Subarachnoid HemorrhagePhase 1/2SAHRANGNCT02872857

Subarachnoid Hemorrhage Recovery And Galantamine

A Phase 1/2 study testing 8mg galantamine twice daily and 12mg galantamine twice daily in people with Subarachnoid Hemorrhage, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Subarachnoid Hemorrhage
What is being tested?: 8mg galantamine twice daily and 12mg galantamine twice daily
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: Sep 2016to 20 Jul 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Houston Methodist Hospital Texas Medical Center
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

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

Conditions: Subarachnoid Hemorrhage
Being tested: Placebo, 8mg galantamine twice daily, 12mg galantamine twice daily
Medical subject headings: Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo will match drug capsules.
8mg galantamine twice dailyDrug
Drug will be administered within 36 hours of hospitalization and continued for 90 days.
12mg galantamine twice dailyDrug
Drug will be administered within 36 hours of hospitalization and continued for 90 days.

Study groups in NCT02872857
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
8mg galantamine twice daily	Experimental	Not described Receives: Drug: 8mg galantamine twice daily
12mg galantamine twice daily	Experimental	Not described Receives: Drug: 12mg galantamine twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug
Measured: 90 days
Mortality
Measured: 90 days
Modified Rankin Score
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.
Measured: 90 days

Secondary outcomes (3)

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.
Measured: baseline (in hospital)
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.
Measured: 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."
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201620 Jul 2019

First posted19 Aug 2016 (estimated)
Study startSep 2016
Primary completion20 Jul 2019
Study completion20 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02872857
Sponsor's protocol ID: HSC-MS-16-0228
Acronym: SAHRANG
Status last verified: Sep 2021
First submitted: 16 Aug 2016
Last updated: 8 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 40877496

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke

All Subarachnoid Hemorrhage trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Parallel Double-Blind, Randomized Trial of Galantamine for Subarachnoid Hemorrhage
ClinicalTrials.gov ID: NCT02872857
Acronym / sponsor ID: SAHRANG / HSC-MS-16-0228
Conditions: Subarachnoid Hemorrhage
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Sep 2016
Primary completion: 20 Jul 2019 (actual)
Study completion: 20 Jul 2019 (actual)
First posted: 19 Aug 2016 (estimated)
Results: Posted 8 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
8mg galantamine twice daily	Experimental	Drug: 8mg galantamine twice daily
12mg galantamine twice daily	Experimental	Drug: 12mg galantamine twice daily

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo will match drug capsules.	Drug	Placebo
8mg galantamine twice dailyDrug will be administered within 36 hours of hospitalization and continued for 90 days.	Drug	8mg galantamine twice daily
12mg galantamine twice dailyDrug will be administered within 36 hours of hospitalization and continued for 90 days.	Drug	12mg galantamine twice daily

Primary outcome

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
Mortality
Time frame: 90 days
Modified Rankin Score
Time frame: 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.

3 secondary outcomes

Montreal Cognitive Assessment (MoCA)
Time frame: baseline (in hospital)
Montreal Cognitive Assessment (MoCA)
Time frame: 90 days
EuroQOL Score as Assessed by a Visual Analogue Scale (VAS)
Time frame: 90 days

Results and safety

Results posted to the registry on 8 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Galantamine 8mg During Phase 1	15	15
Placebo During Phase 1	15	15
Galantamine 12mg During Phase 2	0	0
Placebo During Phase 2	0	0

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Galantamine n = 30	Placebo n = 30
Value	1	1

Population analysed: 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.

Primary outcome: Mortality

Time frame: 90 days. Count of participants. Unit: Participants

Measure	Galantamine n = 30	Placebo n = 30
Value	1	4

Primary outcome: Modified Rankin Score

Time frame: 90 days. Count of participants. Unit: Participants

Measure	Galantamine n = 27	Placebo n = 28
0	3	2
1	8	2
2	4	12
3	3	3
4	4	2
5	4	3
6	1	4

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Galantamine	17 of 30 (56.7%)	26 of 30 (86.7%)	1 of 30
Placebo	17 of 30 (56.7%)	29 of 30 (96.7%)	4 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40877496Yang 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.

Related trials for Subarachnoid Hemorrhage

Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huimahn Choi, MD, MS principal investigator

The University of Texas Health Science Center, Houston

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02872857, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.