Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.

NCT05131295 | Completed Phase 3 DMC

• 1 other identifier: 35/07
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During the first 21 days post-ictus.

Secondary Outcomes (2)

• Clinical outcome at discharge and three months later

  An average of 12 days after hospitalization and at three months follow up after discharge.

• Infarction incidence demonstrated by computerized tomography (CT).

  An average of 12 days after hospitalization.

Study Arms (2)

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.

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.

Drug: Aluminum Hydroxide Gel

Interventions

Dapsone DRUG

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.

Dapsone

Aluminum Hydroxide Gel DRUG

Aluminum Hydroxide Gel is an antacid that works quickly to lower the acid in the stomach

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants presented with aneurysmal subarachnoid hemorrhage.
• Candidates to aneurysm occlusion.
• Fisher scale grade III or IV.

You may not qualify if:

• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Anemia at admission.
• Known allergy to sulfones or sulfas.
• Severe systemic disease (renal or hepatic failure).

Sponsors & Collaborators

• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: lead

Study Sites (1)

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Mexico City, 14269, Mexico

Location

Related Publications (46)

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MeSH Terms

Conditions

Subarachnoid Hemorrhage; Brain Ischemia; Vasospasm, Intracranial; Aneurysm

Interventions

Dapsone; Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Officials

• Edgar Nathal, MD

  El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 23, 2021
• Study Start: September 5, 2007
• Primary Completion: December 7, 2008
• Study Completion: March 10, 2009
• Last Updated: November 23, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)