DAS-001 for Myasthenia Gravis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding ondansetron to pyridostigmine can help patients with myasthenia gravis who suffer from stomach problems caused by pyridostigmine. Pyridostigmine helps muscles work better, but it can cause nausea. Ondansetron is used to prevent this nausea. The goal is to see if patients can tolerate higher doses of pyridostigmine without feeling sick. Ondansetron is widely used to prevent nausea and vomiting in various conditions, including chemotherapy, pregnancy, and postoperative recovery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use marijuana, narcotics, aminoglycoside antibiotics, or SSRIs. You can continue taking pyridostigmine if you are already on it.
Is pyridostigmine generally safe for humans?
How does the drug pyridostigmine differ from other treatments for myasthenia gravis?
Pyridostigmine is unique because it is a cholinesterase inhibitor that increases the amount of acetylcholine (a chemical that helps muscles contract) at the neuromuscular junction, which can improve muscle strength in myasthenia gravis. However, it may not be effective for all forms of the condition and can sometimes worsen symptoms in specific cases, such as those involving anti-MuSK antibodies.12467
What data supports the effectiveness of the drug pyridostigmine for treating myasthenia gravis?
Are You a Good Fit for This Trial?
This trial is for individuals with anti-AchR antibody positive myasthenia gravis who are taking pyridostigmine and have had related GI side effects recently. Participants must be clinically stable, able to maintain a symptom diary, swallow liquids, and not have certain heart conditions or electrolyte imbalances. Pregnant women or those not using birth control, along with patients on specific medications like SSRIs or narcotics, cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either pyridostigmine with ondansetron or pyridostigmine with placebo for 6 weeks. Dose titration may occur weekly at the investigator's discretion.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in clinical evaluations.
What Are the Treatments Tested in This Trial?
Interventions
- Ondansetron
- Pyridostigmine
Pyridostigmine is already approved in United States, Canada, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
DAS-MG, Inc
Lead Sponsor