Drugs / Amantadine
Amantadine
also known as
Amantadine hydrochloride · amantadine sulfate · amantadine sulphate · AMT · PK-Merz · ADS-5102 · AMA · Amantadine HCl · +5 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | GOCOVRI | — | 2021-02-01 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | SYMMETREL | — | 1987-01-16 – 1993-04-19 | fda.gov ↗ |
| Approved | US (FDA) | SYMMETREL | — | 1968-02-14 | fda.gov ↗ |
Trials 62 · started per year
today
US approved 1968
1
2
2
1
1
2
1
2
2
2
6
4
2
1
4
2
2
2
2
2
6
3
2
4
3
1
19671968196919701971197219731974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04244058 | Sep 2020 → May 2023 | cognitive disorder, traumatic brain injury | Weill Medical College of Cornell University | Suspended | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00416962 | Aug → Dec 2006 | — | Novartis | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02696512 | Mar 2016 → Mar 2017 | brain injury | International Brain Research Foundation | Unknown | No outcome recorded |
| Phase 1/2 | NCT00867139 | Mar → Aug 2009 | influenza | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00188383 | Jan 2004 → Dec 2006 | prostate cancer | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT07125222 | Sep 2025 → Aug 2028 expected | — | Weill Medical College of Cornell University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06234462 | Jun → Sep 2025 | long COVID-19 | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT06817200 | May 2025 overdue | Parkinson disease | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06055244 | Dec 2023 → Dec 2025 | long COVID-19 | Ohio State University | Completed | No outcome recorded |
| Phase 2 | NCT05479032 | Mar 2023 → Oct 2024 | — | University Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 2 | NCT05667077 | Dec 2022 | post-COVID-19 disorder | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT06443827 | Sep 2018 → Jan 2024 | cognitive disorder | Azienda Sanitaria dell'Alto Adige | Unknown | No outcome recorded |
| Phase 2 | NCT02486211 | Sep 2015 → Jun 2018 | cardiac arrest | Jon Rittenberger, MD | Completed | No outcome recorded |
| Phase 2 | NCT02471222 | May 2015 → Jun 2016 | gait apraxia, multiple sclerosis | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01538329 | Mar 2012 → Feb 2018 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 2 | NCT01441986 | Sep 2011 → May 2012 | type 2 diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01227967 | Sep 2010 → May 2016 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01099059 | Apr 2010 | attention deficit-hyperactivity disorder | Tehran University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT00979251 | Sep 2009 → May 2010 | influenza | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00830323 | Jan → Aug 2009 | influenza | Hospices Civils de Lyon | Terminated | No outcome recorded |
| Phase 2 | NCT00600093 | Jan 2008 → Jul 2011 | Parkinson disease | Rabin Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT00158132 | Sep 1999 → Mar 2005 | cocaine dependence | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00001930 | Apr 1999 → Feb 2001 | Huntington disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00000301 | Mar 1996 → Jun 1998 | substance-related disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04302870 | Feb 2020 → Dec 2030 expected | amyotrophic lateral sclerosis | University of Edinburgh | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00970944 | Feb 2003 → Mar 2010 | traumatic brain injury | JFK Medical Center | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT06052787 | Sep 2023 → May 2025 | traumatic brain injury | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT05809414 | Nov 2022 → Jul 2024 | multiple sclerosis | Hospital San Carlos, Madrid | Unknown | No outcome recorded |
| Phase 3 | NCT04952519 | Mar 2021 → Mar 2022 | — | Noblewell | Terminated | No outcome recorded |
| Phase 3 | NCT04854759 | Mar 2021 → Mar 2022 | COVID-19 | Independent Public Clinical Hospital No. 4 in Lublin | Unknown | No outcome recorded |
| Phase 3 | NCT03436199 | Mar 2018 → Dec 2019 | multiple sclerosis | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03185065 | Oct 2017 → Nov 2019 | myalgic encephalomeyelitis/chronic fatigue syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 3 | NCT02153645 | Aug 2014 → May 2016 | Parkinson disease, drug-induced dyskinesia | Adamas Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02153632 | Jul 2014 → May 2016 | Parkinson disease, drug-induced dyskinesia | Adamas Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00401973 | Nov 2006 → Sep 2008 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00299923 | Nov 2005 → ? | chronic hepatitis C virus infection | University of Hamburg-Eppendorf | Unknown | No outcome recorded |
