Subarachnoid Hemorrhage Recovery And Galantamine (SAHRANG)

The University of Texas System (UT)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Subarachnoid Hemorrhage

Treatments: Drug: Placebo; Drug: 12mg galantamine twice daily; Drug: 8mg galantamine twice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT02872857

HSC-MS-16-0228

Details and patient eligibility

About

The purpose of this study is to examine the effects of the study drug--Galantamine-on patients with subarachnoid hemorrhage (SAH). The study will examine how patients with SAH will tolerate the study drug and how it may improve brain functioning in patients after SAH.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spontaneous subarachnoid hemorrhage
• Presentation to hospital within 72 hours of symptoms
• Fisher grade 3 hemorrhage (thick subarachnoid clot) on initial computed tomography (CT) scan
• Hunt and Hess grade 1-5 at time of randomization
• Presence of a cerebral aneurysm on computed tomographic angiography (CTA) or Angiogram for which clipping or coiling is possible
• Ability to obtain medication within 36 hours of presentation

Exclusion criteria

• subarachnoid hemorrhage (SAH) due to causes other than aneurysm rupture (trauma, arteriovenous malformation (AVM), mycotic aneurysms, Moyamoya)
• Pre-existing disability with modified Rankin Scale (mRS) score ≥2,
• Renal disease as defined by creatinine clearance less than 9 milliliters/min
• History of severe hepatic impairment (Child-Pugh score of 10-15)
• History of chronic obstructive pulmonary disease (COPD) or asthma
• History of dementia
• Co-morbid conditions likely to complicate therapy, including clinically significant arrhythmia, acquired immune deficiency syndrome (AIDS), autoimmune disease, malignancy, and expected mortality within 72 hours
• Expected mortality within 72 hours as determined by PI, treating neurointensivist and neurosurgeon. (Clinically manifested by no attempt at securing aneurysm)
• Females who are pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

8mg galantamine twice daily

Experimental group

Treatment:

Drug: 8mg galantamine twice daily

12mg galantamine twice daily

Experimental group

Treatment:

Drug: 12mg galantamine twice daily