NCT06391645
Nerve Growth Factor Encapsulated With 2-methacryloyloxyethyl Phosphorylcholine Nanocapsules in the Treatment of Amyotrophic Lateral Sclerosis
Not Yet Recruiting · Phase 2, Phase 3 · Beijing Tiantan Hospital · registry updated 2024-04-30
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Amyotrophic lateral sclerosis (ALS) is one of the most lethal neurodegenerative diseases, with most patients dying from respiratory failure 3-5 years after the onset. The purpose of this study is to explore the efficacy and safety of nerve growth factor (NGF) encapsulated with 2-methacryloyloxyethyl phosphorylcholine (MPC) nanocapsules in the treatment of ALS patients.
Inclusion
- Confirmed or possible familial or sporadic ALS diagnosed according to the revised El Escorial criteria;
- months ≤disease duration ≤ 3 years, (onset time is defined as the time of the first occurrence of myasthenia);
- Forced vital capacity (FVC) ≥ 85% of predicted value (based on gender, height and age);
- Informed consent signed.
Exclusion
- Patients undergoing endotracheal intubation, non-invasive or mechanical ventilation;
- Patients with diaphragmatic pacemakers;
- Allergy to any component of the investigational medication, or any other allergic history that researchers deem necessary to be vigilant about;
- Local skin infection or other suspicious signs of infection at the injection site;
- Known hemorrhagic tendency (including but not limited to: platelet count \<100×109/ L; on therapy of heparin, activated partial thromboplastin time (APTT) ≥35s; on therapy of warfarin, international normalized ratio (INR) \>1.7; on therapy of novel oral anticoagulants; with direct thrombin or factor Xa inhibitor; accompanied with coagulopathy such as hemophilia);
- Severe cardiac insufficiency before randomization (comply with New York College of Cardiology (NYHA) Cardiac Function Class III, IV);