50mg IkT-148009 for Parkinson Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Neurologist, Tampa, FL
Parkinson Disease
IkT-148009 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

Other trials for Parkinson Disease

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

2 of 3
This is further along than 68% of similar trials

Other trials for Parkinson Disease

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: Drug
200mg IkT-148009
Drug
Experimental Group · 1 Intervention: IkT-148009 · Intervention Types: Drug
100mg IkT-148009
Drug
Experimental Group · 1 Intervention: IkT-148009 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through week 16
Closest Location: Neurologist · Tampa, FL
Photo of Tampa  1Photo of Tampa  2Photo of Tampa  3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.