants are anticipated to be enrolled at up to 34 sites across the US.
Participants will undergo screening to evaluate their eligibility to participate in the study to include evaluation of Parkinson's diagnosis, vital signs, blood chemistry, hematology and urinalysis and complete listing of concomitant medications. An Enrollment Authorization Committee (EAC) will be responsible for reviewing screening data and confirming the eligibility and suitability of participants. Those selected will be enrolled and randomized to one of three active IkT-148009 arms (50/100/200 mg) or a placebo arm (1:1:1:1). All clinical staff, study investigators, and participants will be blinded to study assignments throughout the trial.
A Data Safety Monitoring Committee (DSMB) will evaluate all available safety, tolerability, and PK and Parkinson's disease-related data for each cohort on a monthly to quarterly basis. Adverse event reporting will be evaluated in real-time.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50mg IkT-148009 IkT-148009 This arm will consist of thirty (30) patients on 50mg of active treatment. 100mg IkT-148009 IkT-148009 This arm will consist of thirty (30) patients on 100mg of active treatment. 200mg IkT-148009 IkT-148009 This arm will consist of thirty (30) patients on 200mg of active treatment. Placebo Placebo This arm will consist of thirty (30) patients on placebo.
- Primary Outcome Measures
Name Time Method Incidence and temporal profile of treatment-emergent adverse events (TEAEs) evaluated by type/nature, severity/intensity, seriousness, and relationship to study intervention Day 1 through week 16 Proportion of those randomized in each dosing cohort who discontinued the assigned regimen Day 1 through week 12
- Secondary Outcome Measures
Name Time Method Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II + III Change from Baseline to Week 12 Higher scores mean worse outcome from 0 to 52
Patient Global Impression-Severity (PGI-S) Change from Baseline to Week 12 Scale varies from None to Very Severe
Clinician Global Impression of Severity (CGI-S) Change from Baseline to Week 12 Higher scores mean worse outcome between 1 and 7.
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Change from Baseline to Week 12 Higher scores mean worse outcome from 0 to 52.
Non-Motor Symptom Scale (NMSS) Change from Baseline to Week 12 Higher scores mean worse outcome from 0 to 360.
Complete Spontaneous Bowel Movement (CSBM) Change from Baseline to Week 12 A value \< 3 implies constipation
Epworth Sleepiness Scale (ESS) Change from Baseline to Week 12 Higher score means worse outcome from 0 to 24.
Schwab and England Activities of Daily Living (SE-ADL) Scale Change from Baseline to Week 12 Higher score means worse outcome from 0% to 100%
Parkinson's Disease Questionnaire (PDQ-39) Change from Baseline to Week 12 Higher scores mean worse outcome from 0 to 100.
Patient Assessment of Upper Gastrointestinal Disorders Severity Index (PAGI-SYM) Change from Baseline to Week 12 Higher score means worse outcome from 0 to 100.
Patient Assessment of Constipation Quality of Life (PAC-QOL) Change from Baseline to Week 12 Higher score means worse outcome from 0 to 150.
Patient Assessment of Gastrointestinal Disorders Severity Quality of Life (PAGI- QOL) Change from Baseline to Week 12 Higher score means worse outcome from 0 to 150.
Trial Locations
- Locations (2)
Neurology
🇺🇸Milwaukee, Wisconsin, United States
Neurologist
🇺🇸Boca Raton, Florida, United States