Subarachnoid HemorrhagePhase 3NCT05131295
Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.
A Phase 3 study testing Dapsone and Aluminum Hydroxide Gel in people with Subarachnoid Hemorrhage and Brain Ischemia, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
Trial summary
Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect, making it widely available. Its neuroprotective effects have been found through its glutamate receptors antagonistic effect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage, Brain Ischemia, Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Dapsone and Aluminum Hydroxide Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteMexico
- Study dates
- 5 Sep 2007to 10 Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants presented with aneurysmal subarachnoid hemorrhage.
- Candidates to aneurysm occlusion.
- Fisher scale grade III or IV.
Who cannot join
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Anemia at admission.
- Known allergy to sulfones or sulfas.
- Severe systemic disease (renal or hepatic failure).
Trial locations and contacts
1 site in 1 country.
Mexico1 site
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Mexico City, 14269
About this study
Official title: Neuroprotective Effect of Dapsone in Patients With Aneurysmal Subarachnoid Hemorrhage: Prospective, Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial
Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect, making it widely available. Its neuroprotective effects have been found through its glutamate receptors antagonistic effect. Their main objective was to study the neuroprotective properties in patients with aneurysmal subarachnoid hemorrhage and high-risk factors for the development of cerebral vasospasm. Both the placebo and the dapsone used in this clinical trial were provided by the institution's neurochemistry laboratory.
Read the detailed description
A prospective, analytical, randomized, double-blinded, placebo-controlled clinical trial was realized. Participants suffering from aneurysmal subarachnoid hemorrhage (SAH), matching the inclusion criteria, were randomly assigned using a computer-derived table to receive from admission to the 15th day post-ictus an oral dose of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100mg per day. A nasogastric tube was used in participants with unpaired consciousness. All patients underwent aneurysm clipping or obliteration employing endovascular coils. Both groups received the standard of care (which included oral nimodipine from admission until the 21st post-ictal day, normovolemia, and dextran), and if required, vasogenic amines and/or cerebral intra-arterial administration of nimodipine in cases of cerebral vasospasm.
The participants' characteristics were assessed before the randomization process in both groups. The clinical severity was classified by the World Federation of Neurological Surgeons (WNFS), and the amount of subarachnoid blood on CT was evaluated using the Fisher scale. Patients were evaluated during their stay to look for the appearance of DCI and were followed for at least three months to evaluate their clinical outcome using the modified Rankin Scale (mRS). Severe adverse events such as methemoglobinemia and other less severe effects that forced treatment discontinuation were also assessed.
Data were analyzed according to a defined prospective plan. The primary endpoint was the incidence of DCI during the first 21 days post-SAH.
The projected sample size was 50 patients, guaranteeing a power of 80% (error β 0.2) to detect a statistically significant difference between placebo and dapsone with an accepted two-tailed α error of 0.05. The sample size was calculated assuming an incidence of DCI in the placebo group of 45% and the dapsone group of 10%, making a difference of 35% between groups.
The clinical outcome at three months and the presence of infarction on CT at patient discharge were analyzed as secondary outcomes.
Categorical variable data is presented as incidences and compare groups using the χ2 test or Fisher's exact test (when any of the cells had less than five patients). Continuous variables are presented as means and standard deviation (SD). The statistical test for these variables was the Student's t-test or nonparametric tests such as the Mann-Whitney U test.
Statistical significance with a p-value <0.05 was established and the SPSS statistical package (version 23.0) was used to perform the analysis.
- Conditions
- Subarachnoid Hemorrhage, Brain Ischemia, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Vasospasm, Cerebral
- Being tested
- Dapsone, Aluminum Hydroxide Gel
- Keywords
- Dapsone, Cerebral vasospasm, Delayed cerebral ischemia, Subarachnoid hemorrhage, Aneurysms, Neuroprotective effect
- Medical subject headings
- Subarachnoid Hemorrhage, Brain Ischemia, Vasospasm, Intracranial, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapsoneDrug
Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect. It has an anti-inflammatory effect due to its inhibitory action on neutrophils. Neuroprotective effects have been found experimentally with the use of dapsone, predominantly through its glutamate receptors antagonistic effect; these are the main receptors involved in neuronal excitotoxicity.
