NCT06391645Not yet recruitingPhase 2/3
Nerve Growth Factor Encapsulated With 2-methacryloyloxyethyl Phosphorylcholine Nanocapsules in the Treatment of Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov · Last updated 30 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 8 Mar 2024
- Start date
- May 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06391645
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- From May 2024 to the primary completion date, Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients participated in other clinical trials or used other biologics, drugs, or devices under study.
Other illness
- 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;
- Severe cardiac insufficiency before randomization (comply with New York College of Cardiology (NYHA) Cardiac Function Class III, IV);
- Suffering from infectious diseases: hepatitis, tuberculosis, acquired immunodeficiency syndrome, etc;
- Psychiatric disorders diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria; or with suicidal intentions;
- Combining with history of alcohol and drug abuse;
Lab values
- 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);
Other
- Patients undergoing endotracheal intubation, non-invasive or mechanical ventilation;
- Patients with diaphragmatic pacemakers;
- Women/men with desire to conceive during the experiment, and patients with pregnancy and lactation;
- Difficulty in verbal communication, inability to communicate, understand or follow instructions, inability to cooperate with treatment and evaluation;
- Unable to cooperate in follow-up due to geographical or other reasons;
Who the study is looking for
- 18-80 years old;
- Confirmed or possible familial or sporadic ALS diagnosed according to the revised El Escorial criteria;
- 6 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.