Amyotrophic Lateral SclerosisEarly Phase 1TZ-ALSNCT07224269
Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis
A Early Phase 1 study testing Terazosine in people with Amyotrophic Lateral Sclerosis and Adenosine Triphosphate Activities, run by University of Iowa at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Adenosine Triphosphate Activities
- What is being tested?
- Terazosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2026to 31 Oct 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Emily Anderson, RN, MSN, 319-356-8744, emily-anderson@uiowa.edu
Heena Olalde, RN, MSN, 319-356-8326, heena-olalde@uiowa.edu
About this study
Official title: A Pilot Study of the Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis
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.
- Being tested
- Terazosine, Placebo
- Keywords
- amyotrophic lateral sclerosis, terazosin, clinical trial
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerazosineDrug
Titrating up to 5 mg PO at bedtime. Trial participants will take terazosin for 12 weeks.
PlaceboDrug
Placebo matching terazosin tablets
| Study group | Role | What they receive |
|---|---|---|
| Terazosin | Experimental | Not described Receives: Drug: Terazosine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ATP levels
Mean percent change from baseline to 12 weeks in whole-blood ATP and brain glycolytic rate using FDG-PET imaging
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start12 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Swenson, University of Iowa
- Investigators
- Andrea Swenson, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224269
- Sponsor's protocol ID
- 202408197
- Acronym
- TZ-ALS
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No