Clinical Trials in France / NCT06414954
Recruiting
Phase 2
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
NCT06414954 · tracked via the Priya Life Science France tracker
Condition(s) studied
Myasthenia GravisMyasthenia Gravis, MuSK
Investigational drug(s) / intervention(s)
NMD670Placebo
NMD670: Tablets taken twice a day for 21 days
Placebo: Tablets taken twice a day for 21 days
Study summary
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.
Eligibility
Inclusion Criteria:
* Participant must be a male or female being 18 or more, at the time of signing the informed consent
* Diagnosis of MG, MGFA class II, III or IV
* Documented positive AChR or MuSK antibody test.
* Participant must be able to swallow tablets
* Body mass index between 18 and 35 kg/m2, inclusive, at screening, and with a minimum weight of 40 kg
* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Participant is capable of and has given signed informed consent
Exclusion Criteria:
* Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study
* Participants with other significant clinical and/or laboratory safety findings that may interfere with the conduction or interpretation of the study
* Participants that received treatment with an investigational medical product within 30 days or 5 half-lives of the medication, whichever is longer prior to Day 1
* Participants with history of poor compliance with relevant MG therapy
* Female patients who plan to become pregnant during the study or are currently pregnant or breastfeeding
Primary outcome measure(s)
- Change from baseline to day 21 in QMG total score for NMD670 vs placebo — Baseline to day 21
Scale goes from 0-39 and higher score indicates worse symptomatology
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| Profound Research LLC | Carlsbad | California | Withdrawn |
| University of California Irvine Medical Center | Irvine | California | Recruiting |
| University of Colorado Neuromuscular Division | Aurora | Colorado | Recruiting |
| SFM Clinical Research, LLC | Boca Raton | Florida | Recruiting |
| Neuromuscular Research Division | University of South Florida | Tampa | Florida | Recruiting |
| Augusta University, Neuroscience Center | Augusta | Georgia | Recruiting |
| NextGen Precision Health | Columbia | Missouri | Recruiting |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| The Ohio State University | Columbus | Ohio | Recruiting |
| University of Oregon | Portland | Oregon | Recruiting |
| Semmes Murphey Clinic | Memphis | Tennessee | Withdrawn |
| UZ Leuven | Leuven | Belgium | Withdrawn |
| Aarhus University Hospital | Aarhus | Denmark | Recruiting |
| Rigshospitalet University of Copenhagen | Copenhagen | Denmark | Recruiting |
| Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | France | Recruiting |
| Centre de Référence des Maladies Neuromusculaires et de la SLA | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares - | Nantes | France | Recruiting |
| CHU de Nice | Nice | France | Recruiting |
| Unité de Recherche Clinique NeuroSciences | Nice | France | Recruiting |
| JSC Curatio | Tbilisi | Georgia | Active Not Recruiting |
| LTD David Tatishvili Health Center | Tbilisi | Georgia | Active Not Recruiting |
| Ltd New Hospitals | Tbilisi | Georgia | Active Not Recruiting |
| ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII) | Bergamo | Italy | Recruiting |
| IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale | Bologna | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genova | Italy | Recruiting |
| IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico | Milan | Italy | Recruiting |
| DIMER, IRCCS, Ospedale San Raffaele | Milan | Italy | Recruiting |
| Centro Sclerosi Multipla Napoli - AOU Vanvitelli | Naples | Italy | Recruiting |
| AOU Pisana | Pisa | Italy | Recruiting |
| Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza | Roma | Italy | Recruiting |
| Leiden Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Recruiting |
| Neurologia Śląska Centrum Medyczne | Katowice | Poland | Recruiting |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o | Krakow | Poland | Recruiting |
| Centrum Medyczne Hope Clinic | Lublin | Poland | Recruiting |
| Galen Clinic | Lublin | Poland | Recruiting |
| NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska | Myślenice | Poland | Recruiting |
| Centrum Medyczne Neuro Protect | Warsaw | Poland | Recruiting |
| University Clinical Center of Serbia, Neurology Clinic | Belgrade | Serbia | Withdrawn |
| University Clinical Center Nis, Neurology Clinic | Niš | Serbia | Recruiting |
| Hospìtal Universitari Vall d'Hebrón | Barcelona | Spain | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06414954 on ClinicalTrials.gov ↗ ← All trials in France