NCT06414954 · NMD Pharma A/S
Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis
(SYNAPSE-MG)
What this study is about
This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and effectiveness 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.
View original scientific description
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.
Interventions
DRUG
NMD670
Tablets taken twice a day for 21 days
DRUG
Placebo
Tablets taken twice a day for 21 days
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 t
Where
- Carlsbad, California
- Irvine, California
- Aurora, Colorado
- Boca Raton, Florida
- Tampa, Florida
- Augusta, Georgia
- Columbia, Missouri
- Chapel Hill, North Carolina
- Columbus, Ohio
- Portland, Oregon
- Memphis, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations