Myasthenia GravisPhase 2SYNAPSE-MGNCT06414954
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
A Phase 2 study testing NMD670 in people with Myasthenia Gravis and Myasthenia Gravis, MuSK, run by NMD Pharma A/S at 40 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, Myasthenia Gravis, MuSK
- What is being tested?
- NMD670
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 40 sitesin 10 countries
- Study dates
- 16 May 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
40 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 10 countries
United States11 sites, 9 recruiting
- Recruiting
Augusta University, Neuroscience Center
Augusta, Georgia, 30912
Brandy Quarles, 706-721-0390, neuromuscular_research@augusta.edu
Michael Rivner
- Recruiting
University of Colorado Neuromuscular Division
Aurora, Colorado, 80045
Alexis Shepardson, 303-724-4644, neuroresearch@cuanschutz.edu
Stacy Dixon, MD
- Recruiting
SFM Clinical Research, LLC
Boca Raton, Florida, 33487
Gabrielle DeMaria, (561) 939-0333
Marc Feinberg, MD
- Withdrawn
Profound Research LLC
Carlsbad, California, 92011
- Recruiting
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Manisha Chopra, 1-919-843-7857, chopram@neurology.unc.edu
James Howard
- Recruiting
NextGen Precision Health
Columbia, Missouri, 65212
Neetha Gali, (573) 882-3065, ngdcd@health.missouri.edu
David Arnold
- Recruiting
The Ohio State University
Columbus, Ohio, 43221
Lischele Watkins,, MACPR, 614-293-1737, Lischele.Watkins@osumc.edu
- Recruiting
University of California Irvine Medical Center
Irvine, California, 92868
Siddhant Partap, 650-224-2637, spratap1@hs.uci.edu
Ali Amer Habib
- Withdrawn
Semmes Murphey Clinic
Memphis, Tennessee, 38120
- Recruiting
University of Oregon
Portland, Oregon, 97239
Katie Lewis, 503-494-5236, lewiskat@ohsu.edu
Nizar Chahin
- Recruiting
Neuromuscular Research Division | University of South Florida
Tampa, Florida, 33612
Jessica Shaw, 813-974-9413, jessshaw@usf.edu
Tuan H Vu
Italy8 sites, 8 recruiting
- Recruiting
ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII)
Bergamo, 21127
Manlio Sgarzi, +393356462101, msgarzi@asst-pg23.it
Manlio Sgarzi
- Recruiting
IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale
Bologna, 40139
Prof. Rocco Liguori, +390514966917, Rocco.liguori@unibo.it
Prof. Rocco Liguori
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, 16132
Dr. Marina Grandis, +390103537562, mgrandis@neurologia.unige.it
Dr. Marina Grandis
- Recruiting
IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico
Milan, 20133
Carlo Antozzi, + 39 3356157625, carlo.antozzi@istituto-besta.it
Carlo Antozzi
- Recruiting
DIMER, IRCCS, Ospedale San Raffaele
Milan
Dr.ssa Claudia Panciroli, PANCIROLI.CLAUDIA@hsr.it
Dr. Fazio Raffaella
- Recruiting
Centro Sclerosi Multipla Napoli - AOU Vanvitelli
Naples, 80138
Alvino Bisecco, +39 0815665252, alvino.bisecco@unicampania.it
Alvino Bisecco
- Recruiting
AOU Pisana
Pisa, 56126
Maestr Tassoni, + 39050995519, m.maestri@ao-pisa.toscana.it
Michelangelo Maestri Tassoni
- Recruiting
Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza
Roma, 00189
Matteo Garibaldi, +390633775937, Matteo.garibaldi@uniroma1.it
Matteo Garibaldi
Poland6 sites, 6 recruiting
- Recruiting
Neurologia Śląska Centrum Medyczne
Katowice
Marek Smilowski, +48500282494, Marek.smilowski2@gmail.com
Dr. Marek Smilowski
- Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o
Krakow
Jan Kubicki, +48 12 6468 778, badaniakliniczne@rydygierkrakow.pl
Ryszard Nowak
- Recruiting
Centrum Medyczne Hope Clinic
Lublin, 20701
Dr. Sebastian Szklener, 48 666165103, sebastianszklener@gmail.com
Dr. Sebastian Szklener
- Recruiting
Galen Clinic
Lublin
Urszula Chyrchel-Paszkiewicz, + 48602102105, pgluchyrchel@gmail.com
Dr. Chyrchel-Paszkiewicz Urszula
- Recruiting
NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska
Myślenice
Krzysztof Banaszkiewicz, +48691776505, badania@neurocor.pl
- Recruiting
Centrum Medyczne Neuro Protect
Warsaw
Grudniak Mariusz, +48 22 699 60 15, mariusz.grudniak@neuroprotect.pl
Dr. Grudniak Mariusz
France5 sites, 5 recruiting
- Recruiting
Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin
Bordeaux
Zahra Hamzi, +33 7 67 02 63 35, zahra.hamzi@chu-bordeaux.fr
Guilhem Sole
- Recruiting
Centre de Référence des Maladies Neuromusculaires et de la SLA
Marseille
Shahram Attarian, +33 0491386579, Shahram.ATTARIAN@ap-hm.fr
Shahram Attarian
- Recruiting
Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares -
Nantes
Yann Pereon, +33 2 40 08 37 04, Yann.Pereon@univ-nantes.fr
Yann Pereon
- Recruiting
CHU de Nice
Nice
Prof. Sabrina Sacconi, +33492037267, sacconi.s@chu-nice.fr
- Recruiting
Unité de Recherche Clinique NeuroSciences
Nice
Saskia Bresch, +33 04 92 03 89 05, bord.m@chu-nice.fr
Saskia Bresch
Georgia3 sites
- Active, not recruiting
JSC Curatio
Tbilisi
- Active, not recruiting
LTD David Tatishvili Health Center
Tbilisi
- Active, not recruiting
Ltd New Hospitals
Tbilisi
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Josefine Nielsen, +45 23 88 25 83, josenl@rm.dk
Henning Andersen
- Recruiting
Rigshospitalet University of Copenhagen
Copenhagen
Nicolai Preisler, +45 3545 9473, nicolai.rasmus.preisler@regionh.dk
Nicolai Preisler
Serbia2 sites, 1 recruiting
- Withdrawn
University Clinical Center of Serbia, Neurology Clinic
Belgrade
- Recruiting
University Clinical Center Nis, Neurology Clinic
Niš
Gordana Djordjevic, +381631094549, gordanadjor@gmail.com
Gordana Djordjevic
Netherlands1 site, 1 recruiting
- Recruiting
Leiden Universitair Medisch Centrum (LUMC)
Leiden, 2333
Jan Verschuuren, Myasthenie@Lumc.nl
Jan Verschuuren
Spain1 site, 1 recruiting
- Recruiting
Hospìtal Universitari Vall d'Hebrón
Barcelona
Consuelo Garcia, consuelo.garcia@vhir.org
Raul Juntas Morales
About this study
Official title: A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR/MuSK-Ab+ Myasthenia Gravis
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.
