Dalfampridine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Fampyra | — | 2011-07-20 | europa.eu ↗ |
| Approved | US (FDA) | AMPYRA | — | 2010-01-22 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05447676 | Jun 2022 → Jun 2024 | spinal cord injury | Shirley Ryan AbilityLab | Completed | No outcome recorded |
| Phase 0 | NCT04148781 | Mar 2022 → Dec 2023 | optic neuritis | Courtney Casserly | Unknown | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT07171203 | May 2026 → Jul 2030 expected | gastrointestinal stromal tumor | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 1 | NCT02868567 | Mar 2016 → Jul 2026 overdue | motor neuron disorder | Hospital for Special Surgery, New York | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01215084 | Oct → Nov 2010 | — | Biogen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06853015 | Feb 2025 → Mar 2026 overdue | spinal cord injury | Shirley Ryan AbilityLab | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01491022 | Jul 2012 → Jul 2014 | Parkinson disease | University of Miami | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT04516603 | Jan 2040 → Dec 2041 | — | University of Basel | Withdrawn | No outcome recorded |
| Phase 2 | NCT06003166 | Apr 2025 → Dec 2027 expected | crush syndrome, peripheral nerve lesion | University of Arizona | Recruiting | No outcome recorded |
| Phase 2 | NCT04652557 | Nov 2021 → Jan 2023 | — | University of Basel | Completed | No outcome recorded |
| Phase 2 | NCT03578354 | Jan 2019 → Jan 2023 | migraine disorder, vestibular disorder | Massachusetts Eye and Ear Infirmary | Withdrawn | No outcome recorded |
| Phase 2 | NCT03658408 | Oct 2018 | prostate disorder | University of Rochester | Withdrawn | No outcome recorded |
| Phase 2 | NCT02391961 | Apr 2015 → Jan 2019 | internuclear ophthalmoplegia, multiple sclerosis | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT02166346 | Feb 2014 → Jan 2017 | idiopathic acute transverse myelitis, neuromyelitis optica, transverse myelitis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT01597297 | Aug 2012 → Aug 2013 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT01621113 | Jun 2012 → Oct 2017 | spinal cord injury | Kessler Foundation | Completed | No outcome recorded |
| Phase 2 | NCT01444300 | Sep 2011 → Sep 2013 | multiple sclerosis | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT00053417 | Feb → Dec 2003 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00056810 | Sep 2002 → May 2005 | Guillain-Barre syndrome | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Phase 2 | NCT01543750 | — | episodic ataxia type 2 | University of California, Los Angeles | Withdrawn | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT04026568 | Aug 2021 → Jul 2022 | traumatic neuropathy | Milton S. Hershey Medical Center | Terminated | No outcome recorded |
| Phase 2/3 | NCT03701581 | Jun 2021 → Jul 2027 expected | prostate cancer, traumatic neuropathy | John Elfar | Recruiting | No outcome recorded |
| Phase 2/3 | NCT01667497 | Sep 2012 → Jul 2015 | — | London Health Sciences Centre | Completed | No outcome recorded |
| Phase 2/3 | NCT05859802 | Jul 2011 → Mar 2015 | multiple sclerosis | D'Youville College | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07185347 | Oct 2025 → May 2027 expected | spinocerebellar ataxia 27B, late-onset | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT02219932 | Sep 2014 → Feb 2016 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01917019 | Aug 2013 → Oct 2015 | primary progressive multiple sclerosis, progressive relapsing multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01235221 | Dec 2010 → Jun 2012 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00649792 | Aug 2007 → Jan 2011 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00648908 | Jun 2006 → Jan 2011 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00127530 | May 2005 → Jun 2006 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00654927 | Nov 2003 → Jan 2011 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT02208050 | Feb 2014 → Feb 2016 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | University College Dublin | Completed | No outcome recorded |
