Trial · NCT02872857
Subarachnoid Hemorrhage Recovery And Galantamine
NCT02872857, Phase 1, Phase 2, Completed, The University of Texas Health Science Center, Houston; results first posted 2021-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subarachnoid Hemorrhage Recovery And Galantamine. Trials, record NCT02872857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02872857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subarachnoid Hemorrhage Recovery And Galantamine
- NCT number
- NCT02872857
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Subarachnoid Hemorrhage
- Interventions
- Placebo, 8mg galantamine twice daily, 12mg galantamine twice daily
- First posted
- 2016-08-19
- Last updated
- 2021-10-08
- Results first posted
- 2021-10-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug | 90 days | |
| Primary | Mortality | 90 days | |
| Primary | Modified Rankin Score | 90 days | 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. |
| Secondary | Montreal Cognitive Assessment (MoCA) | 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. |
| Secondary | Montreal Cognitive Assessment (MoCA) | 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. |
| Secondary | EuroQOL Score as Assessed by a Visual Analogue Scale (VAS) | 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." |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mortality | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Modified Rankin Score | 90 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Montreal Cognitive Assessment (MoCA) | baseline (in hospital) | 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. | score on a scale | MEAN |
| SECONDARY | Montreal Cognitive Assessment (MoCA) | 90 days | 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. | score on a scale | MEAN |
| SECONDARY | EuroQOL Score as Assessed by a Visual Analogue Scale (VAS) | 90 days | 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. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug | Galantamine | 1 | Participants | ||
| Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug | Placebo | 1 | Participants | ||
| Mortality | Galantamine | 1 | Participants | ||
| Mortality | Placebo | 4 | Participants | ||
| Modified Rankin Score | Galantamine | 0 | 3 | Participants | |
| Modified Rankin Score | Placebo | 0 | 2 | Participants | |
| Modified Rankin Score | Galantamine | 1 | 8 | Participants | |
| Modified Rankin Score | Placebo | 1 | 2 | Participants | |
| Modified Rankin Score | Galantamine | 2 | 4 | Participants | |
| Modified Rankin Score | Placebo | 2 | 12 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Galantamine 8mg During Phase 1 | 15 | |
| Phase 1 | STARTED | Placebo During Phase 1 | 15 | |
| Phase 1 | STARTED | Galantamine 12mg During Phase 2 | 0 | |
| Phase 1 | STARTED | Placebo During Phase 2 | 0 | |
| Phase 1 | COMPLETED | Galantamine 8mg During Phase 1 | 15 | |
| Phase 1 | COMPLETED | Placebo During Phase 1 | 15 | |
| Phase 1 | COMPLETED | Galantamine 12mg During Phase 2 | 0 | |
| Phase 1 | COMPLETED | Placebo During Phase 2 | 0 | |
| Phase 1 | NOT COMPLETED | Galantamine 8mg During Phase 1 | 0 | |
| Phase 1 | NOT COMPLETED | Placebo During Phase 1 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Galantamine | 13 | 30 | 13 |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 12 | 30 | 12 |
| other | Hyponatremia | Metabolism and nutrition disorders | Galantamine | 12 | 30 | 12 |
| other | Hyponatremia | Metabolism and nutrition disorders | Placebo | 11 | 30 | 12 |
| other | Bradycardia | Cardiac disorders | Galantamine | 10 | 30 | 10 |
| other | Bradycardia | Cardiac disorders | Placebo | 12 | 30 | 12 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Galantamine | 7 | 30 | 9 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Placebo | 6 | 30 | 6 |
| other | Hypernatremia | Metabolism and nutrition disorders | Galantamine | 7 | 30 | 7 |
| other | Hypernatremia | Metabolism and nutrition disorders | Placebo | 11 | 30 | 11 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Galantamine | 1 | 30 |
| Total, all-cause mortality | Placebo | 4 | 30 |
| Total, other adverse events | Galantamine | 26 | 30 |
| Total, other adverse events | Placebo | 29 | 30 |
| Total, serious adverse events | Galantamine | 17 | 30 |
| Total, serious adverse events | Placebo | 17 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40877496 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Galantamine vs Placebo: Mortality | Trial comparisons |
| Galantamine vs Placebo: deaths from any cause | Trial comparisons |
| Galantamine vs Placebo: Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug | Trial comparisons |
| Galantamine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02872857
GET https://conductscience.org/api/trials/v1/NCT02872857/results?page=2