Subarachnoid Hemorrhage Recovery And Galantamine

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-07-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will match drug capsules.

8mg galantamine twice daily

Group Type EXPERIMENTAL

8mg galantamine twice daily

Intervention Type DRUG

Drug will be administered within 36 hours of hospitalization and continued for 90 days.

12mg galantamine twice daily

Group Type EXPERIMENTAL

12mg galantamine twice daily

Intervention Type DRUG

Drug will be administered within 36 hours of hospitalization and continued for 90 days.

Interventions

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Placebo

Placebo will match drug capsules.

Intervention Type DRUG

8mg galantamine twice daily

Drug will be administered within 36 hours of hospitalization and continued for 90 days.

Intervention Type DRUG

12mg galantamine twice daily

Drug will be administered within 36 hours of hospitalization and continued for 90 days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No