NCT07224269 · University of Iowa
Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis
(TZ-ALS)
What this study is about
This will be a single center, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment pilot study to assess the safety and how well patients handle the treatment of terazosin (TZ) at a dose of 5 milligrams (mg) per os (PO) daily for patients with amyotrophic lateral sclerosis (ALS).
View original scientific description
This will be a single center, randomized, double-blind, placebo-controlled pilot study to assess the safety and tolerability of terazosin (TZ) at a dose of 5 milligrams (mg) per os (PO) daily for patients with amyotrophic lateral sclerosis (ALS). The primary outcome of this study is to determine whether TZ increases adenosine triphosphate (ATP) levels in ALS. The investigators will measure adverse outcomes, safety, and tolerability of taking TZ. Procedures include blood draws, spirometry, fluorodeoxyglucose-positron emission tomography (FDG-PET) scans, questionnaires, and physical examinations. TZ will be titrated up to 5 mg PO daily. This is a pilot study and is not powered to assess efficacy of this medication. The investigators' hope is that this study will guide future studies of this (and similar) medications for the disease modification of ALS. This study also aims to learn more about how patients produce and use energy and if TZ can help to reverse energy deficits that appear in ALS.
Interventions
DRUG
Terazosine
Titrating up to 5 mg PO at bedtime. Trial participants will take terazosin for 12 weeks.
DRUG
Placebo
Placebo matching terazosin tablets
Primary outcome measures
Change in ATP levels
Time frame: Baseline and 12 weeks
Mean percent change from baseline to 12 weeks in whole-blood ATP and brain glycolytic rate using FDG-PET imaging
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 65%
- 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
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations