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IkT-148009 for Parkinson's Disease

Phase 2
Recruiting
Led By Sydney Kruger
Research Sponsored by Inhibikase Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants diagnosed with PD consistent with UK Brain Bank criteria and MDS Research Criteria; must include bradykinesia with sequence effect and motor asymmetry
Receiving no anti-parkinsonian therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through week 16
Awards & highlights

Study Summary

This trial looks at the safety and tolerability of a new drug for Parkinson's Disease, as well as how it affects different symptoms of the disease. The study will last 12 weeks and involve either taking the drug or a placebo.

Who is the study for?
This trial is for people aged 30-80 with untreated Parkinson's Disease (PD) who meet specific medical criteria and can self-administer a drug daily with food. They must not need other PD treatments during the study, agree to birth control methods if of childbearing potential, and have no significant health issues that could affect participation.Check my eligibility
What is being tested?
The trial tests IkT-148009's safety and how it affects the body compared to a placebo in managing Parkinson's symptoms. Participants will randomly receive either one of three doses of IkT-148009 or a placebo once daily for 12 weeks.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to IkT-148009 which may include typical drug-related responses such as gastrointestinal discomfort, allergic reactions, or changes in mood or motor function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Parkinson's disease with slow movements and uneven symptoms on both sides.
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I am not on any medication for Parkinson's disease.
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My Parkinson's disease is in the early or mid-stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and temporal profile of treatment-emergent adverse events (TEAEs) evaluated by type/nature, severity/intensity, seriousness, and relationship to study intervention
Proportion of those randomized in each dosing cohort who discontinued the assigned regimen
Secondary outcome measures
Clinician Global Impression of Severity (CGI-S)
Complete Spontaneous Bowel Movement (CSBM)
Epworth Sleepiness Scale (ESS)
+9 more
Other outcome measures
Phosphorylated alpha-synuclein in cerebrospinal fluid (CSF)
Phosphorylated alpha-synuclein in skin

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 50mg IkT-148009Experimental Treatment1 Intervention
This arm will consist of thirty (30) patients on 50mg of active treatment.
Group II: 200mg IkT-148009Experimental Treatment1 Intervention
This arm will consist of thirty (30) patients on 200mg of active treatment.
Group III: 100mg IkT-148009Experimental Treatment1 Intervention
This arm will consist of thirty (30) patients on 100mg of active treatment.
Group IV: PlaceboPlacebo Group1 Intervention
This arm will consist of thirty (30) patients on placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IkT-148009
2021
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Inhibikase Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
165 Total Patients Enrolled
Sydney KrugerPrincipal InvestigatorInhibikase Therapeutics, Inc.
Milton Werner, PhDPrincipal InvestigatorInhibikase Therapeutics, Inc.

Media Library

IkT-148009 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05424276 — Phase 2
Parkinson's Disease Research Study Groups: Placebo, 50mg IkT-148009, 100mg IkT-148009, 200mg IkT-148009
Parkinson's Disease Clinical Trial 2023: IkT-148009 Highlights & Side Effects. Trial Name: NCT05424276 — Phase 2
IkT-148009 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424276 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for this trial limited to those 18 and older?

"The scope of this clinical trial is restricted to individuals between the ages 30 and 75; there are 27 trials for minors, while 481 studies cater to elderly patients."

Answered by AI

To what extent is IkT-148009 known to be detrimental for humans?

"Our team at Power assigned IkT-148009 a score of 2, indicating that while the data suggests it is safe to use, there are no known cases where efficacy has yet been established."

Answered by AI

Is this research project currently open to participants?

"Affirmative. Clinicaltrials.gov confirms that this medical experiment is presently recruiting people to participate; the study was initially published on May 23rd 2022 and has recently seen an update June 17th 2022. This trial requires 120 individuals across a single location."

Answered by AI

What criteria need to be met in order for an individual to participate in this research?

"This trial is currently recruiting 120 individuals aged between 30 and 75 that have been diagnosed with Parkinson's disease. Furthermore, participants must meet specific criteria such as: compliant with UK Brain Bank and MDS Research Criteria; no anti-parkinsonian therapy being administered; Modified Hoehn/Yahr Stage below 3.0; Montreal Cognitive Assessment score above 26; capable of providing written consent for the study protocol prior to enrollment etc. Male participants are obligated to use effective birth control methods throughout the duration of this clinical trial while female participants of childbearing potential need to guarantee reliable contraception until at least one month after receiving their last dose of"

Answered by AI

What are the main goals that this medical experiment seeks to achieve?

"The primary objective assessed by Inhibikase Therapeutics, Inc., the study sponsors, is to record and assess Treatment Emergent Adverse Events (TEAEs) over a 12 week interval. To supplement this metric, secondary outcomes such as Epworth Sleepiness Scale (ESS), Movement Disorder Society-sponsored revision of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Parts II + III, and Patient Assessment of Gastrointestinal Disorders Severity Quality of Life (PAGI-QOL) will be observed with higher scores representing worse results on a scale from 0 to 150."

Answered by AI

What is the current participant count within this clinical investigation?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical study launched on May 23rd 2022 and has recently made changes as of June 17th 2022. It is currently looking for 120 participants at one particular centre."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
Neurologist
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~28 spots leftby Jun 2024