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Amantadine

Phase 2

Traumatic Brain Injury | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Jul 15, 2025

Target and mechanism

Molecular targetGRIN1, GRIN2A, GRIN2B, GRIN2D, GRIN3B, GRIN2C
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL660

Also known as Amantadine Hydrochloride

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Amantadine · 1 trial · 1 indication

Phase 2 1
NCT06253923Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).Traumatic Brain Injury
ACTIVE NOT_RECRUITING45 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).
Traumatic Brain InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups
Day 1 to Day 35

Safety and tolerability will be compared between active treatment and placebo groups.

Secondary Endpoints

Change from baseline in Glasgow Outcome Scale-Extended
Day 21 and Day 35
Change from baseline in Disability Rating Scale (DRS) scale
Day 5, Day 10, Day 15, Day 21
Change from baseline in Coma Recovery Scale - Revised
Day 5, Day 10, Day 15, Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MR-301ACTIVE_COMPARATOROn first day, patient will receive MR-301 at 100 mg intravenous infusion BID. On second day, the dose is elevated to 150 mg intravenous infusion BID. On third day, the dose is further elevated to 200 mg intravenous infusion BID and maintained up to Day 21
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Amantadine HydrochlorideDRUGMR-301 is an I.V. formulation for the treatment of TBI. The active ingredient is amantadine hydrochloride (HCl).
PlaceboDRUGThe placebo for this study is 0.9% Sodium Chloride IV Solution.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Age: 18 to 75 years. 2. Patients with TBI confirmed by CT scan or MRI 3. Patient have sustained a trauma between 72 hours to 1 week 4. Patient with Abbreviated Injury Score (AIS) ≤ 2. 5. Patients must be admitted to an acute care setting no less than 2 days prior to randomiza...

Countries:United States
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Frequently asked questions about Amantadine

What is Amantadine used for in Traumatic Brain Injury?

Amantadine is being studied as a treatment for patients with severe Traumatic Brain Injury (TBI). It is currently in Phase 2 clinical development as an investigational small molecule therapy for this condition. The drug is being evaluated for safety in this patient population.

What does Amantadine target?

Amantadine is a small molecule being developed for Traumatic Brain Injury. The specific molecular target for this indication has not been disclosed. The drug is being studied for its potential effects in patients with severe TBI.

Who makes Amantadine?

Amantadine is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug for the treatment of severe Traumatic Brain Injury.

What phase is Amantadine in?

Amantadine is currently in Phase 2 clinical development for the treatment of severe Traumatic Brain Injury. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.

What clinical trials is Amantadine in?

Amantadine is being evaluated in a Phase 2 clinical trial with the identifier NCT06253923. This study is assessing the safety of Amantadine Hydrochloride intravenous solution in patients with severe Traumatic Brain Injury. The trial is randomized, double-blind, and placebo-controlled, with an enrollment of 45 participants in the United States.

Is Amantadine the same as Amantadine Hydrochloride?

Yes, Amantadine is the same as Amantadine Hydrochloride. The drug is referred to by both names, with Amantadine Hydrochloride being the full chemical name. In clinical trials, it is being studied as an intravenous solution for the treatment of severe Traumatic Brain Injury.