Terazosin RepUrposing STudy in amyotrophic lateral sclerosis: a pilot study targeting PGK1 with terazosin in ALS patients

niversity of Oxford0 个研究点目标入组 50 人开始时间: 2021年12月2日最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•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

•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

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