Treatment of Amyotrophic Lateral Sclerosis with TP04HN106

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of the experimental drug TP04HN106 in patients diagnosed with amyotrophic lateral sclerosis (ALS). It employs a multicenter, randomized, double-blind, placebo-controlled design, enrolling 60 participants who will be divided into two groups: one receiving the experimental drug and the other receiving a placebo. Participants will receive intravenous injections of TP04HN106 or saline, along with standard treatment using Liraglutide tablets. The study aims to assess the drug's pharmacokinetics and overall tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;
2. Age ≥18 years old, male or female;
3. The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit subjects should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;
4. Pre-randomized subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;
5. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.

Exclusion Criteria:

1. The subject is known to be allergic to the investigational drug or its excipients;
2. The subject has a disease or injury that interferes with functional assessment or threatens life, or is accompanied by a serious irreversible disease of the heart, lung, liver, or brain, or is accompanied by a failure of different organs (for patients with respiratory failure, only patients diagnosed as type I or type II respiratory failure are excluded);
3. The subject has a major mental illness or cognitive dysfunction;
4. Patients with a history of secondary or above surgery within one month before the screening period;
5. The subjects participated in other clinical studies within 1 month;
6. The subjects are pregnant or lactating women;
7. Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion.

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Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Doctor Li, Dr
• Email: jnl@talengen-pharma.com
• Phone: 0086-89290018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.