Condition or disease | Intervention/treatment | Phase |
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Chronic Subdural Hematoma | Drug: Memantine Hydrochloride Drug: Placebo | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Pilot parallel RCT |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Only research pharmacist is unblinded. |
Primary Purpose: | Treatment |
Official Title: | Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD) |
Estimated Study Start Date : | November 1, 2021 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
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Experimental: Memantine
Subjects will be given memantine 10mg PO/ NG BID for 7 days
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Drug: Memantine Hydrochloride
Active drug arm
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Placebo Comparator: Placebo
Subjects will be given identical placebo syrup PO/NG BID for 7 days
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Drug: Placebo
Simple syrup with peppermint oil added to match the commercial solution and make it indistinguishable
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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date ICMJE | April 2, 2021 | ||||
First Posted Date ICMJE | July 19, 2021 | ||||
Last Update Posted Date | September 28, 2021 | ||||
Estimated Study Start Date ICMJE | November 1, 2021 | ||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD) | ||||
Official Title ICMJE | Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD) | ||||
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. | ||||
Detailed Description |
3.1.2. Dose Selection Rationale Memantine usually start as 5 mg and titrate up to maximum dose of 20 mg per day. In this trial we will randomize to Memantine vs Placebo with dose of 10 mg BID without titration. The lack of titration is based on the requirement for acute action rather than chronic actions over a short interval. The study by Mokhtari et al used the same approach without titration. Multiple additional studies with similar and higher dose Memantine without titration are summarized in below table. Published studies with higher dose Memantine without titration: Study Design Population Indication Dose(s) Duration Adverse Events Mokhtari, 2018 RCT Moderate TBI Neurologic Recovery 30mg PO BID (no titration) 7 days None reported (BP, temp, 02sat, serum Na, Serum glu similar between groups) Bisaga, 2001 RCT Opioid depencance Opioid physical dependance 60mg PO prior to naloxone challenge Single dose None (BP, HR, 02 sat similar. Improved withdrawal symptoms after naloxone admin) Swerdlow, 2009 RCT Normal volunteers undergoing prepulse inhibition and startle testing n/a 20 or 30mg Single dose Dizziness at 30mg (no effect of drowsiness, queasiness, autonomic measures) Hart, 2002 RCT Healthy volunteers Discrimination of methamphatamine dosing 40mg Single dose None, less irritability with memantine Collins, 2007 RCT Cocaine users Cocaine pretreatment 60mg Single dose Increased "anxious" and "stimulated" reported effects during subsequent cocaine use Handforth, 2010 Single arm pilot trial Adults with tremor Tremor reduction Up to 40mg/day 16 wk Dizziness, HA, malaise, loss of consciousness, somnolence, weight gain, poor energy, imbalance, worse tremor Ferguson, 2007 Open label study with flexible dose Major depressive disorder Depressive symptoms Up to 40mg/day 10 weeks Somnolence, dizziness, insomnia Cekman, 2011 Case report Overdose Unintended 2000mg Single dose Sleepiness and coma. Tachycardia, hypertension, respiratory alkalosis, seizure. Treated with plasmapheresis and DC home without sequelae 3.1.3. Allocation of Treatment and Randomization This is a nested Randomized Double Blinded Study within the observational study, once the SD is detected, subjects who consent will be randomized to a nested blinded pilot trial of the effect of a 7 day course of memantine 10 mg BID compared to identical placebo on both ECoG and clinical outcomes. The research pharmacist will be the only unblinded participant unless any safety concerns arise. All other study-related personnel, hospital care givers, and the patient will remain blinded. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Early Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Pilot parallel RCT Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Only research pharmacist is unblinded. Primary Purpose: Treatment
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Condition ICMJE | Chronic Subdural Hematoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2024 | ||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04966546 | ||||
Other Study ID Numbers ICMJE | 20-655 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Andrew Phillip Carlson, University of New Mexico | ||||
Study Sponsor ICMJE | University of New Mexico | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of New Mexico | ||||
Verification Date | September 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |