Clinical Trials

Amantadine hydrochloride has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to assess its efficacy in neurological and infectious indications, including Parkinson's disease, levodopa-induced dyskinesias, influenza A, glioblastoma, and fatigue associated with multiple sclerosis. Sponsored by both academic medical centers such as Johns Hopkins University and corporate entities like Adamas Pharmaceuticals and Novartis, these initiatives encompass a range of recruitment statuses, from completed studies to active recruiting cohorts and terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04302870 RECRUITING
Motor Neuron Disease, Amyotrophic Lateral Sclerosis
University of Edinburgh
 2020-02-27 PHASE2; PHASE3
NCT05140148 RECRUITING
Stroke, Ischemic; Stroke Hemorrhagic
University of Pennsylvania
 2022-02-01 PHASE2
NCT07421427 RECRUITING
Amantadine; Duloxetine; Pregabalin; Mastectomy; Pain Syndrome
Cairo University
 2026-02-21
NCT06055244 COMPLETED
Long COVID; Post-COVID19 Condition; Post-Acute COVID19 Syndrome
Ohio State University
 2023-12-07 PHASE2
NCT06234462 WITHDRAWN
Long COVID; Post-Acute COVID-19 Syndrome
University of Texas Southwestern Medical Center
 2025-06 PHASE2
NCT06253923 ACTIVE_NOT_RECRUITING
Traumatic Brain Injury
SHINKEI Therapeutics, Inc
 2024-06-01 PHASE2
NCT06052787 COMPLETED
Traumatic Brain Injury
Ain Shams University
 2023-09-01 PHASE3
NCT06817200 NOT_YET_RECRUITING
Parkinson Disease (PD)
University Hospital, Toulouse
 2025-05-01 PHASE2
NCT06833203 COMPLETED
Amantadine; Pregabalin; Post-thoracotomy Pain Syndrome
Cairo University
 2023-12-01
NCT07113015 COMPLETED
Parkinson Disease (PD); Tremor
Multan Medical And Dental College
 2024-07-05
NCT04530006 UNKNOWN
Glioblastoma Multiforme
CancerCare Manitoba
 2020-12-02
NCT05479032 UNKNOWN
Disorder of Consciousness
University Hospital Tuebingen
 2023-03-01 PHASE2
NCT05809414 UNKNOWN
Multiple Sclerosis; Fatigue
Hospital San Carlos, Madrid
 2022-11-28 PHASE3
NCT04936126 UNKNOWN
Treatment Resistant Depression
All India Institute of Medical Sciences, Bhubaneswar
 2021-08-07 PHASE4
NCT03430817 COMPLETED
Intensive Care Unit
Ain Shams University
 2017-12-07 PHASE4
NCT06443827 UNKNOWN
Amantadine; Consciousness Disorders; Electroencephalography
Azienda Sanitaria dell'Alto Adige
 2018-09-15 PHASE2
NCT04244058 SUSPENDED
Disorder of Consciousness; Traumatic Brain Injury
Weill Medical College of Cornell University
 2020-09-23 EARLY_PHASE1
NCT05667077 UNKNOWN
Post-COVID-19 Syndrome
Shahid Beheshti University of Medical Sciences
 2022-12-26 PHASE2
NCT04854759 UNKNOWN
COVID-19; SARS-CoV-2
Independent Public Clinical Hospital No. 4 in Lublin
 2021-03-15 PHASE3
NCT04952519 TERMINATED
Patients With Moderate or Severe COVID-19
Noblewell
 2021-03-30 PHASE3
NCT03612921 UNKNOWN
Intubation, Intratracheal
Assiut University
 2018-08-15 PHASE2
NCT04273737 TERMINATED
Cerebral Palsy
Columbia University
 2020-02-28 PHASE4
NCT04894617 UNKNOWN
Covid19
Copenhagen University Hospital, Hvidovre
 2021-06-01 PHASE3
NCT04527289 COMPLETED
Trauma, Brain
Damanhour University
 2020-09-30 PHASE4
NCT03527134 UNKNOWN
Postoperative Cognitive Dysfunction
Zhiyi Zuo
 2019-04-30
NCT04260581 UNKNOWN
Parkinson Disease
Seoul National University Hospital
 2020-03-01
NCT02589340 TERMINATED
Parkinson's Disease; Dyskinesias; Movement Disorders
Oregon Health and Science University
 2016-01 PHASE1
NCT04173832 UNKNOWN
L-DOPA-Induced Dyskinesia
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
 2020-01-01
NCT04530006 Recruiting
Glioblastoma Multiforme
CancerCare Manitoba|University of Manitoba|The Metabolomics Innovation Centre|BioMark Diagnostics Inc.|Canadian Institutes of Health Research (CIHR)
 2020-12-02 Not Applicable
NCT03567057 COMPLETED
Multiple Sclerosis; Walking Impairment
Adamas Pharmaceuticals, Inc.
