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Subarachnoid Hemorrhage Recovery And Galantamine (SAHRANG)

Primary Purpose

Subarachnoid Hemorrhage

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
8mg galantamine twice daily
12mg galantamine twice daily
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Houston Methodist Hospital Texas Medical Center
  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

8mg galantamine twice daily

12mg galantamine twice daily

Arm Description

Outcomes

Primary Outcome Measures

Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug
Mortality
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.

Secondary Outcome Measures

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.
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.
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."

Full Information

First Posted
August 16, 2016
Last Updated
September 10, 2021
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02872857
Brief Title
Subarachnoid Hemorrhage Recovery And Galantamine
Acronym
SAHRANG
Official Title
A Pilot Parallel Double-Blind, Randomized Trial of Galantamine for Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
8mg galantamine twice daily
Arm Type
Experimental
Arm Title
12mg galantamine twice daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will match drug capsules.
Intervention Type
Drug
Intervention Name(s)
8mg galantamine twice daily
Intervention Description
Drug will be administered within 36 hours of hospitalization and continued for 90 days.
Intervention Type
Drug
Intervention Name(s)
12mg galantamine twice daily
Intervention Description
Drug will be administered within 36 hours of hospitalization and continued for 90 days.
Primary Outcome Measure Information:
Title
Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug
Time Frame
90 days
Title
Mortality
Time Frame
90 days
Title
Modified Rankin Score
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
baseline (in hospital)
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
90 days
Title
EuroQOL Score as Assessed by a Visual Analogue Scale (VAS)
Description
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."
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huimahn Choi, MD, MS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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