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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo will match drug capsules.
Experimental
8mg galantamine twice daily
  • Drug: 8mg galantamine twice daily
    Drug will be administered within 36 hours of hospitalization and continued for 90 days.
Experimental
12mg galantamine twice daily
  • Drug: 12mg galantamine twice daily
    Drug will be administered within 36 hours of hospitalization and continued for 90 days.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.