Is NCT07287397 recruiting in Miami, FL?

Yes, NCT07287397 is currently recruiting participants at its Miami, FL location. This amyotrophic lateral sclerosis clinical trial is actively enrolling qualified participants.

How do I join the amyotrophic lateral sclerosis clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Amyotrophic Lateral Sclerosis Clinical Trial in Miami, FL

About This Amyotrophic Lateral Sclerosis Study in Miami

PIONEER-ALS is a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS). Two escalating dose (low dose and high dose) cohorts are planned. The duration of the study will be a maximum of 5 years and 5 weeks (265 weeks) for each participant. The screening period may last up to 5 weeks to complete screening procedures.

Sponsor: Vector Y Therapeutics

Who Can Participate

Inclusion Criteria

Capable of, and willing to, provide written informed consent and comply with study procedures, including visits to the study site and visit requirements

Male or female ≥ 18 years of age

Has a diagnosis of ALS according to the El Escorial criteria (Brooks, et al., 2000) (probable, laboratory results supported; clinically probable, clinically definite)

Confirmed absence of ALS caused by FUS and SOD1 gene mutations confirmed by laboratory tests.

A maximum of 18 months since first appearance of weakness (e.g., limb weakness, dysarthria, dysphagia, shortness of breath)

Erect (seated) SVC % predicted ≥ 80% at Screening

Treatment Research Initiative to Cure ALS (TRICALS) risk score between -2 and -6 at Screening

Has a reliable caregiver/partner/legal representative willing and able to support the participant in participation in the study and to give informed consent on behalf of the participant in the case that disease progression prevents the participant of giving consent (local legal rules will apply).

Treatment with riluzole and/or edaravone is allowed if treatment was started and has remained at a stable dose for at least 2 weeks (riluzole) or one treatment cycle (edaravone) before the Screening visit

Women of childbearing potential (WOCBP) and male participants with female partners who are WOCBP must agree to use highly effective contraception during and after the study. WOCBP cannot be pregnant or breastfeeding

Women of nonchildbearing potential must be post-menopausal or surgically sterile (e.g. hysterectomy, bilateral tubal ligation, ovaries removed) Key

Exclusion Criteria

Diagnosis of a significant CNS or peripheral nervous system disease other than ALS that may be a cause for the participant's ALS symptoms or may confound study objectives

Spinal, cervical, or brain MRI/MRA indicating clinically significant abnormality

Presence of tracheostomy and feeding tube at Screening

Contraindications to corticosteroid use (e.g. due to osteoporosis, uncontrolled blood pressure, diabetes or cholesterol). 5\. Significant concomitant disease or condition within 6 months of Screening that could pose an unacceptable safety risk to the participant or interfere with the participant's ability to comply with study procedures, e.g. heart disease, uncontrolled diabetes, liver disease, autoimmune diseases needing strong immune-suppressing drugs, cancer, etc or a current psychiatric diagnosis. 6\. Clinically significant abnormalities in laboratory test results at Screening for example poor liver or kidney function, abnormal clotting or infections such as Hepatitis or HIV 7\. Use of blood thinners (e.g., warfarin, heparin, and novel oral anticoagulants) and being unable to safely stop them before certain study procedures. 8\. Contraindications to imaging methods MRI, MRA, CT due to claustrophobia and/or intolerance to contrast agents. 9\. Contraindications to general anaesthesia (GA) or deep sedation 10 Positive test for illegal drugs (except prescribed medications or permitted medicinal/recreational marijuana if used responsibly) 11\. Generally frail or if the Investigator deems participation in the study would not be in the best interest of the participant or is likely to prohibit further participation during the study Other protocol-defined inclusion/exclusion criteria may apply \-

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT07287397) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Amyotrophic Lateral Sclerosis Treatment Options in Miami, FL

If you're searching for amyotrophic lateral sclerosis treatment options in Miami, FL, this clinical trial (NCT07287397) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced amyotrophic lateral sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all amyotrophic lateral sclerosis clinical trials near you to find additional studies recruiting in your area.

Amyotrophic Lateral Sclerosis Clinical Trial in Miami, FL

Expert Care in Miami

IRB Approved

No-Cost Care

Apply for This Miami Location

Why Participate?

Simple Process