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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT07224269
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Terazosine — DRUG
    Titrating up to 5 mg PO at bedtime. Trial participants will take terazosin for 12 weeks.
  • Placebo — DRUG
    Placebo matching terazosin tablets

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Terazosin
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in ATP levels [ Time Frame: Baseline and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Emily Anderson, RN, MSN
[email protected]
319-356-8744
Heena Olalde, RN, MSN
[email protected]
319-356-8326
Andrea Swenson, MD (PRINCIPAL_INVESTIGATOR)

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