 2018-07-18 PHASE3
NCT03178708 COMPLETED
Spinal Curvatures
Assiut University
 2017-08-01 PHASE2; PHASE3
NCT03436199 COMPLETED
Walking Impairment; Multiple Sclerosis
Adamas Pharmaceuticals, Inc.
 2018-03-29 PHASE3
NCT03988010 UNKNOWN
Postoperative Cognitive Dysfunction
TC Erciyes University
 2019-05-01 PHASE4
NCT03185065 COMPLETED
Fatigue in Multiple Sclerosis
Johns Hopkins University
 2017-10-04 PHASE3
NCT02321761 UNKNOWN
Traumatic Brain Injury
Loewenstein Hospital
 2014-06 PHASE4
NCT02486211 COMPLETED
Coma; Heart Arrest; Anoxia
Jon Rittenberger, MD
 2015-09 PHASE2
NCT03172234 COMPLETED
Effect of Laryngoscopy and Tracheal Intubation
Ghada Mohammed AboelFadl
 2017-06-15 PHASE2; PHASE3
NCT01538329 COMPLETED
Parkinson Disease
University Hospital, Toulouse
 2012-03-04 PHASE2
NCT02202551 COMPLETED
Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease (PD)
Adamas Pharmaceuticals, Inc.
 2014-07 PHASE3
NCT02566720 UNKNOWN
Acquired Brain Injury; Coma; Persistent Vegetative State; Minimally Conscious State; Traumatic Brain Injury
Hamilton Health Sciences Corporation
 2016-01
NCT01789047 TERMINATED
Idiopathic Parkinson's Disease; Drug Induced Dyskinesia
Rush University Medical Center
 2013-03 PHASE2
NCT02025439 COMPLETED
Traumatic Brain Injury
Edward Hines Jr. VA Hospital
 2014-02
NCT02471222 COMPLETED
Walking Impairment; Multiple Sclerosis
Adamas Pharmaceuticals, Inc.
 2015-05 PHASE2
NCT02153645 TERMINATED
Parkinson's Disease; Levodopa Induced Dyskinesias (LID)
Adamas Pharmaceuticals, Inc.
 2014-08-18 PHASE3
NCT02153632 TERMINATED
Parkinson's Disease; Levodopa Induced Dyskinesia (LID)
Adamas Pharmaceuticals, Inc.
 2014-07-30 PHASE3
NCT01227967 COMPLETED
Influenza
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-09 PHASE2
NCT02274766 COMPLETED
Dyskinesia; Levodopa-Induced Dyskinesia (LID); Parkinson's Disease (PD)
Adamas Pharmaceuticals, Inc.
 2014-10 PHASE3
NCT02136914 COMPLETED
Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease
Adamas Pharmaceuticals, Inc.
 2014-05 PHASE3
NCT01652534 TERMINATED
Parkinson's Disease
Northwestern University
 2011-06 PHASE3
NCT02277938 Unknown status
Cancer
University of Manitoba|BioMark Technologies Inc.|St. Boniface Hospital
 2013-08 --
NCT01397422 COMPLETED
Dyskinesia; Levodopa Induced Dyskinesia; Parkinson's Disease
Adamas Pharmaceuticals, Inc.
 2011-07 PHASE2; PHASE3
NCT00821691 COMPLETED
Cerebral Infarction
Centre Hospitalier Universitaire de Nice
 2009-03 PHASE2; PHASE3
NCT00779324 COMPLETED
Brain Injury; Aggression
Wake Forest University Health Sciences
 2009-08
NCT01313845 COMPLETED
Parkinson's Disease
Jee-Young Lee
 2011-02 PHASE4
NCT01441986 COMPLETED
Type 2 Diabetes Mellitus
Profil Institut für Stoffwechselforschung GmbH
 2011-09 PHASE2
NCT01491529 Completed
Dyskinesias|Parkinson Disease|Movement Disorders|Parkinsonian Disorders|Anti-Dyskinesia Agents
Novartis Pharmaceuticals|Novartis
 2012-04 Phase 2
NCT01071395 COMPLETED
Parkinson's Disease
Rush University Medical Center
 2010-01 PHASE4
NCT01467258 COMPLETED
Healthy Metabolism
University of Manitoba
 2011-11
NCT00975611 TERMINATED
Schizophrenia; Schizoaffective Disorder
David C. Henderson, MD
 2009-10 PHASE4
NCT00627640 COMPLETED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
 2009-02 PHASE3
NCT01313819 UNKNOWN
Parkinson's Disease; Freezing of Gait
Seoul National University Hospital
 2011-04 PHASE4
NCT01190553 UNKNOWN
Parkinson Disease
Rabin Medical Center
 2010-11
NCT01467258 Completed
Healthy Metabolism
University of Manitoba|St. Boniface Hospital
 2011-11 Not Applicable
NCT00999505 UNKNOWN
Schizophrenia
Hospital de Clinicas de Porto Alegre
 2010-05 PHASE3
NCT00600093 TERMINATED
Parkinson Disease; Perioperative Care
Rabin Medical Center
 2008-01 PHASE2
NCT00632762 COMPLETED
Parkinson's Disease
University Hospital, Toulouse
 2007-11 PHASE4
NCT00800514 WITHDRAWN
Traumatic Brain Injury
Wake Forest University Health Sciences
 2009-01
NCT00794313 TERMINATED
Parkinson's Disease
Oregon Health and Science University
 2009-09
NCT00979251 COMPLETED
Influenza
Adamas Pharmaceuticals, Inc.
