Phase 2
Completed N=30
Subarachnoid Hemorrhage Recovery And Galantamine
Source: ClinicalTrials.gov NCT02872857 ↗Enrolled (actual)
30
Serious AEs
56.7%
Results posted
Oct 2021
Primary outcomePrimary: Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug — 1; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug |
1; 1 | — |
| PRIMARY Mortality |
1; 4 | — |
| PRIMARY Modified Rankin Score |
3; 2; 8; 2; 4; 12 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
14.0; 15.8 | — |
| SECONDARY EuroQOL Score as Assessed by a Visual Analogue Scale (VAS) |
76.2; 74.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02872857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.