Aluminum Hydroxide GelDrug
Aluminum Hydroxide Gel is an antacid that works quickly to lower the acid in the stomach
| Study group | Role | What they receive |
|---|---|---|
| Dapsone | Experimental | Besides the standard of care, those assigned to the dapsone group received orally 100mg (2.5 ml) of dapsone suspension daily, from the admission day until the 15th-day post-ictus. Receives: Drug: Dapsone |
| Placebo | Placebo comparator | Besides the standard of care, those assigned to the placebo group received orally 2.5 ml of aluminum hydroxide gel daily, from the admission day until the 15th-day post-ictus. Receives: Drug: Aluminum Hydroxide Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically defined delayed cerebral ischemia
Development of focal neurological deficits or impaired consciousness with progression to stupor or coma, not explained by any other medical condition.
Measured: During the first 21 days post-ictus.
Secondary outcomes (2)
Clinical outcome at discharge and three months later
Evaluation of the clinical outcome using the modified Rankin Scale at discharge and three months follow up. Considering a cutoff point defined as favorable if lower or equal to 2 and an unfavorable if greater or equal to 3.
Measured: An average of 12 days after hospitalization and at three months follow up after discharge.
Infarction incidence demonstrated by computerized tomography (CT).
Appearance of a new localized hypodensity in a vascular distribution in the final CT prior to discharge, using validated arterial territory maps.
Measured: An average of 12 days after hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start5 Sep 2007
- Primary completion7 Dec 2008
- Study completion10 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned using a computer-derived table to receive from admission to the 15th-day post-ictus an oral dose of 2.5 ml/24 hours of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100 mg (2.5 ml/24 hours). In patients with unpaired consciousness a nasogastric tube was used. Treatment was initiated during the first five days post-ictus and continued until day 15. All patients underwent aneurysm clipping by microsurgery or obliteration employing endovascular coils; postoperatively, both groups received the usual prophylaxis (which included oral nimodipine from admission until day 21 post-ictus, normovolemia, and dextran) and/or treatment (which included the use of vasogenic amines and, in refractory cases, cerebral intra-arterial administration of nimodipine) of cerebral vasospasm.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edgar Nathal, MD, Principal investigator, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131295
- Sponsor's protocol ID
- 35/07
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD plan to protect the participants' identity.
Publications
Goddard AJ, Raju PP, Gholkar A. Does the method of treatment of acutely ruptured intracranial aneurysms influence the incidence and duration of cerebral vasospasm and clinical outcome? J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):868-72. doi: 10.1136/jnnp.2003.033068.
PubMed 15146002Ahn SH, Savarraj JP, Pervez M, Jones W, Park J, Jeon SB, Kwon SU, Chang TR, Lee K, Kim DH, Day AL, Choi HA. The Subarachnoid Hemorrhage Early Brain Edema Score Predicts Delayed Cerebral Ischemia and Clinical Outcomes. Neurosurgery. 2018 Jul 1;83(1):137-145. doi: 10.1093/neuros/nyx364.
PubMed 28973675Asano T, Takakura K, Sano K, Kikuchi H, Nagai H, Saito I, Tamura A, Ochiai C, Sasaki T. Effects of a hydroxyl radical scavenger on delayed ischemic neurological deficits following aneurysmal subarachnoid hemorrhage: results of a multicenter, placebo-controlled double-blind trial. J Neurosurg. 1996 May;84(5):792-803. doi: 10.3171/jns.1996.84.5.0792.
PubMed 8622153Bothun ML, Haaland OA, Moen G, Logallo N, Svendsen F, Thomassen L, Helland CA. Impaired cerebrovascular reactivity may predict delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2019 Dec 15;407:116539. doi: 10.1016/j.jns.2019.116539. Epub 2019 Oct 17.
PubMed 31669725Boulouis G, Labeyrie MA, Raymond J, Rodriguez-Regent C, Lukaszewicz AC, Bresson D, Ben Hassen W, Trystram D, Meder JF, Oppenheim C, Naggara O. Treatment of cerebral vasospasm following aneurysmal subarachnoid haemorrhage: a systematic review and meta-analysis. Eur Radiol. 2017 Aug;27(8):3333-3342. doi: 10.1007/s00330-016-4702-y. Epub 2016 Dec 21.
PubMed 28004163Chen J, Li M, Zhu X, Chen L, Yang S, Zhang C, Wu T, Feng X, Wang Y, Chen Q. Atorvastatin reduces cerebral vasospasm and infarction after aneurysmal subarachnoid hemorrhage in elderly Chinese adults. Aging (Albany NY). 2020 Feb 7;12(3):2939-2951. doi: 10.18632/aging.102788. Epub 2020 Feb 7.
PubMed 32035420Chugh C, Agarwal H. Cerebral vasospasm and delayed cerebral ischemia: Review of literature and the management approach. Neurol India. 2019 Jan-Feb;67(1):185-200. doi: 10.4103/0028-3886.253627.
