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Trial record 82 of 194 for:    Hemorrhage AND SAH

Subarachnoid Hemorrhage Recovery And Galantamine (SAHRANG)

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ClinicalTrials.gov Identifier: NCT02872857
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
HuiMahn Alex Choi, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: Placebo Drug: 8mg galantamine twice daily Drug: 12mg galantamine twice daily Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Parallel Double-Blind, Randomized Trial of Galantamine for Subarachnoid Hemorrhage
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo will match drug capsules.

Experimental: 8mg galantamine twice daily Drug: 8mg galantamine twice daily
Drug will be administered within 36 hours of hospitalization and continued for 90 days.

Experimental: 12mg galantamine twice daily Drug: 12mg galantamine twice daily
Drug will be administered within 36 hours of hospitalization and continued for 90 days.




Primary Outcome Measures :
  1. Tolerability as assessed by the number of patients who stay on the study medication [ Time Frame: 90 days ]
  2. Mortality [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Modified Rankin Score [ Time Frame: 90 days ]
  2. Change in Montreal Cognitive Assessment (MoCA) [ Time Frame: baseline (in hospital), 90 days ]
  3. EuroQOL score [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872857


Contacts
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Contact: Huimahn Choi, MD, MS 713-500-5638 Huimahn.A.Choi@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Huimahn Choi, MD, MS    713-500-5638    Huimahn.A.Choi@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Huimahn Choi, MD, MS The University of Texas Health Science Center, Houston

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Responsible Party: HuiMahn Alex Choi, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02872857     History of Changes
Other Study ID Numbers: HSC-MS-16-0228
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents