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Subarachnoid Hemorrhage Recovery And Galantamine (SAHRANG)

The University of Texas System (UT) logo

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

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

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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