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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507539-40 | Other Identifier | EUCTR |
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This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMD670 high dose | Experimental |
| |
| NMD670 mid dose | Experimental |
| |
| NMD670 low dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMD670 | Drug | Tablets taken twice a day for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to day 21 in QMG total score for NMD670 vs placebo | Scale goes from 0-39 and higher score indicates worse symptomatology | Baseline to day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to day 21 in MG-ADL total score for NMD670 vs placebo | Scale goes from 0-24 and higher score indicates worse symptomatology | Baseline to day 21 |
| Change from baseline to day 21 in MGC total score for NMD670 vs placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NMD Pharma A/S | Contact | contact@nmdpharma.com | contact@nmdpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profound Research LLC | Withdrawn | Carlsbad | California | 92011 | United States | |
| University of California Irvine Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41224659 | Derived | Moss KR, Darvishi FB, Badawi Y, Fish LA, Funke JR, Pedersen TH, Robitaille R, Arnold WD, Burgess RW, Meriney SD, Nishimune H, Saxena S. The Neuromuscular Junction: A Shared Vulnerability in Aging and Disease. J Neurosci. 2025 Nov 12;45(46):e1353252025. doi: 10.1523/JNEUROSCI.1353-25.2025. |
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| Placebo | Drug | Tablets taken twice a day for 21 days |
|
Scale goes from 0-50 and higher score indicate worse symptomatology
| Baseline to day 21 |
| Change from baseline to day 21 in MG-QOL15r for NMD670 vs placebo | Scale goes from 0-30 and higher score indicate worse quality of life | Baseline to day 21 |
| Change from baseline to day 21 in Neuro-QoL Fatigue Short Form | Scale goes from 8-40 and higher score indicate worse symptomalogy | Baseline to day 21 |
| Incidence of treatment emergent adverse event | Summarised per treatment | Over 21 days of dosing |
| Incidence of serious treatment emergent adverse events | Summarised per treatment | Over 21 days of dosing |
| Incidence of clinically significant abnormalities on physical examinations | Summarised per treatment | Over 21 days of dosing |
| Incidence of clinically significant abnormalities on safety laboratory parameters | Summarised per treatment | Over 21 days of dosing |
| Incidence of clinically significant vital signs abnormalities | Summarised per treatment | Over 21 days of dosing |
| Incidence of clinically significant ECG abnormalities | Summarised per treatment | Over 21 days of dosing |
| Incidence of Suicidal Ideation or Suicidal Behavior | Summarised per treatment | Over 21 days of dosing |
| Incidence of clinically significant abnormalities on opthalmological examinations | Summarised per treatment | From screening (day -28 to day -1) until follow up (day 28) |
| Recruiting |
| Irvine |
| California |
| 92868 |
| United States |
|
| University of Colorado Neuromuscular Division | Recruiting | Aurora | Colorado | 80045 | United States |
|
| SFM Clinical Research, LLC | Recruiting | Boca Raton | Florida | 33487 | United States |
|
| Neuromuscular Research Division | University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
|
| Augusta University, Neuroscience Center | Recruiting | Augusta | Georgia | 30912 | United States |
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| NextGen Precision Health | Recruiting | Columbia | Missouri | 65212 | United States |
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| The University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43221 | United States |
|
| University of Oregon | Recruiting | Portland | Oregon | 97239 | United States |
|
| Semmes Murphey Clinic | Recruiting | Memphis | Tennessee | 38120 | United States |
|
| UZ Leuven | Withdrawn | Leuven | Belgium |
| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
|
| Rigshospitalet University of Copenhagen | Recruiting | Copenhagen | Denmark |
|
| Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin | Recruiting | Bordeaux | France |
|
| Centre de Référence des Maladies Neuromusculaires et de la SLA | Recruiting | Marseille | France |
|
| Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares - | Recruiting | Nantes | France |
|
| CHU de Nice | Recruiting | Nice | France |
|
| Unité de Recherche Clinique NeuroSciences | Recruiting | Nice | France |
|
| JSC Curatio | Active, not recruiting | Tbilisi | Georgia |
| LTD David Tatishvili Health Center | Active, not recruiting | Tbilisi | Georgia |
| Ltd New Hospitals | Active, not recruiting | Tbilisi | Georgia |
| ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII) | Recruiting | Bergamo | 21127 | Italy |
|
| IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale | Recruiting | Bologna | 40139 | Italy |
|
| IRCCS Ospedale Policlinico San Martino | Recruiting | Genova | 16132 | Italy |
|
| IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico | Recruiting | Milan | 20133 | Italy |
|
| DIMER, IRCCS, Ospedale San Raffaele | Recruiting | Milan | Italy |
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| Centro Sclerosi Multipla Napoli - AOU Vanvitelli | Recruiting | Naples | 80138 | Italy |
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| AOU Pisana | Recruiting | Pisa | 56126 | Italy |
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| Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza | Recruiting | Roma | 00189 | Italy |
|
| Leiden Universitair Medisch Centrum (LUMC) | Recruiting | Leiden | 2333 | Netherlands |
|
| Neurologia Śląska Centrum Medyczne | Recruiting | Katowice | Poland |
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| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o | Recruiting | Krakow | Poland |
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| Centrum Medyczne Hope Clinic | Recruiting | Lublin | 20701 | Poland |
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| Galen Clinic | Recruiting | Lublin | Poland |
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| NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska | Recruiting | Myślenice | Poland |
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| Centrum Medyczne Neuro Protect | Recruiting | Warsaw | Poland |
|
| University Clinical Center of Serbia, Neurology Clinic | Withdrawn | Belgrade | Serbia |
| University Clinical Center Nis, Neurology Clinic | Recruiting | Niš | Serbia |
|
| Hospìtal Universitari Vall d'Hebrón | Recruiting | Barcelona | Spain |
|
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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