Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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%
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
Design model
Single group
Treatments tested in this trial
Terazosine
DrugTitrating up to 5 mg PO at bedtime. Trial participants will take terazosin for 12 weeks.
Placebo
DrugPlacebo matching terazosin tablets
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: TerazosinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in ATP levels
Mean percent change from baseline to 12 weeks in whole-blood ATP and brain glycolytic rate using FDG-PET imaging
Time frame
Baseline and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov