Your session is about to expire
← Back to Search
KL1333 for Mitochondrial Disease (FALCON Trial)
FALCON Trial Summary
This trial aims to test a new drug for primary mitochondrial disease, to see if it helps with fatigue, daily living, and strength/endurance. It also checks for safety.
FALCON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFALCON Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FALCON Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have a mitochondrial disease mainly affecting my nervous system.I have a genetic mutation linked to mitochondrial disease.I have muscle weakness or struggle with physical activity due to mitochondrial myopathy.I have been feeling extremely tired for more than 3 months.I am stable except for my mitochondrial disease symptoms.I haven't taken any experimental drugs within the last 30 days.I have a confirmed PMD diagnosis with symptoms affecting multiple systems in my body.I have not fully recovered from recent severe illness or stroke-like episodes.My lab tests show values that could be risky for my health.I experience fatigue or muscle weakness not caused by mitochondrial disease.I am not pregnant and follow the required birth control measures.I do not have severe or unstable lung, immune system, liver, kidney diseases, or other serious illnesses.I have sleep apnea that hasn't been treated or is under-treated.I am 18 years old or older.I have heart disease or an abnormal heart test result.I am not pregnant.I have been on stable doses of vitamins or supplements for my mitochondrial disease for 3 months.I often feel very tired.I am willing to stop taking idebenone for the study.I have a history of stomach issues or acid reflux.I do not have severe balance or nerve problems that would affect my ability to perform a sit-to-stand test.You are allergic to the active drug or any of its ingredients.I can attend all study appointments as scheduled.I have not taken idebenone in the last 14 days.
- Group 1: KL1333
- Group 2: Matching Placebo
- 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
Has the U.S. Food and Drug Administration accepted KL1333 for therapeutic usage?
"The safety rating for KL1333 is 2, as this phase two trial has some evidence suggesting it's harmless but not yet any data corroborating its effectiveness."
How many people have volunteered to take part in this research project?
"Affirmative. Clinicaltrials.gov's data shows that this trial is currently enrolling patients, with the initial posting dating to December 13th 2022 and last updated on April 19th 2023. The study requires 180 participants from 7 different research sites."
How widely is this scientific experiment being implemented in Canada?
"Currently, this trial is enrolling patients in 7 different sites around the world, such as Madrid, Houston and Barcelona. To reduce unnecessary travel costs for participants it would be wise to choose the closest available location if you decide to join."
Are there any vacancies available to participate in this trial?
"That is correct. Clinicaltrials.gov reveals that this study, initially posted on December 13th 2022, is currently enrolling participants. The researchers plan to recruit 180 people from 7 clinical trial sites."
What end results are the researchers hoping to demonstrate through this clinical trial?
"This clinical trial, taking place over the course of 48 weeks, plans to evaluate patient-reported fatigue symptoms and daily living through PROMIS® Fatigue PMD Short Form. Secondary objectives include a Global Impression of Change Scale ranging from 2 (much better) to -2 (much worse), as well as changes in t-score on Neuro-QoL Lower Extremity Function for mobility and an Individual Activity Interference scale with ratings from "No interference" to "Completely interferes"."
Share this study with friends
Copy Link
Messenger