Subarachnoid Hemorrhage Recovery And Galantamine

Subarachnoid Hemorrhage Clinical Trial

— SAHRANG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872857
• Other study ID #: HSC-MS-16-0228
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: July 20, 2019

Study information

• Verified date: September 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	Houston Methodist Hospital Texas Medical Center	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug		90 days
Primary	Mortality		90 days
Primary	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	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)
Secondary	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
Secondary	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