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, MuSK
- Being tested
- NMD670, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMD670Drug
Tablets taken twice a day for 21 days
PlaceboDrug
Tablets taken twice a day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| NMD670 high dose | Experimental | Not described Receives: Drug: NMD670 |
| NMD670 mid dose | Experimental | Not described Receives: Drug: NMD670 |
| NMD670 low dose | Experimental | Not described Receives: Drug: NMD670 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to day 21
Secondary outcomes (12)
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
Measured: Baseline to day 21
Change from baseline to day 21 in MGC total score for NMD670 vs placebo
Scale goes from 0-50 and higher score indicate worse symptomatology
Measured: 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
Measured: 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
Measured: Baseline to day 21
Incidence of treatment emergent adverse event
Summarised per treatment
Measured: Over 21 days of dosing
Incidence of serious treatment emergent adverse events
Summarised per treatment
Measured: Over 21 days of dosing
Incidence of clinically significant abnormalities on physical examinations
Summarised per treatment
Measured: Over 21 days of dosing
Incidence of clinically significant abnormalities on safety laboratory parameters
Summarised per treatment
Measured: Over 21 days of dosing
Incidence of clinically significant vital signs abnormalities
Summarised per treatment
Measured: Over 21 days of dosing
Incidence of clinically significant ECG abnormalities
Summarised per treatment
Measured: Over 21 days of dosing
Incidence of Suicidal Ideation or Suicidal Behavior
Summarised per treatment
Measured: Over 21 days of dosing
Incidence of clinically significant abnormalities on opthalmological examinations
Summarised per treatment
Measured: From screening (day -28 to day -1) until follow up (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start16 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NMD Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414954
- Sponsor's protocol ID
- NMD670-02-0002
- Other IDs
- 2023-507539-40, 2023
- Acronym
- SYNAPSE-MG
- Status last verified
- Nov 2025
- First submitted
- 10 May 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41224659
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR/MuSK-Ab+ Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT06414954
- Acronym / sponsor ID
- SYNAPSE-MG / NMD670-02-0002
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, MuSK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- NMD Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- 16 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NMD670 high dose | Experimental | Drug: NMD670 |
| NMD670 mid dose | Experimental | Drug: NMD670 |
| NMD670 low dose | Experimental | Drug: NMD670 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMD670Tablets taken twice a day for 21 days | Drug | NMD670 high dose, NMD670 low dose, NMD670 mid dose |
| PlaceboTablets taken twice a day for 21 days | Drug | Placebo |
Primary outcome
Change from baseline to day 21 in QMG total score for NMD670 vs placebo
Time frame: Baseline to day 21
Scale goes from 0-39 and higher score indicates worse symptomatology
12 secondary outcomes
Change from baseline to day 21 in MG-ADL total score for NMD670 vs placebo
Time frame: Baseline to day 21
Change from baseline to day 21 in MGC total score for NMD670 vs placebo
Time frame: Baseline to day 21
Change from baseline to day 21 in MG-QOL15r for NMD670 vs placebo
Time frame: Baseline to day 21
Change from baseline to day 21 in Neuro-QoL Fatigue Short Form
Time frame: Baseline to day 21
Incidence of treatment emergent adverse event
Time frame: Over 21 days of dosing
Incidence of serious treatment emergent adverse events
Time frame: Over 21 days of dosing
Incidence of clinically significant abnormalities on physical examinations
Time frame: Over 21 days of dosing
Incidence of clinically significant abnormalities on safety laboratory parameters
Time frame: Over 21 days of dosing
Incidence of clinically significant vital signs abnormalities
Time frame: Over 21 days of dosing
Incidence of clinically significant ECG abnormalities
Time frame: Over 21 days of dosing
Incidence of Suicidal Ideation or Suicidal Behavior
Time frame: Over 21 days of dosing
Incidence of clinically significant abnormalities on opthalmological examinations
Time frame: From screening (day -28 to day -1) until follow up (day 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 41224659Moss 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
40 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NMD670 in people with Myasthenia Gravis and Myasthenia Gravis, MuSK, run by NMD Pharma A/S at 40 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Italy, Poland, France, Georgia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NMD Pharma A/S (contact@nmdpharma.com, contact@nmdpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to day 21 in QMG total score for NMD670 vs placebo (time frame: Baseline to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.