Study on the Safety and Effectiveness of NMD670 for Adults with Myasthenia Gravis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called NMD670 for patients with Myasthenia Gravis. Myasthenia Gravis is a condition that causes weakness in the muscles that control movements, often affecting the eyes, face, and swallowing. The study will test three different dose levels of NMD670, which is taken as a tablet, to see how well it works and how safe it is for patients.

The purpose of the study is to evaluate the effectiveness and safety of NMD670 over a period of 21 days. Participants will be randomly assigned to receive either NMD670 or a placebo, which looks like the real medication but does not contain the active substance. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial.

Throughout the study, participants will take the medication orally and will be monitored by healthcare professionals to assess any changes in their condition. The main goal is to observe any improvements in muscle strength and overall symptoms of Myasthenia Gravis. The study aims to provide valuable information on the potential benefits of NMD670 for managing this condition.

1 joining the study

Upon joining the study, the participant must meet specific criteria, including being between 18 and 75 years old, having a diagnosis of myasthenia gravis, and being able to swallow tablets.

Participants must agree to use effective contraception if applicable and provide informed consent.

2 randomization and treatment allocation

Participants are randomly assigned to receive either the medication NMD670 or a placebo. The study is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

3 medication administration

Participants take the assigned treatment orally in the form of a tablet. The study evaluates three different dose levels of NMD670 over a period of 21 days.

4 monitoring and assessment

Throughout the 21-day period, participants are monitored for changes in their condition. The primary measure is the change in the quantitative myasthenia gravis (QMG) total score from the start of the study to day 21.

5 completion of the study

At the end of the 21-day treatment period, participants complete the study. The data collected is used to assess the efficacy, safety, and tolerability of NMD670 compared to the placebo.

Who Can Join the Study?

  • Participant must be a male or female aged between 18 and 75 years old, including both ages, at the time of signing the informed consent.
  • Must have a diagnosis of Myasthenia Gravis (MG), specifically classified as MGFA class II, III, or IV. MGFA stands for Myasthenia Gravis Foundation of America, which classifies the severity of the condition.
  • Must have a documented positive test for AChR or MuSK antibodies. These are specific proteins in the body that can be tested to help diagnose Myasthenia Gravis.
  • Participant must be able to swallow tablets.
  • Must have a body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening, and weigh at least 40 kg. BMI is a measure that uses height and weight to estimate body fat.
  • Female participants who are WOCBP (Women of Childbearing Potential) and male participants with partners who are WOCBP must agree to use a highly effective contraception method during the study. This means using reliable birth control to prevent pregnancy.
  • Participant must be capable of and have given signed informed consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Myasthenia Gravis, a condition that causes muscle weakness.
  • Patients who are outside the age range specified for the study.
  • Patients who are not part of the clinical trial groups specified for the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Instituto Di Ricovero E Cura A Carattere Scientifico Bologna Italy
Neuroprotect Sp. z o.o. Warsaw Poland
Ospedale San Raffaele S.r.l. Milan Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Rigshospitalet Copenhagen Denmark
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Lgcqi Uazwhznekhee Mktluyn Cvrtutm (gnika Leiden The Netherlands
Nrveayxk Bxnfoljuzahwj Teqxpgwlekj Lzvtwbi szbxs Cracow Poland
Ciargsy Mwkpuozz Hlyk Clldjl Lublin Poland
Azvmckixlk Pvphrytf Hrmtroxk Dj Mzfdkdowg Marseille France
Arujwt Ureigjklvy Hwzfxazm Aarhus Denmark
Hosdipkw Vkfe dzuevnhw Barcelona Spain
Irrapquzydyn Pobfyjbs Lzwelcso Pkoif dw hvka nz mgxa Klubxn Rfdvqu Lublin Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.08.2024
Denmark Denmark
Recruiting
01.08.2024
France France
Recruiting
01.08.2024
Italy Italy
Recruiting
01.08.2024
Poland Poland
Recruiting
01.08.2024
Spain Spain
Recruiting
01.08.2024
The Netherlands The Netherlands
Recruiting
01.08.2024

Trial locations

Investigated drugs:

NMD670 is an investigational medication being studied for its potential to help patients with a condition called Myasthenia Gravis, which affects the muscles and causes weakness. This medication is being tested to see how effective it is at different dose levels over a period of 21 days. The goal is to determine if it can improve muscle strength and overall symptoms in patients with this condition.

Investigated diseases:

Myasthenia Gravis – Myasthenia Gravis is a chronic autoimmune disorder that affects the communication between nerves and muscles, leading to muscle weakness. It occurs when the immune system mistakenly attacks the connections between nerves and muscles, disrupting the transmission of nerve signals. This results in varying degrees of muscle weakness, which can fluctuate throughout the day and often worsens with activity. Commonly affected muscles include those controlling the eyes, face, and swallowing, but it can also impact limb and respiratory muscles. The severity of symptoms can vary widely among individuals, and they may improve with rest. The progression of the disease can be unpredictable, with periods of improvement and worsening.

Trial ID:
2023-507539-40-00
Protocol code:
NMD670-02-0002
Trial Phase:
Therapeutic exploratory (Phase II)

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