PubMed 30860121Claassen J, Bernardini GL, Kreiter K, Bates J, Du YE, Copeland D, Connolly ES, Mayer SA. Effect of cisternal and ventricular blood on risk of delayed cerebral ischemia after subarachnoid hemorrhage: the Fisher scale revisited. Stroke. 2001 Sep;32(9):2012-20. doi: 10.1161/hs0901.095677.
PubMed 11546890Dasenbrock HH, Rudy RF, Rosalind Lai PM, Smith TR, Frerichs KU, Gormley WB, Aziz-Sultan MA, Du R. Cigarette smoking and outcomes after aneurysmal subarachnoid hemorrhage: a nationwide analysis. J Neurosurg. 2018 Aug;129(2):446-457. doi: 10.3171/2016.10.JNS16748. Epub 2017 Oct 27.
PubMed 29076779Ditz C, Leppert J, Neumann A, Krajewski KL, Gliemroth J, Tronnier VM, Kuchler J. Cerebral Vasospasm After Spontaneous Subarachnoid Hemorrhage: Angiographic Pattern and Its Impact on the Clinical Course. World Neurosurg. 2020 Jun;138:e913-e921. doi: 10.1016/j.wneu.2020.03.146. Epub 2020 Apr 2.
PubMed 32247799Fisher CM, Kistler JP, Davis JM. Relation of cerebral vasospasm to subarachnoid hemorrhage visualized by computerized tomographic scanning. Neurosurgery. 1980 Jan;6(1):1-9. doi: 10.1227/00006123-198001000-00001.
PubMed 7354892Gatti G, Hossein J, Malena M, Cruciani M, Bassetti M. Penetration of dapsone into cerebrospinal fluid of patients with AIDS. J Antimicrob Chemother. 1997 Jul;40(1):113-5. doi: 10.1093/jac/40.1.113.
PubMed 9249213Haley EC Jr, Kassell NF, Apperson-Hansen C, Maile MH, Alves WM. A randomized, double-blind, vehicle-controlled trial of tirilazad mesylate in patients with aneurysmal subarachnoid hemorrhage: a cooperative study in North America. J Neurosurg. 1997 Mar;86(3):467-74. doi: 10.3171/jns.1997.86.3.0467.
PubMed 9046304He J, Zhang X, He W, Xie Y, Chen Y, Yang Y, Chen R. Neuroprotective effects of zonisamide on cerebral ischemia injury via inhibition of neuronal apoptosis. Braz J Med Biol Res. 2021 Feb 26;54(4):e10498. doi: 10.1590/1414-431X202010498. eCollection 2021.
PubMed 33656055Hoh BL, Topcuoglu MA, Singhal AB, Pryor JC, Rabinov JD, Rordorf GA, Carter BS, Ogilvy CS. Effect of clipping, craniotomy, or intravascular coiling on cerebral vasospasm and patient outcome after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2004 Oct;55(4):779-86; discussion 786-9. doi: 10.1227/01.neu.0000137628.51839.d5.
PubMed 15458586
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effect of Dapsone in Patients With Aneurysmal Subarachnoid Hemorrhage: Prospective, Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT05131295
- Acronym / sponsor ID
- 35/07
- Conditions
- Subarachnoid Hemorrhage, Brain Ischemia, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Vasospasm, Cerebral
- Keywords
- Dapsone, Cerebral vasospasm, Delayed cerebral ischemia, Subarachnoid hemorrhage, Aneurysms, Neuroprotective effect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
- Study start
- 5 Sep 2007 (actual)
- Primary completion
- 7 Dec 2008 (actual)
- Study completion
- 10 Mar 2009 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect, making it widely available. Its neuroprotective effects have been found through its glutamate receptors antagonistic effect. Their main objective was to study the neuroprotective properties in patients with aneurysmal subarachnoid hemorrhage and high-risk factors for the development of cerebral vasospasm. Both the placebo and the dapsone used in this clinical trial were provided by the institution's neurochemistry laboratory.
Detailed description
A prospective, analytical, randomized, double-blinded, placebo-controlled clinical trial was realized. Participants suffering from aneurysmal subarachnoid hemorrhage (SAH), matching the inclusion criteria, were randomly assigned using a computer-derived table to receive from admission to the 15th day post-ictus an oral dose of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100mg per day. A nasogastric tube was used in participants with unpaired consciousness. All patients underwent aneurysm clipping or obliteration employing endovascular coils. Both groups received the standard of care (which included oral nimodipine from admission until the 21st post-ictal day, normovolemia, and dextran), and if required, vasogenic amines and/or cerebral intra-arterial administration of nimodipine in cases of cerebral vasospasm.
The participants' characteristics were assessed before the randomization process in both groups. The clinical severity was classified by the World Federation of Neurological Surgeons (WNFS), and the amount of subarachnoid blood on CT was evaluated using the Fisher scale. Patients were evaluated during their stay to look for the appearance of DCI and were followed for at least three months to evaluate their clinical outcome using the modified Rankin Scale (mRS). Severe adverse events such as methemoglobinemia and other less severe effects that forced treatment discontinuation were also assessed.
Data were analyzed according to a defined prospective plan. The primary endpoint was the incidence of DCI during the first 21 days post-SAH.
The projected sample size was 50 patients, guaranteeing a power of 80% (error β 0.2) to detect a statistically significant difference between placebo and dapsone with an accepted two-tailed α error of 0.05. The sample size was calculated assuming an incidence of DCI in the placebo group of 45% and the dapsone group of 10%, making a difference of 35% between groups.
The clinical outcome at three months and the presence of infarction on CT at patient discharge were analyzed as secondary outcomes.
Categorical variable data is presented as incidences and compare groups using the χ2 test or Fisher's exact test (when any of the cells had less than five patients). Continuous variables are presented as means and standard deviation (SD). The statistical test for these variables was the Student's t-test or nonparametric tests such as the Mann-Whitney U test.
Statistical significance with a p-value <0.05 was established and the SPSS statistical package (version 23.0) was used to perform the analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients were randomly assigned using a computer-derived table to receive from admission to the 15th-day post-ictus an oral dose of 2.5 ml/24 hours of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100 mg (2.5 ml/24 hours). In patients with unpaired consciousness a nasogastric tube was used. Treatment was initiated during the first five days post-ictus and continued until day 15. All patients underwent aneurysm clipping by microsurgery or obliteration employing endovascular coils; postoperatively, both groups received the usual prophylaxis (which included oral nimodipine from admission until day 21 post-ictus, normovolemia, and dextran) and/or treatment (which included the use of vasogenic amines and, in refractory cases, cerebral intra-arterial administration of nimodipine) of cerebral vasospasm.
| Arm | Type | Receives |
|---|---|---|
| Dapsone | Experimental | Drug: DapsoneBesides the standard of care, those assigned to the dapsone group received orally 100mg (2.5 ml) of dapsone suspension daily, from the admission day until the 15th-day post-ictus. |
| Placebo | Placebo comparator | Drug: Aluminum Hydroxide GelBesides the standard of care, those assigned to the placebo group received orally 2.5 ml of aluminum hydroxide gel daily, from the admission day until the 15th-day post-ictus. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants presented with aneurysmal subarachnoid hemorrhage.
- Candidates to aneurysm occlusion.
- Fisher scale grade III or IV.
Key exclusion criteria (4 listed)
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Anemia at admission.
- Known allergy to sulfones or sulfas.
- Severe systemic disease (renal or hepatic failure).
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 |
|---|---|---|
| DapsoneDapsone is a drug that has been used clinically for several decades due to its anti-infective effect. It has an anti-inflammatory effect due to its inhibitory action on neutrophils. Neuroprotective effects have been found experimentally with the use of dapsone, predominantly through its glutamate receptors antagonistic effect; these are the main receptors involved in neuronal excitotoxicity. | Drug | Dapsone |
| Aluminum Hydroxide GelAluminum Hydroxide Gel is an antacid that works quickly to lower the acid in the stomach | Drug | Placebo |
Primary outcome
Incidence of clinically defined delayed cerebral ischemia
Time frame: During the first 21 days post-ictus.
Development of focal neurological deficits or impaired consciousness with progression to stupor or coma, not explained by any other medical condition.
2 secondary outcomes
Clinical outcome at discharge and three months later
Time frame: An average of 12 days after hospitalization and at three months follow up after discharge.
Infarction incidence demonstrated by computerized tomography (CT).
Time frame: An average of 12 days after hospitalization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Background: PubMed 15146002Goddard AJ, Raju PP, Gholkar A. Does the method of treatment of acutely ruptured intracranial aneurysms influence the incidence and duration of cerebral vasospasm and clinical outcome? J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):868-72. doi: 10.1136/jnnp.2003.033068.
- Background: PubMed 28973675Ahn SH, Savarraj JP, Pervez M, Jones W, Park J, Jeon SB, Kwon SU, Chang TR, Lee K, Kim DH, Day AL, Choi HA. The Subarachnoid Hemorrhage Early Brain Edema Score Predicts Delayed Cerebral Ischemia and Clinical Outcomes. Neurosurgery. 2018 Jul 1;83(1):137-145. doi: 10.1093/neuros/nyx364.
- Background: PubMed 8622153Asano T, Takakura K, Sano K, Kikuchi H, Nagai H, Saito I, Tamura A, Ochiai C, Sasaki T. Effects of a hydroxyl radical scavenger on delayed ischemic neurological deficits following aneurysmal subarachnoid hemorrhage: results of a multicenter, placebo-controlled double-blind trial. J Neurosurg. 1996 May;84(5):792-803. doi: 10.3171/jns.1996.84.5.0792.
- Background: PubMed 31669725Bothun ML, Haaland OA, Moen G, Logallo N, Svendsen F, Thomassen L, Helland CA. Impaired cerebrovascular reactivity may predict delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2019 Dec 15;407:116539. doi: 10.1016/j.jns.2019.116539. Epub 2019 Oct 17.
- Background: PubMed 28004163Boulouis G, Labeyrie MA, Raymond J, Rodriguez-Regent C, Lukaszewicz AC, Bresson D, Ben Hassen W, Trystram D, Meder JF, Oppenheim C, Naggara O. Treatment of cerebral vasospasm following aneurysmal subarachnoid haemorrhage: a systematic review and meta-analysis. Eur Radiol. 2017 Aug;27(8):3333-3342. doi: 10.1007/s00330-016-4702-y. Epub 2016 Dec 21.
- Background: PubMed 32035420Chen J, Li M, Zhu X, Chen L, Yang S, Zhang C, Wu T, Feng X, Wang Y, Chen Q. Atorvastatin reduces cerebral vasospasm and infarction after aneurysmal subarachnoid hemorrhage in elderly Chinese adults. Aging (Albany NY). 2020 Feb 7;12(3):2939-2951. doi: 10.18632/aging.102788. Epub 2020 Feb 7.
- Background: PubMed 30860121Chugh C, Agarwal H. Cerebral vasospasm and delayed cerebral ischemia: Review of literature and the management approach. Neurol India. 2019 Jan-Feb;67(1):185-200. doi: 10.4103/0028-3886.253627.
- Background: PubMed 11546890Claassen J, Bernardini GL, Kreiter K, Bates J, Du YE, Copeland D, Connolly ES, Mayer SA. Effect of cisternal and ventricular blood on risk of delayed cerebral ischemia after subarachnoid hemorrhage: the Fisher scale revisited. Stroke. 2001 Sep;32(9):2012-20. doi: 10.1161/hs0901.095677.
- Background: PubMed 29076779Dasenbrock HH, Rudy RF, Rosalind Lai PM, Smith TR, Frerichs KU, Gormley WB, Aziz-Sultan MA, Du R. Cigarette smoking and outcomes after aneurysmal subarachnoid hemorrhage: a nationwide analysis. J Neurosurg. 2018 Aug;129(2):446-457. doi: 10.3171/2016.10.JNS16748. Epub 2017 Oct 27.
- Background: PubMed 32247799Ditz C, Leppert J, Neumann A, Krajewski KL, Gliemroth J, Tronnier VM, Kuchler J. Cerebral Vasospasm After Spontaneous Subarachnoid Hemorrhage: Angiographic Pattern and Its Impact on the Clinical Course. World Neurosurg. 2020 Jun;138:e913-e921. doi: 10.1016/j.wneu.2020.03.146. Epub 2020 Apr 2.
- Background: PubMed 7354892Fisher CM, Kistler JP, Davis JM. Relation of cerebral vasospasm to subarachnoid hemorrhage visualized by computerized tomographic scanning. Neurosurgery. 1980 Jan;6(1):1-9. doi: 10.1227/00006123-198001000-00001.
- Background: PubMed 9249213Gatti G, Hossein J, Malena M, Cruciani M, Bassetti M. Penetration of dapsone into cerebrospinal fluid of patients with AIDS. J Antimicrob Chemother. 1997 Jul;40(1):113-5. doi: 10.1093/jac/40.1.113.
- Individual participant dataSharing planned: No. No IPD plan to protect the participants' identity.
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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.
Edgar Nathal, MD principal investigator
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapsone and Aluminum Hydroxide Gel in people with Subarachnoid Hemorrhage and Brain Ischemia, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
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 3 inclusion and 4 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of clinically defined delayed cerebral ischemia (time frame: During the first 21 days post-ictus.). 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 NCT05131295, which also lists 46 linked publications.
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 23 Nov 2021.