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Completed

NCT Number: NCT02872857

Subarachnoid Hemorrhage Recovery And Galantamine

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Houston Methodist Hospital Texas Medical Center, Houston, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo will match drug capsules.

8mg galantamine twice daily

Drug

Drug will be administered within 36 hours of hospitalization and continued for 90 days.

12mg galantamine twice daily

Drug

Drug will be administered within 36 hours of hospitalization and continued for 90 days.

Primary outcomes

  1. 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

  2. Mortality

    Time frame: 90 days

  3. Modified Rankin Score

    Time frame: 90 days

    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 outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: baseline (in hospital)

    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.

  2. Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  3. EuroQOL Score as Assessed by a Visual Analogue Scale (VAS)

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: SAHRANG

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2016
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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