| Phase 4 | NCT02849782 | Feb 2014 → Mar 2019 | multiple sclerosis | Centre Hospitalier Universitaire de Besancon | Completed | No outcome recorded |
| Phase 4 | NCT02146534 | Dec 2013 → Jan 2016 | multiple sclerosis | Clinique Neuro-Outaouais | Completed | No outcome recorded |
| Phase 4 | NCT01975324 | Jul 2013 → Dec 2015 | non-arteritic anterior ischemic optic neuropathy | Neuro-Ophthalmologic Associates, PC | Completed | No outcome recorded |
| Phase 4 | NCT01656148 | Jun 2012 → May 2014 | multiple sclerosis | University of Southern Denmark | Completed | No outcome recorded |
| Phase 4 | NCT01480076 | Feb 2012 → Jul 2013 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07532460 | Apr 2026 → Aug 2027 expected | cognitive disorder, substance-related disorder | Boris Quednow | Not yet recruiting | No outcome recorded |
| — | NCT05274477 | Jun 2022 → Jun 2024 | post-COVID-19 disorder | University of Basel | Terminated | No outcome recorded |
| — | NCT05613114 | Aug 2020 → Mar 2021 | hereditary spastic paraplegia | European University of Lefke | Completed | No outcome recorded |
| — | NCT03847545 | Dec 2018 → Oct 2021 | multiple sclerosis | University of Southern Denmark | Completed | No outcome recorded |
| — | NCT01811706 | Feb → Dec 2013 | Machado-Joseph disease, spinocerebellar ataxia type 1, spinocerebellar ataxia type 2, spinocerebellar ataxia type 6 | University of Florida | Completed | No outcome recorded |
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01468350 Comparator | Dec 2011 → Jan 2013 | cerebral palsy | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01316055 Comparator | Jan → Aug 2011 | impaired renal function disease | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06294821 Comparator | Nov 2026 → Dec 2027 expected | carpal tunnel syndrome | John Elfar | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06596434 Comparator | Jan 2026 → Jun 2028 expected | — | John Elfar | Recruiting | No outcome recorded |
| Phase 2 | NCT06333171 Comparator | Sep 2025 → Sep 2027 expected | — | John Elfar | Recruiting | No outcome recorded |
| Phase 2 | NCT06751784 Comparator | May 2025 → Jul 2026 overdue | major depressive disorder | University of Basel | Recruiting | No outcome recorded |
| Phase 2 | NCT02656160 Comparator | Jan → May 2016 | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02280096 Comparator | Oct 2014 → Feb 2016 | multiple sclerosis | Coordinación de Investigación en Salud, Mexico | Completed | No outcome recorded |
| Phase 2 | NCT01605825 Comparator | May 2012 → Feb 2013 | ischemic stroke | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01576354 Comparator | Mar 2012 → Apr 2017 | multiple sclerosis | University of Zurich | Unknown | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT01645787 Comparator | Jun 2012 → Sep 2015 | spinal muscular atrophy | Columbia University | Completed | No outcome recorded |
| Phase 2/3 | NCT02006160 Comparator | Dec 2011 → Feb 2016 | multiple sclerosis | State University of New York at Buffalo | Completed | No outcome recorded |
| Phase 2/3 | NCT01337986 Comparator | May 2011 → Dec 2013 | multiple sclerosis, optic neuritis | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT06136728 Comparator | Jun 2024 → Dec 2026 expected | multiple sclerosis | MGH Institute of Health Professions | Recruiting | No outcome recorded |
| Phase 3 | NCT03899584 Comparator | Jul 2019 → Dec 2022 | spinal cord injury | Coordinación de Investigación en Salud, Mexico | Unknown | No outcome recorded |
