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IkT-148009 for Parkinson's Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have advanced or intermediate age-related vision loss.My Parkinson's disease is in the early or mid-stage.I can join the trial without needing extra Parkinson's disease treatment.I can sign and will follow the study's rules.I experience significant dizziness when standing up.I haven't taken Parkinson's disease medications or supplements for over 28 days.I am currently taking medication that strongly affects liver enzymes.I have abnormal blood vessel growth in my eye.I have Parkinson's disease with slow movements and uneven symptoms on both sides.I am not on any medication for Parkinson's disease.I have Parkinson's disease with slow movements and uneven symptoms on both sides.I am not on any Parkinson's disease medication.I might have a rare form of Parkinson's disease.I have serious kidney problems.I have not had thoughts of harming myself in the past year.I am not on any medication for Parkinson's disease.I am currently taking medication for psychosis, nausea, or ADHD.I stopped taking certain depression/Parkinson's medications over 90 days ago.My Parkinson's disease is in the early or mid-stage.I agree to use effective birth control.I've needed antipsychotics for severe hallucinations in the last year.I agree to use birth control or remain abstinent during and 30 days after the study.I do not have skin conditions affecting sample collection.I have had or am expected to have surgery for Parkinson's disease during the study.You score 26 or higher on the Montreal Cognitive Assessment test.You are able to participate in the trial without needing extra medication for Parkinson's disease.
- Group 1: Placebo
- Group 2: 50mg IkT-148009
- Group 3: 100mg IkT-148009
- Group 4: 200mg IkT-148009
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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"
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."
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."
Who else is applying?
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