| Phase 3 | NCT00221624 | Nov 2001 → Apr 2004 | chronic hepatitis C virus infection | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 3 | NCT00122629 | Oct 2000 → May 2003 | chronic hepatitis C virus infection | French National Agency for Research on AIDS and Viral Hepatitis | Terminated | No outcome recorded |
| Phase 3 | NCT00146016 | Feb 2000 → Jan 2007 | chronic hepatitis C virus infection | UMC Utrecht | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT04936126 | Aug 2021 → Jul 2024 | — | All India Institute of Medical Sciences, Bhubaneswar | Unknown | No outcome recorded |
| Phase 4 | NCT04387773 | Nov 2020 → Sep 2022 | Parkinson disease | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 4 | NCT04527289 | Sep 2020 → Oct 2021 | traumatic brain injury | Damanhour University | Completed | No outcome recorded |
| Phase 4 | NCT04273737 | Feb 2020 → Feb 2022 | cerebral palsy | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT03988010 | May → Dec 2019 | — | TC Erciyes University | Unknown | No outcome recorded |
| Phase 4 | NCT03430817 | Dec 2017 → Mar 2024 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT02321761 | Jun 2014 → Dec 2018 | traumatic brain injury | Loewenstein Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01071395 | Jan 2010 → Apr 2012 | Parkinson disease | Rush University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00950196 | Nov 2008 → Nov 2009 | cerebellar ataxia, choreatic disease, dystonic disorder, parkinsonian disorder | Sheba Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00127114 | Sep 2005 → Jul 2007 | dementia | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 4 | NCT00127777 | Jul 2002 → Dec 2006 | chronic hepatitis C virus infection | University Hospital, Saarland | Unknown | No outcome recorded |
| Phase not applicable12 trials | ||||||
| — | NCT07421427 | Feb 2026 → Jan 2027 expected | chronic pain syndrome | Cairo University | Recruiting | No outcome recorded |
| — | NCT06833203 | Dec 2023 → May 2025 | — | Cairo University | Completed | No outcome recorded |
| — | NCT04260581 | Mar 2020 → Feb 2021 | Parkinson disease | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT03527134 | Apr 2019 → Jul 2021 | — | Zhiyi Zuo | Unknown | No outcome recorded |
| — | NCT02566720 | Jan → Dec 2016 | traumatic brain injury | Hamilton Health Sciences Corporation | Unknown | No outcome recorded |
| — | NCT02025439 | Feb 2014 → Jul 2016 | traumatic brain injury | Edward Hines Jr. VA Hospital | Completed | No outcome recorded |
| — | NCT01467258 | Nov 2011 → Apr 2012 | — | University of Manitoba | Completed | No outcome recorded |
| — | NCT01190553 | Nov 2010 → Dec 2011 | Parkinson disease | Rabin Medical Center | Unknown | No outcome recorded |
| — | NCT00794313 | Sep 2009 → Jun 2010 | Parkinson disease | Oregon Health and Science University | Terminated | No outcome recorded |
| — | NCT00779324 | Aug 2009 → Apr 2013 | traumatic brain injury | Wake Forest University Health Sciences | Completed | No outcome recorded |
| — | NCT00800514 | Jan 2009 → Nov 2010 | traumatic brain injury | Wake Forest University Health Sciences | Withdrawn | No outcome recorded |
| — | NCT00627250 | Mar 2003 → Nov 2007 | mood disorder, traumatic brain injury | Wake Forest University Health Sciences | Completed | No outcome recorded |
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00287352 Comparator | May 2005 → Sep 2009 | mood disorder, schizoaffective disorder, schizophrenia, schizophreniform disorder | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT00015249 Background | Feb 1997 → Apr 1998 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06253923 Comparator | Jun 2024 → Jul 2025 overdue | traumatic brain injury | SHINKEI Therapeutics, Inc | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05140148 Comparator | Feb 2022 → Dec 2027 expected | hemorrhagic stroke, ischemic stroke | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT03612921 Comparator | Aug 2018 → Mar 2022 | — | Assiut University | Unknown | No outcome recorded |
| Phase 2 | NCT01789047 Comparator | Mar 2013 → Jul 2016 | Parkinson disease, drug-induced dyskinesia | Rush University Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT00755898 Comparator | Dec 2003 → Jun 2008 | cancer | University of Manitoba | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03178708 Comparator | Aug 2017 → Dec 2019 | scoliosis | Assiut University | Completed | No outcome recorded |