| Phase 3 | NCT02422940 Comparator | Apr 2015 → Jan 2017 | ischemic stroke | Acorda Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT02271217 Comparator | Dec 2014 → Sep 2016 | ischemic stroke | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01328379 Comparator | Mar 2011 → Apr 2012 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00483652 Comparator | May 2007 → Feb 2008 | multiple sclerosis | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00041717 Comparator | Jul 2002 → Feb 2004 | spinal cord injury | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT01683838 Comparator | Jun 2002 → Nov 2003 | spinal cord injury | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02259361 Comparator | Nov 2014 | multiple sclerosis | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01356940 Comparator | Nov 2010 → Apr 2013 | multiple sclerosis | Brown, Theodore R., M.D., MPH | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05730738 Comparator | Jun 2021 → Dec 2023 | multiple sclerosis | Ain Shams University | Unknown | No outcome recorded |
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 73 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dalfampridine | “The proposed version of the drug used in this study is an extended release formulation of 4-AP, called dalfampridine, which was marketed under the trade name AMPYRA, by Acorda...” NCT04026568 ↗25“Recently, dalfampridine, an extended release formulation of 4AP (AMPYRA) by Acorda Therapeutics, received FDA approval to improve gait in multiple sclerosis.” NCT01543750 ↗ |
| Known as | 4-aminopyridine | “Hence, to confirm the beneficial effect of 4-aminopyridine treatment, this study will compare fampridine 10 mg bid (sustained-release form) to placebo during a 3-month...” NCT07185347 ↗24“In the present study, we aim at investigating the effects of 10 mg fampridine (4-Aminopyridine), a potassium channel-blocking agent, on working memory performance in...” NCT05274477 ↗ “Studies have shown that MS symptomatic treatment by fampridine (4-aminopyridine) is associated with improvements in walking and muscle strength and possibly with cognition,...” NCT02849782 ↗ “The Effect of Dalfampridine (4-aminopyridine) on Genioglossus Muscle Activity During Wakefulness and Sleep in Healthy Control Subjects” NCT02656160 ↗ “BACKGROUND: Clinical studies suggested that fampridine (4-aminopyridine) improves motor function in people with multiple sclerosis.” PMID 19249634 ↗ Feb 2009 “Extended release dalfampridine (also known as fampridine or 4-aminopyridine \[4-AP\]) is a broad spectrum potassium channel blocker” NCT01621113 ↗ “The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP).” NCT05730738 ↗ “Prolonged-release fampridine (4-aminopyridine) is a voltage-gated potassium channel blocking agent.” NCT02146534 ↗ “Treatment with fampridine (4-aminopyridine), a potassium channel blocker” NCT02208050 ↗ “Fampridine-SR (4-aminopyridine) is a slow release oral medication” NCT01667497 ↗ “10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)” NCT00053417 ↗ |
| Known as | 4-AP | “This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of...” NCT03578354 ↗8“Recently, dalfampridine, an extended release formulation of 4AP (AMPYRA) by Acorda Therapeutics, received FDA approval to improve gait in multiple sclerosis.” NCT01543750 ↗ “The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy.” NCT03658408 ↗ “Extended release dalfampridine (also known as fampridine or 4-aminopyridine \[4-AP\]) is a broad spectrum potassium channel blocker” NCT01621113 ↗ “The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP).” NCT05730738 ↗ “immediate release formulation of 4-AP, sometimes called fampridine” NCT04026568 ↗ “10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)” NCT00053417 ↗ “4-aminopyridine (4-AP)” NCT00056810 ↗ “4-aminopyridine (4-AP)” NCT07532460 ↗ |
| Known as | AMPYRA | “The proposed version of the drug used in this study is an extended release formulation of 4-AP, called dalfampridine, which was marketed under the trade name AMPYRA, by Acorda...” NCT04026568 ↗3“Recently, dalfampridine, an extended release formulation of 4AP (AMPYRA) by Acorda Therapeutics, received FDA approval to improve gait in multiple sclerosis.” NCT01543750 ↗ “Fampridine, Dalfampridine, Ampyra” NCT01328379 ↗ |
