Health Trials

Safety and Efficacy of 3 Dose Levels of NMD670 in Adult Patients With Myasthenia Gravis

ConditionsMyasthenia GravisMyasthenia Gravis, MuSK
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNMD Pharma A/S

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NMD670

    Drug

    Tablets taken twice a day for 21 days

  • Placebo

    Drug

    Tablets taken twice a day for 21 days

Treatment groups

84 Participants
are divided into 4 treatment groups
Group A: NMD670 high doseExperimental treatment 1 intervention
Group B: NMD670 mid doseExperimental treatment 1 intervention
Group C: NMD670 low doseExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to day 21

Secondary outcomes

1

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

Time frame
Baseline to day 21
2

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

Time frame
Baseline to day 21
3

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

Time frame
Baseline to day 21
4

Change from baseline to day 21 in Neuro-QoL Fatigue Short Form

Scale goes from 8-40 and higher score indicate worse symptomalogy

Time frame
Baseline to day 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NMD Pharma A/S

Lead sponsor

Source ClinicalTrials.gov
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