Subarachnoid Hemorrhage Recovery And Galantamine

Phase 1

Completed

• Conditions: Subarachnoid Hemorrhage
• Interventions: Drug: 8mg galantamine twice daily; Drug: Placebo; Drug: 12mg galantamine twice daily

• Registration Number: NCT02872857
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2016-09
• Primary Completion: 2019-07-20
• Study Completion: 2019-07-20
• Disposition First Submitted: 2020-07-20
• Disposition First Submitted QC: 2020-07-20
• Disposition First Posted: 2020-07-21
• Results First Submitted: 2021-07-19
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Results First Posted: 2021-10-08
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8mg galantamine twice daily	8mg galantamine twice daily	-
Placebo	Placebo	-
12mg galantamine twice daily	12mg galantamine twice daily	-

Primary Outcome Measures

Name	Time	Method
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	90 days	The Modified Rankin Score (mRS) is scored as follows: 0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MoCA)	90 days	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.
EuroQOL Score as Assessed by a Visual Analogue Scale (VAS)	90 days	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."

Trial Locations

Locations (2)

Houston Methodist Hospital Texas Medical Center; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States