| Known as | Ampyra extended release | ChEMBL registry synonym — accepted as the source's own label CHEMBL284348 ↗ |
| Known as | BIIB041 | “BIIB041 (Fampridine-SR)” NCT01235221 ↗ |
| Known as | D-ER | “The goal of this study was to evaluate the safety and tolerability of dalfampridine extended release (D-ER) in a pilot study of adults with cerebral palsy (CP) and limited...” PMID 28131322 ↗ Jan 20171“Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.” PMID 32651338 ↗ 2020 |
| Known as | Dalfampridine-ER | “Dalfampridine-ER 5mg” NCT01328379 ↗ |
| Known as | EL-970 | ChEMBL registry synonym — accepted as the source's own label CHEMBL284348 ↗ |
| Known as | extended release fampridine | “extended release fampridine 10mg BID PO for 14 weeks” NCT02146534 ↗ |
| Known as | Fampridina | ChEMBL registry synonym — accepted as the source's own label CHEMBL284348 ↗ |
| Known as | fampridine | “Extended release dalfampridine (also known as fampridine or 4-aminopyridine \[4-AP\]) is a broad spectrum potassium channel blocker” NCT01621113 ↗24“The only approved treatment for impaired ambulation in MS is Dalfampridine (also known as fampridine, 4-aminopyridine, 4-AP).” NCT05730738 ↗ “immediate release formulation of 4-AP, sometimes called fampridine” NCT04026568 ↗ |
| Known as | Fampridine (4-aminopyridine) | ChEMBL registry synonym — accepted as the source's own label CHEMBL284348 ↗ |
| Known as | Fampridine accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL284348 ↗ |
| Known as | fampridine prolonged-release (PR) | “A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants” NCT01215084 ↗ |
| Known as | Fampridine-PR | “BIIB041 (Fampridine-PR)” NCT01215084 ↗ |
| Known as | Fampridine-SR | “Active study medication consists of 15 tablets of fampridine SR 10 mg formulated for oral administration taken in the morning and evening 12 h apart without food.” NCT06751784 ↗10“Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses.” NCT01683838 ↗ “Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks.” NCT01656148 ↗ “10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)” NCT00053417 ↗ “BIIB041 (Fampridine-SR)” NCT01235221 ↗ “Drug: Fampridine-SR” NCT00127530 ↗ |
| Known as | Fampridine-Sustained Release (SR) | “Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury” NCT01683838 ↗ |
| Known as | Fampyra | “Fampridine, especially its slow-release formulation (Fampyra®) is generally a safe drug with well-studied pharmacokinetic properties.” NCT05274477 ↗1“Twice daily oral administration of 10 mg fampridine (Fampyra®) for 7.5 days with a wash-out period of at least 6.5 days” NCT06751784 ↗ |
| Known as | NSC-15041 | ChEMBL registry synonym — accepted as the source's own label CHEMBL284348 ↗ |
| Known as | PRF | “BACKGROUND: Both prolonged-release fampridine (PRF) and enabling active motor training (EAMT) are beneficial in multiple sclerosis (MS) patients.” PMID 29552356 ↗ Mar 2018 |
| Known as | prolonged-release fampridine | “Prolonged-release fampridine (4-aminopyridine) is a voltage-gated potassium channel blocking agent.” NCT02146534 ↗ |
| Known as | slow-release Fampridine | “The objectives of this study were 1) to examine the effect of SR-Fampridine treatment on muscle strength in terms of maximal voluntary contraction (MVC) and rate of force...” PMID 27919481 ↗ Sep 2016 |
| Known as | SR Fampridine | “The objectives of this study were 1) to examine the effect of SR-Fampridine treatment on muscle strength in terms of maximal voluntary contraction (MVC) and rate of force...” PMID 27919481 ↗ Sep 2016 |
| Action | Inhibit | “4-aminopyridine (4-AP) in those patients who suffer chronic functional deficits from GBS.This medication is a potassium channel blocker” NCT00056810 ↗ |
| Modality | Small molecule | — CHEMBL284348 ↗ |
| Route | Oral | “Oral Fampridine-SR” NCT00041717 ↗ |