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Terazosin for ALS and ATP Levels

This study is looking at how a drug called terazosin affects people with Amyotrophic Lateral Sclerosis (ALS). Researchers want to see if terazosin can increase adenosine triphosphate (ATP) levels in the body, which are important for energy. You might be able to join if you are 18 to 80 years old, have an ALS diagnosis within the last 36 months, and your lung function (slow vital capacity or SVC) is above 65%. You also need to be on a stable dose of riluzole or edaravone, or not taking them. This is a small pilot study with 20 participants to check the safety and tolerability of terazosin, not to see if it cures ALS. The study will compare terazosin to a placebo (an inactive pill).

Study design
This is a single-center, randomized, double-blind, placebo-controlled pilot study with 20 participants.
What's involved
You would take terazosin or a placebo for 12 weeks, titrating up to 5 mg daily. Procedures include blood draws, lung function tests (spirometry), brain scans (FDG-PET scans), questionnaires, and physical exams.
Compensation
Not stated in the trial record.
Follow-up
ATP levels will be measured at the beginning and after 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224269

Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis

Recruiting
EARLY_PHASE1Ages 18–80InterventionalBasic science
University of Iowa
~20 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:TerazosinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ATP levels
Measured over Baseline and 12 weeks

Conditions

Amyotrophic Lateral Sclerosis
Adenosine Triphosphate Activities

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Amyotrophic Lateral Sclerosis

NCT07224269

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Iowa Health Care

    Iowa City, Iowastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrea Swenson, MD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Emily Anderson, RN, MSN
[email protected]
319-356-8744
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in ATP levelsBaseline and 12 weeks

    Mean percent change from baseline to 12 weeks in whole-blood ATP and brain glycolytic rate using FDG-PET imaging