| Phase 2/3 | NCT00538811 Comparator | — | hepatitis C virus infection | Aga Khan University | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04894617 Comparator | Jun 2021 → Jan 2022 | COVID-19 | Copenhagen University Hospital, Hvidovre | Unknown | No outcome recorded |
| Phase 3 | NCT01652534 Comparator | Jun 2011 → May 2015 | Parkinson disease | Northwestern University | Terminated | No outcome recorded |
| Phase 3 | NCT00999505 Comparator | May 2010 → Sep 2011 | schizophrenia | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT01313819 Comparator | Apr → Dec 2011 | Parkinson disease, primary progressive freezing gait | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01313845 Comparator | Feb 2011 → Jun 2012 | Parkinson disease | Jee-Young Lee | Completed | No outcome recorded |
| Phase 4 | NCT00975611 Comparator | Oct 2009 → Jan 2012 | schizoaffective disorder, schizophrenia | David C. Henderson, MD | Terminated | No outcome recorded |
| Phase 4 | NCT00632762 Comparator | Nov 2007 → Jan 2011 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00693121 Comparator | Apr 2003 → Nov 2007 | delirium, traumatic brain injury, traumatic encephalopathy | Methodist Rehabilitation Center | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07113015 Comparator | Jul → Dec 2024 | Parkinson disease, movement disorder | Multan Medical And Dental College | Completed | No outcome recorded |
| — | NCT04173832 Background | Jan → Dec 2020 | drug-induced dyskinesia | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 82 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amantadine | “This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of...” NCT02471222 ↗76“Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗ “This was a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 (amantadine) extended release capsules in MS subjects with walking...” NCT03436199 ↗ “A triple-combination antiviral drug (TCAD) regimen consisting of amantadine (AMT), oseltamivir (OSL) and ribavirin (RBV) demonstrated good efficacy in an animal model.” PMID 23264438 ↗ Dec 2012 “with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease” NCT00632762 ↗ “Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h” NCT00979251 ↗ “GOCOVRI (Amantadine, Extended Release Capsules)” NCT04387773 ↗ |
| Known as | ADS-5102 | “This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of...” NCT02471222 ↗ |
| Known as | AMA | “standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA)” NCT00299923 ↗ |
| Known as | Amantadine HCl | “Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.” NCT02153645 ↗ |
| Known as | Amantadine hydrochloride | “Amantadine hydrochloride 100 mg; tablets; single, oral dose.” NCT01441986 ↗5“one of them is Amantadine (Amantadine Hydrochloride) 100 mg” NCT06833203 ↗ “Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule” NCT05809414 ↗ |
| Known as | amantadine sulfate | “participants received intravenous amantadine sulfate 200 mg after induction of anesthesia and 24 hours later.” PMID 24045608 ↗ Sep 20131“Drug: Amantadine Sulfate” NCT06443827 ↗ |
| Known as | amantadine sulphate | “Patients will receive 200 mg of amantadine sulphate in a 500 ml solution every 12 hours by slow intravenous infusion over a period of 4 hours for 7 days then oral form will be used.” NCT03430817 ↗1“Amantadine Sulphate on Disorders of Consciousness” NCT06443827 ↗ |
| Known as | Amantadine, STADA Arzneimittel AG. | “Amantadine, STADA Arzneimittel AG.” NCT01441986 ↗ |
| Known as | amantidine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07125222 ↗ |
| Known as | AMT | “A triple-combination antiviral drug (TCAD) regimen consisting of amantadine (AMT), oseltamivir (OSL) and ribavirin (RBV) demonstrated good efficacy in an animal model.” PMID 23264438 ↗ Dec 20121“a single dose of amantadine (AMT), a compound that blocks NMDA-R and increases glutamate levels at the synaptic cleft” NCT04244058 ↗ |
| Known as | GOCOVRI | “The purpose of the study is to learn about the effect of GOCOVRI (Amantadine extended release) on activity levels and measures of gait and balance quality in people with...” NCT04387773 ↗ |
| Known as | MANTADIX | “Amantadine MANTADIX” NCT00632762 ↗ |
| Known as | MR-301 | “MR-301 is an I.V. formulation for the treatment of TBI.” NCT06253923 ↗ |
| Known as | PK-Merz | “PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj” NCT01313819 ↗1“one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma)” NCT07421427 ↗ |
| Action | Inhibit | “Amantadine works by attaching to special sites called NMDA (N-methyl-D-aspartate) receptors and blocking the normal activity of glutamate there.” NCT00001930 ↗ |
| Route | Oral | “oral administration of an NMDA-receptor antagonist (amantadine)” NCT00188383 ↗ |