Subarachnoid Hemorrhage Recovery And Galantamine

Study Overview
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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.

Official Title
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A Pilot Parallel Double-Blind, Randomized Trial of Galantamine for Subarachnoid Hemorrhage

Conditions
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Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: Placebo
* Drug: 8mg galantamine twice daily
* Drug: 12mg galantamine twice daily


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo will match drug capsules.<br>|
| Experimental: 8mg galantamine twice daily<br> | Drug: 8mg galantamine twice daily<br>* Drug will be administered within 36 hours of hospitalization and continued for 90 days.<br>|
| Experimental: 12mg galantamine twice daily<br> | Drug: 12mg galantamine twice daily<br>* Drug will be administered within 36 hours of hospitalization and continued for 90 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug |  | 90 days | 
| Mortality |  | 90 days | 
| Modified Rankin Score | The Modified Rankin Score (mRS) is scored as follows: 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) | MoCA scores range between 0 and 30. Higher scores indicate a better outcome, and a score of 26 or over is considered to be normal. | baseline (in hospital) | 
| Montreal Cognitive Assessment (MoCA) | MoCA scores range between 0 and 30. Higher scores indicate a better outcome, and a score of 26 or over is considered to be normal. | 90 days | 
| EuroQOL Score as Assessed by a Visual Analogue Scale (VAS) | In the EuroQOL VAS assessment, health status is marked on a 20 cm vertical scale with end points of 0 and 100. 0 corresponds to  the worst health you can imagine, and 100 corresponds to the best health you can imagine. | 90 days |