 2009-09 PHASE2
NCT01099059 UNKNOWN
Attention Deficit Hyperactivity Disorder
Tehran University of Medical Sciences
 2010-04 PHASE2
NCT00970944 COMPLETED
Traumatic Brain Injury
JFK Medical Center
 2003-02 PHASE2; PHASE3
NCT00950196 COMPLETED
Ataxia; Chorea; Dystonia; Parkinsonism; Fatigue
Sheba Medical Center
 2008-11 PHASE4
NCT00287352 COMPLETED
Psychotic Disorder; Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder; Mood Disorders With Psychotic Features
University of North Carolina, Chapel Hill
 2005-05 PHASE1
NCT00867139 COMPLETED
Influenza
Fred Hutchinson Cancer Center
 2009-03 PHASE1; PHASE2
NCT00830323 TERMINATED
Influenza A Infection
Hospices Civils de Lyon
 2009-01 PHASE2
NCT00401973 COMPLETED
Schizophrenia; Schizoaffective Disorders
Eli Lilly and Company
 2006-11 PHASE3
NCT00755898 COMPLETED
Cancer
University of Manitoba
 2003-12 PHASE2
NCT00627250 COMPLETED
Irritable Mood; Aggression; Traumatic Brain Injury
Wake Forest University Health Sciences
 2003-03
NCT00693121 COMPLETED
Traumatic Brain Injury; Posttraumatic Confusional State; Delirium
Methodist Rehabilitation Center
 2003-04 PHASE4
NCT00127114 WITHDRAWN
Dementia
Johns Hopkins University
 2005-09 PHASE4
NCT00158132 COMPLETED
Cocaine-Related Disorders
University of Pennsylvania
 1999-09 PHASE2
NCT00000281 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders; Shcizophrenia
Yale University
 1994-09 PHASE2
NCT00000301 COMPLETED
Cocaine-Related Disorders
University of California, Los Angeles
 1996-03 PHASE2
NCT00015249 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 1997-02 PHASE1
NCT00127777 UNKNOWN
Hepatitis C, Chronic
University Hospital, Saarland
 2002-07 PHASE4
NCT00122629 TERMINATED
Hepatitis C, Chronic
French National Agency for Research on AIDS and Viral Hepatitis
 2000-10 PHASE3
NCT00416962 COMPLETED
Healthy
Novartis
 2006-08 PHASE1
NCT00146016 COMPLETED
Chronic Hepatitis C
UMC Utrecht
 2000-02 PHASE3
NCT00188383 UNKNOWN
Hyperalgesia; Pain; Prostate Cancer
University Health Network, Toronto
 2004-01 PHASE1; PHASE2
NCT00001930 COMPLETED
Chorea; Huntington's Disease
National Institute of Neurological Disorders and Stroke (NINDS)
 1999-04 PHASE2
NCT00538811 COMPLETED
Hepatitis C; Genotype 3; Non-responders; Relapsers
Aga Khan University
 PHASE2; PHASE3
NCT00015236 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 1997-03 PHASE4
NCT00199719 COMPLETED
Chronic Hepatitis C
University Hospital, Limoges
 2003-06 PHASE2
NCT00299923 UNKNOWN
Hepatitis C, Chronic; Relapse
University of Hamburg-Eppendorf
 2005-11 PHASE3
NCT00221624 COMPLETED
HCV Infection; Hepatitis C, Chronic
University Hospital, Bordeaux
 2001-11 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-03-04)

Check the Amantadine HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amantadine acts as an uncompetitive antagonist of N-methyl-D-aspartate glutamate receptors and a blocker of viral M2 proton channels, thereby inhibiting excessive glutamatergic signaling and viral uncoating within host cells. This dual pharmacological blockade dampens aberrant central nervous system excitation and halts viral replication, providing therapeutic relevance for mitigating levodopa-induced dyskinesia in Parkinson's disease and managing viral respiratory infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.