Amyotrophic lateral sclerosis Nervous System Diseases Motor neuron disease
Conditions
Interventions
Total duration of intervention and follow-up is 6 months. 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 an
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Diagnosed with ALS (Gold Coast Criteria) 4. Symptom onset (first weakness) 9-24 months (inclusive) at enrolment 5. Taking riluzole at a stable dose for at least 4 weeks prior to enrolment, or will refrain from starting riluzole for the duration of the study, or have never taken riluzole 6. Able to swallow tablets safely 7. Willing to use highly effective contraception for the duration of trial treatment and for a duration of 80 days after the last dose
Exclusion criteria
Exclusion criteria: 1. Using non-invasive ventilation (NIV) 2. Pregnancy 3. 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 data 4. 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 visit 6. Ongoing use of sildenafil, tadalafil, or vardenafil 7. Taking anti-coagulant medication, e.g. warfarin or apixaban 8. Symptomatic postural hypotension or history of postural hypotension 9. Systemic hypotension (systolic BP =90mmHg or diastolic BP=60mmHg) 10. History of micturition syncope 11. Contraindications to lumbar puncture 12. Taking part in a current CTIMP or have taken part in any CTIMP in the 3 months prior to recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma neurofilament light chain measured using ELISA assay at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CSF biomarkers measured using ELISA assay at baseline, 3 months and 6 months (neurofilament light chain, phosphorylated neurofilament heavy chain, chitotriosidase 1, chitinase 3-like protein 1, chitinase 3-like protein 2 and PGK1) 2. Plasma biomarkers measured using ELISA assay at baseline, 3 months and 6 months (neurofilament light chain and phosphorylated neurofilament heavy chain) 3. Urine biomarker measured using ELISA assay at baseline, 3 months and 6 months (Titin N-terminal fragment) 4. Functional status measured using the Revised ALS Functional Rating Scale (ALSFRS-R) score measured at baseline, 3 months and 6 months 5. Lung strength measured using Forced Vital Capacity (FVC) at baseline, 3 months and 6 months 6. Survival (data obtained by reviewing patient notes) 7. Adverse events related to IMP and proportion of patients that drop out due to adverse events (data collected from patients) | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Harper
Outcome results
None listed