Terazosin and ATP in ALS: see if this drug helps energy in ALS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled pilot trial to test the safety and tolerability of terazosin at 5 mg daily in adults with ALS. The study will measure safety outcomes and ATP levels, using blood tests, spirometry, FDG-PET scans, questionnaires, and physical exams. Participants will be titrated to 5 mg per day and followed to see if terazosin can improve energy production in ALS, with results guiding future larger studies. This trial is not powered to determine efficacy but aims to explore the potential energy-related benefits and inform disease-modifying research in ALS.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA

* Ages 18 - 80 years old
* Diagnosed with ALS based on Gold Coast Criteria
* ALS symptom onset within 36 months at enrollment
* Slow vital capacity (SVC) greater than or equal to 60%
* Riluzole use-Never taken or taking a stable dose for at least 4 weeks prior to screening visit or will refrain from starting for the duration of the study
* Edaravone use-Never taken or completed at least one cycle (typically 14 days) prior to screening visit or will refrain from starting for the duration of the study
* Must have the ability to swallow pills at the time of the screening visit, and in the principle investigator's opinion, have the ability to swallow pills for the duration of the study
* Willing to use highly effective contraception for the duration of the trial treatment and for a duration of 80 days after the last dose.

EXCLUSION CRITERIA

* Orthostatic hypotension at screening is defined as decrease in BP \> 20 mmHg systolic or \> 10 mmHg diastolic and HR increase \<20 bpm on transition from supine to sitting or from sitting to standing
* Known allergy or previous adverse reaction to terazosin or related compound
* Current use of terazosin or concurrent use of doxazosin, alfuzosin, prazosin, or tamsulosin at the time of screening visit or within the 3 months prior to baseline visit
* Pregnancy or breastfeeding women
* Taking therapeutic anticoagulant medication (i.e. warfarin, DOAC's, full dose Lovenox or heparin)
* Liver function blood tests (ALT or AST) more than twice the upper limit of normal
* Hemoglobin \< 11.0 g/dL
* Traumatic brain injury or post-traumatic stress disorder
* Presence of a confounding acute or unstable medical, psychiatric, or orthopedic condition
* Noncompliant or sporadic use of medications that modulate the central nervous system
* Uncontrolled major depression or bipolar affective disorder, or other mental health disorders that are, in the opinion of the PI, sufficiently severe to increase risk of experiencing an Adverse Drug Reaction (ADR)
* Current suicidal ideation as measured by question 2 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Participants with insufficient decisional capacity to provide written informed consent determined by the primary investigator.
* Noncompliant or sporadic use of antihypertensive medications
* Unable to lie supine and still for 60 minutes for the duration of the study
* Currently taking part in another clinical trial with an investigational medicinal product or having taken part in one in the three months prior to screening visit
* Current diagnosis of diabetes (type 1 or type 2) or healthcare professional-recommended treatment (medication, exercise or diet) of diabetes mellitus
* Screening visit glucose \>140 mg/dl

Where it's running

• University of Iowa Health Care
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Andrea Swenson, MD — University of Iowa
• Study coordinator: Emily Anderson, RN, MSN
• Email: emily-anderson@uiowa.edu
• Phone: 319-356-8744

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Implanted Brain-Computer Interface to Help People with Severe Arm Impairment

  We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.

  Recruiting Neuralink Corp · Miami, Florida · NCT07929792

• Brain-computer interface chat tool for people with ALS

  This test compares a wearable brain-computer interface communication device to eye-tracking devices that people with ALS currently use to help them communicate.

  Recruiting Cognixion · Santa Barbara, California · NCT07871071

• BIIB147 safety and how it behaves in adults with ALS

  This study tests BIIB147 in adults with ALS to see if it is safe and how the body handles it, including early and long-term effects.

  Recruiting at 2 sites Phase 1/2 Biogen · St Louis, Missouri and 1 other locations · NCT07855211

• Aims to restore UNC13A function in people with ALS

  This trial tests TRCN-1023 in adults with ALS to see if it’s safe, tolerated, and shows early signs of benefit.

  Recruiting at 6 sites Phase 1/2 Trace Neuroscience, Inc. · Lübeck, Schleswig-Holstein and 5 other locations · NCT07674667

• LTX-002 in adults with ALS

  A study will test whether the experimental drug LTX-002 is safe and tolerable in adults with ALS and see how the body handles the drug and how it affects ALS indicators.

  Recruiting at 4 sites Phase 1/2 Leal Therapeutics, Inc · Lübeck and 4 other locations · NCT07660614

• Repeated ultrasound-assisted blood-brain barrier opening in ALS

  This trial tests whether repeatedly opening the blood-brain barrier with ultrasound is safe and may help people with ALS.

  Recruiting Phase 1/2 Assistance Publique - Hôpitaux de Paris · Paris · NCT07571486

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.