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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Iowa

About this trial

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.

Eligibility criteria

Qualifiers

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) > 65%

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Terazosine
  • Placebo

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators