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Efficacy of KL1333 in Adult Patients With Primary Mitochondrial Disease

(FALCON)

Sponsored by Abliva AB

Quick Self-Assessment

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Oct 9, 2025

Phase

Clinical Trial

Sponsor

Abliva AB

Enrollment Target

180

Start Date

Dec 2022

๐Ÿ“Š
1 of 180 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily living as well as on functional lower extremity strength and endurance. Additionally, the study evaluates the safety and tolerability of KL1333.

Who Can Participate

Inclusion Criteria

Age 18 years or older.
A confirmed PMD diagnosis caused by a known pathogenic gene mutation or deletion of the mitochondrial genome (category 6 of the International Classification of Inborn Metabolic Disorders \[ICIMD\])12 according to American College of Medical Genetics (ACMG)/Association of Molecular Pathology (AMP) criteria1, with multisystemic disease expressions, including: 1. m.3243A\>G associated MELAS-MIDD spectrum disorders, 2. single large scale mtDNA deletion associated KSS-CPEO spectrum disorders, 3. other multisystemic mtDNA-related disease (including MERRF).
Presence of chronic mitochondrial fatigue:
History of mitochondrial fatigue for at least 3 months prior to the Screening Visit AND
Presence of at least moderate level of fatigue, assessed by PROMISยฎ Fatigue PMD Short form raw score โ‰ฅ 27 at Screening and Baseline
Presence of mitochondrial myopathy defined as:
Myopathy (proximal muscle weakness), NMDAS Section III Clini

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

180 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Abliva AB

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Akron

Ohio

Location available
View Akron location page
RECRUITING

Houston

Texas

Location available
View Houston location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

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Looking for Primary Mitochondrial Disease Treatment in Akron?

Join others in Ohio exploring innovative treatment options through clinical research

Primary Mitochondrial Disease Treatment Options in Akron, Ohio

If you're searching for Primary Mitochondrial Disease treatment in Akron, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Akron, Houston, Brussels and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Primary Mitochondrial Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Ohio
Now Enrolling
Up to 180 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Primary Mitochondrial Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Primary Mitochondrial Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Primary Mitochondrial Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05650229. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.