Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis (SYNAPSE-MG)

August 19, 2026 updated by: NMD Pharma A/S

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium
        • Withdrawn
        • UZ Leuven
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Josefine Nielsen
          • Phone Number: +45 23 88 25 83
          • Email: josenl@rm.dk
        • Principal Investigator:
          • Henning Andersen
      • Copenhagen, Denmark
        • Recruiting
        • Rigshospitalet University of Copenhagen
        • Contact:
        • Principal Investigator:
          • Nicolai Preisler
  • France
      • Bordeaux, France
        • Recruiting
        • Centre de référence des maladies neuromusculaires AOC-CHU de Bordeaux - Hôpital Pellegrin
        • Contact:
        • Principal Investigator:
          • Guilhem Sole
      • Marseille, France
        • Recruiting
        • Centre de Référence des Maladies Neuromusculaires et de la SLA
        • Principal Investigator:
          • Shahram ATTARIAN
        • Contact:
      • Nantes, France
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes - Hôtel Dieu Centre de Référence des Maladies Neuromusculaires Rares -
        • Principal Investigator:
          • Yann Pereon
        • Contact:
      • Nice, France
        • Recruiting
        • Chu De Nice
        • Contact:
      • Nice, France
        • Recruiting
        • Unité de Recherche Clinique NeuroSciences
        • Contact:
        • Principal Investigator:
          • Saskia Bresch
  • Georgia
      • Tbilisi, Georgia
        • Active, not recruiting
        • JSC Curatio
      • Tbilisi, Georgia
        • Active, not recruiting
        • LTD David Tatishvili Health Center
      • Tbilisi, Georgia
        • Active, not recruiting
        • LTD New Hospitals
  • Italy
      • Bergamo, Italy, 21127
        • Recruiting
        • Asst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)
        • Contact:
        • Principal Investigator:
          • Manlio Sgarzi
      • Bologna, Italy, 40139
        • Recruiting
        • IRCCS Istituo delle Scienze neurologiche di Bologna, UOC Clinica neurologica Ospedale
        • Contact:
        • Principal Investigator:
          • Prof. Rocco Liguori
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
        • Principal Investigator:
          • Dr. Marina Grandis
      • Milan, Italy, 20133
        • Recruiting
        • IRCCS Fondazione Istituto Neurologico Carlo Besta, Dipartimento di Ricerca e Sviluppo clinico
        • Contact:
        • Principal Investigator:
          • Carlo Antozzi
      • Milan, Italy
        • Recruiting
        • DIMER, IRCCS, Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Dr. Fazio Raffaella
      • Naples, Italy, 80138
        • Recruiting
        • Centro Sclerosi Multipla Napoli - AOU Vanvitelli
        • Contact:
        • Principal Investigator:
          • Alvino Bisecco
      • Pisa, Italy, 56126
        • Recruiting
        • AOU Pisana
        • Contact:
        • Principal Investigator:
          • Michelangelo Maestri Tassoni
      • Roma, Italy, 00189
        • Recruiting
        • Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza
        • Contact:
        • Principal Investigator:
          • Matteo Garibaldi
  • Netherlands
      • Leiden, Netherlands, 2333
        • Recruiting
        • Leiden Universitair Medisch Centrum (LUMC)
        • Contact:
        • Principal Investigator:
          • Jan Verschuuren
  • Poland
      • Katowice, Poland
        • Recruiting
        • Neurologia Śląska Centrum Medyczne
        • Contact:
        • Principal Investigator:
          • Dr. Marek Smilowski
      • Krakow, Poland
        • Recruiting
        • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp.z o.o
        • Principal Investigator:
          • Ryszard Nowak
        • Contact:
      • Lublin, Poland
        • Recruiting
        • Galen Clinic
        • Contact:
        • Principal Investigator:
          • Dr. Chyrchel-Paszkiewicz Urszula
      • Lublin, Poland, 20701
        • Recruiting
        • Centrum Medyczne Hope Clinic
        • Contact:
        • Principal Investigator:
          • Dr. Sebastian Szklener
      • Myślenice, Poland
        • Recruiting
        • NeuroCor Banaszkiewicz, Tomaszewski Lekarze Spółka Partnerska
        • Contact:
      • Warsaw, Poland
        • Recruiting
        • Centrum Medyczne Neuro Protect
        • Contact:
        • Principal Investigator:
          • Dr. Grudniak Mariusz
  • Serbia
      • Belgrade, Serbia
        • Withdrawn
        • University Clinical Center of Serbia, Neurology Clinic
      • Niš, Serbia
        • Recruiting
        • University Clinical Center Nis, Neurology Clinic
        • Contact:
        • Principal Investigator:
          • Gordana Djordjevic
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Raul Juntas Morales
  • United States
    • California
      • Carlsbad, California, United States, 92011
        • Withdrawn
        • Profound Research LLC
      • Irvine, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center
        • Contact:
        • Principal Investigator:
          • Ali Amer Habib
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Neuromuscular Division
        • Principal Investigator:
          • Stacy Dixon, MD
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • SFM Clinical Research, LLC
        • Principal Investigator:
          • Marc Feinberg, MD
        • Contact:
          • Gabrielle DeMaria
          • Phone Number: (561) 939-0333
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Neuromuscular Research Division | University of South Florida
        • Contact:
        • Principal Investigator:
          • Tuan H Vu
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University, Neuroscience Center
        • Contact:
        • Principal Investigator:
          • Michael Rivner
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • NextGen Precision Health
        • Contact:
        • Principal Investigator:
          • David Arnold
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • The University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • James Howard
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • The Ohio State University
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • University of Oregon
        • Contact:
        • Principal Investigator:
          • Nizar Chahin
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Withdrawn
        • Semmes Murphey Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Tablets taken twice a day for 21 days
Experimental: NMD670 high dose
Drug: NMD670
Tablets taken twice a day for 21 days
Experimental: NMD670 mid dose
Drug: NMD670
Tablets taken twice a day for 21 days
Experimental: NMD670 low dose
Drug: NMD670
Tablets taken twice a day for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious treatment emergent adverse events
Time Frame: Over 21 days of dosing
Summarised per treatment
Over 21 days of dosing
Incidence of clinically significant abnormalities on physical examinations
Time Frame: Over 21 days of dosing
Summarised per treatment
Over 21 days of dosing
Incidence of clinically significant abnormalities on safety laboratory parameters
Time Frame: Over 21 days of dosing
Summarised per treatment
Over 21 days of dosing
Incidence of clinically significant vital signs abnormalities
Time Frame: Over 21 days of dosing
Summarised per treatment
Over 21 days of dosing
Incidence of clinically significant ECG abnormalities
Time Frame: Over 21 days of dosing
Summarised per treatment
Over 21 days of dosing
Incidence of Suicidal Ideation or Suicidal Behavior
Time Frame: Over 21 days of dosing
Summarised per treatment
Over 21 days of dosing
Change from baseline to day 21 in MG-ADL total score for NMD670 vs placebo
Time Frame: Baseline to day 21
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
Time Frame: Baseline to day 21
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
Time Frame: Baseline to day 21
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
Time Frame: Baseline to day 21
Scale goes from 8-40 and higher score indicate worse symptomalogy
Baseline to day 21
Incidence of treatment emergent adverse event
Time Frame: Over 21 days of dosing
Summarised per treatment
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)
Summarised per treatment
From screening (day -28 to day -1) until follow up (day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMD Pharma A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMD670-02-0002
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2023-507539-40 (Other Identifier: EUCTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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