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Contact Information:

Miss Emma Harper
+44 (0)1865 234829
trust@ndcn.ox.ac.uk


Prof Kevin Talbot
+44 (0)1865 223380
kevin.talbot@ndcn.ox.ac.uk


Dr Elizabeth Gray
+44 (0)7944 184795
elizabeth.gray@ndcn.ox.ac.uk


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Be Part of Research - Trial Details - A pilot trial to test whether terazosin treatment lowers the levels of biomarkers of neurodegeneration (nerve cell damage) in the blood, spinal fluid, and urine of amyotrophic lateral sclerosis patients over 6 months
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A pilot trial to test whether terazosin treatment lowers the levels of biomarkers of neurodegeneration (nerve cell damage) in the blood, spinal fluid, and urine of amyotrophic lateral sclerosis patients over 6 months

Not Recruiting

Open to: All Genders

Age: Adult

Oxford

Medical Conditions

Amyotrophic lateral sclerosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is a neurodegenerative disease in which motor neurons deteriorate leading to progressive weakness. Treatment options are very limited. Laboratory evidence suggests that an enzyme called phosphoglycerate kinase 1 (PGK1) might help to protect motor neurons by increasing their energy availability. The drug terazosin is known to activate PGK1, and researchers at the University of Oxford and University of Edinburgh have shown that terazosin helps motor neuron survival in laboratory models of the disease. Terazosin is a drug that is routinely prescribed to patients either for high blood pressure or for symptoms arising from an enlarged prostate gland in men, where it acts through a different mechanism from PGK1 activation.

As motor neurons deteriorate in ALS, they release substances that can be measured in body fluids and give an indication of how active the disease is. These are called biomarkers. In this pilot study, we will test whether terazosin treatment significantly lowers the levels of biomarkers in the blood, spinal fluid and urine at intervals over the course of 6 months. We will also monitor clinical measurements of disease progression, such as the ALS Functional Rating Score and the spirometry ‘breathing’ test, which are carried out as part of your routine clinical appointments. If this study shows that terazosin alters biomarker levels, suggesting that it potentially slows the disease process in patients with ALS, it would then make a strong case for a larger-scale clinical trial.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

03 Aug 2022 31 May 2024

Participants will take up to 10mg oral terazosin daily for up to 6 months. There will be 3 face-to-face study visits (at baseline, 3 months and 6 months), involving the following procedures: ALSFRS-R questionnaire, spirometry test, blood samples, lumbar puncture, urine sample, blood pressure measurement.


Adults over 18 years, diagnosed with ALS and first onset of symptoms between 9 - 24 months ago.

You can take part if:



You may not be able to take part if:


1. Using non-invasive ventilation (NIV)2. Pregnancy3. Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data4. Hypersensitivity to the IMP or any of its excipients (including lactose)5. Taking terazosin or other alpha adrenergic blockers (doxazosin, prazosin, tamsulosin, silodosin, trazodone, tolazoline, phentolamine, phenoxybenzamine) at time of screening visit or within the 3 months prior to baseline visit6. Ongoing use of sildenafil, tadalafil, or vardenafil7. Taking anti-coagulant medication, e.g. warfarin or apixaban8. Symptomatic postural hypotension or history of postural hypotension9. Systemic hypotension (systolic BP ≤90mmHg or diastolic BP≤60mmHg)10. History of micturition syncope11. Contraindications to lumbar puncture12. Taking part in a current CTIMP or have taken part in any CTIMP in the 3 months prior to recruitment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • John Radcliffe Hospital
    Oxford University Hospitals NHS Foundation Trust Headley Way
    Oxford
    OX3 9DU

There are potential risks associated with the blood sampling and lumbar puncture, plus the side effects of the drug (how much detail do you need?). No guaranteed direct benefit to participants, however, we hope that the results of this study will help to inform future research into treatments for ALS.

Prof Kevin Talbot
+44 (0)1865 223380
kevin.talbot@ndcn.ox.ac.uk


Dr Elizabeth Gray
+44 (0)7944 184795
elizabeth.gray@ndcn.ox.ac.uk


Miss Emma Harper
+44 (0)1865 234829
trust@ndcn.ox.ac.uk



The study is sponsored by University of Oxford and funded by My Name’5 Doddie Foundation.




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Read full details for Trial ID: ISRCTN45028842

Or CPMS 51286

Last updated 10 March 2025

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