50mg IkT-148009 for Parkinson Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Neurologist, Tampa, FL
Parkinson Disease
IkT-148009 - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
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Study Summary
This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (55 to 75 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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 12 Secondary · Reporting Duration: Day 1 through week 16
Week 12
Clinician Global Impression of Severity (CGI-S)
Complete Spontaneous Bowel Movement (CSBM)
Epworth Sleepiness Scale (ESS)
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II + III
Non-Motor Symptom Scale (NMSS)
Parkinson's Disease Questionnaire (PDQ-39)
Patient Assessment of Constipation Quality of Life (PAC-QOL)
Patient Assessment of Gastrointestinal Disorders Severity Quality of Life (PAGI- QOL)
Patient Assessment of Upper Gastrointestinal Disorders Severity Index (PAGI-SYM)
Patient Global Impression-Severity (PGI-S)
Phosphorylated alpha-synuclein in cerebrospinal fluid (CSF)
Phosphorylated alpha-synuclein in skin
Schwab and England Activities of Daily Living (SE-ADL) Scale
WGTT Exploratory
Week 12
Proportion of those randomized in each dosing cohort who discontinued the assigned regimen
Week 16
Incidence and temporal profile of treatment-emergent adverse events (TEAEs) evaluated by type/nature, severity/intensity, seriousness, and relationship to study intervention
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
50mg IkT-148009
1 of 4
200mg IkT-148009
1 of 4
100mg IkT-148009
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group
120 Total Participants · 4 Treatment Groups
Primary Treatment: 50mg IkT-148009 · Has Placebo Group · Phase 2
50mg IkT-148009
Drug
Experimental Group · 1 Intervention: IkT-148009 · Intervention Types: Drug200mg IkT-148009
Drug
Experimental Group · 1 Intervention: IkT-148009 · Intervention Types: Drug100mg IkT-148009
Drug
Experimental Group · 1 Intervention: IkT-148009 · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through week 16
Closest Location: Neurologist · Tampa, FL
N/AFirst Recorded Clinical Trial
1 TrialsResearching Parkinson Disease
0 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have PD consistent with UK Brain Bank criteria and MDS Research Criteria.
You have a modified Hoehn/Yahr stage of less than 3.0.
You have a Montreal Cognitive Assessment score of at least 26.
You are able to participate in the trial without need for additional anti-Parkinsonian therapy.
You are able to give ICF as described in Appendix 1.
You are approved as an appropriate and suitable candidate for admission to the University of British Columbia.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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