Subarachnoid Hemorrhage Recovery And Galantamine
SAHRANG
A Pilot Parallel Double-Blind, Randomized Trial of Galantamine for Subarachnoid Hemorrhage
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2016
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2019
CompletedResults Posted
Study results publicly available
October 8, 2021
CompletedOctober 8, 2021
September 1, 2021
2.9 years
August 16, 2016
July 19, 2021
September 10, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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. 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.
90 days
Secondary Outcomes (3)
Montreal Cognitive Assessment (MoCA)
baseline (in hospital)
Montreal Cognitive Assessment (MoCA)
90 days
EuroQOL Score as Assessed by a Visual Analogue Scale (VAS)
90 days
Study Arms (3)
Placebo
PLACEBO COMPARATOR8mg galantamine twice daily
EXPERIMENTAL12mg galantamine twice daily
EXPERIMENTALInterventions
Drug will be administered within 36 hours of hospitalization and continued for 90 days.
Drug will be administered within 36 hours of hospitalization and continued for 90 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Houston Methodist Hospital Texas Medical Center
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- HuiMahn Alex Choi, Associate Professor
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Huimahn Choi, MD, MS
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 19, 2016
Study Start
September 1, 2016
Primary Completion
July 20, 2019
Study Completion
July 20, 2019
Last Updated
October 8, 2021
Results First Posted
October 8, 2021
Record last verified: 2021-09