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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 8mg galantamine twice daily | Experimental |
| |
| 12mg galantamine twice daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo will match drug capsules. |
| |
| 8mg galantamine twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (in hospital) |
| Montreal Cognitive Assessment (MoCA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huimahn Choi, MD, MS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital Texas Medical Center | Houston | Texas | 77030 | United States | ||
| The University of Texas Health Science Center at Houston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40877496 | Derived | Yang BSK, Savarraj JPJ, Moreno E, Immanuel KE, Hergenroeder G, Torres G, Kim JH, Samuel S, Pedroza C, Grotta JC, Barreto A, Choi HA. SAHRANG: Subarachnoid Hemorrhage Recovery and Galantamine: A Pilot Multicenter Randomized Placebo-Controlled Trial. Neurocrit Care. 2025 Dec;43(3):986-998. doi: 10.1007/s12028-025-02349-3. Epub 2025 Aug 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Galantamine 8mg During Phase 1 | 8mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days. |
| FG001 | Placebo During Phase 1 | Placebo: Placebo will match drug capsules. |
| FG002 | Galantamine 12mg During Phase 2 | 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days. |
| FG003 | Placebo During Phase 2 | Placebo: Placebo will match drug capsules. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
| |||||||||||||
| Phase 2 |
|
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Galantamine | 8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days. |
| BG001 | Placebo | Placebo: Placebo will match drug capsules. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug | Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm. | Posted | Count of Participants | Participants | 90 days |
|
90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galantamine | 8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Cerebral Ischemia | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| HuiMahn Alex Choi, Associate Professor | The University of Texas Health Science Center at Houston | 713-500-5638 | Huimahn.A.Choi@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2018 | Jul 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
|
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.
| 90 days |
| 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." | 90 days |
| Houston |
| Texas |
| 77030 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Mortality | Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Primary | Modified Rankin Score | The Modified Rankin Score (mRS) is scored as follows: 0 - No symptoms.
| Data was not collected for 3 in the galantamine arm and 2 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | 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. | Data was not collected for 1 in the galantamine arm and 6 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | baseline (in hospital) |
|
|
|
| Secondary | 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. | Data was not collected for 6 in the galantamine arm and 6 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
|
|
| Secondary | 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." | Data was not collected for 5 in the galantamine arm and 6 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm. | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
|
|
| 1 |
| 30 |
| 17 |
| 30 |
| 26 |
| 30 |
| EG001 | Placebo | Placebo: Placebo will match drug capsules. | 4 | 30 | 17 | 30 | 29 | 30 |
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Cerebral Edema | Nervous system disorders | Systematic Assessment |
|
| Clinical Seizure | Nervous system disorders | Systematic Assessment |
|
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
|
| Angio Complication | Vascular disorders | Systematic Assessment |
|
| Surgical Complication | Surgical and medical procedures | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Univary Tract Infections | Renal and urinary disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
|
| Angio Complication | Vascular disorders | Systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Clinical Seizure | Nervous system disorders | Systematic Assessment |
|
| Pulmonary Edema | Cardiac disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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