Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD)

NCT04966546 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 20-655
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Subdural Hematoma (cSDH) is an extremely common problem, particularly in the aging population, where fluid like collections compress the brain, frequently requiring surgical drainage. After drainage, 25-50% of patients experience post operative neurologic deficits such as weakness or confusion that are often not explained by problems such as seizure, stroke, or mass effect from the fluid and blood. Recent subdural recordings have demonstrated that some of these neurological deficits may be related to waves of spreading depolarization (SD), which cause temporary neurological dysfunction. Our overall objective is to examine the relationship between neurological deficits and SD and to assess feasibility of a pilot trial to determine if a strategy of NMDA-R antagonism can effectively reduce SD and improve clinical recovery.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (2)

• Spreading depolarizations and seizures

  Neurophysiology: spreading depolarization rate, incidence, and duration before and after memantine and between groups.

  5 days

• 90 day eGOS

  "extended Glasgow outcome scale" 1-8 ordinal scale. \* is the best.

  90 days

Secondary Outcomes (1)

• Neurological deficits: Incidence of new motor weakness or new dysphagia

  5 days

Study Arms (2)

Memantine

EXPERIMENTAL

Subjects will be given memantine 10mg PO/ NG BID for 7 days

Drug: Memantine Hydrochloride

Placebo

PLACEBO COMPARATOR

Subjects will be given identical placebo syrup PO/NG BID for 7 days

Drug: Placebo

Interventions

Memantine Hydrochloride DRUG

Active drug arm

Memantine

Placebo DRUG

Simple syrup with peppermint oil added to match the commercial solution and make it indistinguishable

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical intervention for chronic or subacute SDH
• Electrode strip placed at time of surgery (for clinical indication of enhanced seizure monitoring)
• Age 18-100
• SD detected within 48h of surgery

You may not qualify if:

• Acute SDH requiring large craniotomy (some acute subacute component within cSDH is acceptable)
• Strip not feasible or safe to place at conclusion of surgery
• Known or suspected infection
• Recurrent surgery
• Subjects who previously participated in the study (contralateral or recurrent hematoma)
• Severe renal impairment (CrCl 5-29)
• Use of other NMDA antagonist
• Severe hepatic impairment
• Child-Pugh Class C hepatic impairment
• Known allergy to memantine
• Memantine use at time of admission
• Inability to obtain enteral feeding (oral or via NGT)
• Patients on acetylcholinesterase inhibitors
• Women of child-bearing age who are unwilling to undergo dual contraception for 30 days.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Memantine

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only research pharmacist is unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot parallel RCT

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: July 19, 2021
• Study Start: June 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)