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Cholinesterase Inhibitor

DAS-001 for Myasthenia Gravis

Phase 2
Recruiting
Research Sponsored by DAS-MG, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
GSRS rating of at least Moderate discomfort on questions 5, 11, and 12.
Be older than 18 years old
Must not have
History or presence of hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
History or presence of obstructive pulmonary disease or urinary obstruction (contraindication for pyridostigmine).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks

Summary

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.

Who is the study for?
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.
What is being tested?
The study tests DAS-001 in a phase II trial where participants receive either the test drug or a placebo without knowing which one they get. The goal is to see if DAS-001 can help manage gastrointestinal symptoms caused by pyridostigmine in people with myasthenia gravis.
What are the potential side effects?
Potential side effects may include issues similar to what's seen with pyridostigmine use such as digestive discomfort but could also involve reactions related to ondansetron-like drugs used for nausea (e.g., headaches, constipation). Specific side effect details will depend on the actual components of DAS-001.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience moderate discomfort in my stomach.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have liver, kidney, or other conditions affecting drug processing.
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I do not have a history of lung or urinary blockage.
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I am currently taking prescription pain medication.
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I am allergic to pyridostigmine or certain nausea medications.
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I am not taking aminoglycoside antibiotics due to myasthenia gravis.
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I do not have any diseases causing ongoing stomach issues like nausea or diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with change in the gastrointestinal (GI) side effects
Secondary study objectives
Number of participants with change in Electrocardiography (ECG)
Number of participants with change in in clinical laboratory evaluations
Number of participants with change in in physical examine
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: treatmentActive Control1 Intervention
ondansetron + pyridostigmine
Group II: PlaceboPlacebo Group1 Intervention
placebo+ pyridostigmine

Find a Location

Who is running the clinical trial?

DAS-MG, IncLead Sponsor
~10 spots leftby Jul 2025
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