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New treatment option for Amyotrophic Lateral Sclerosis
Official title TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT06726577
What this study is testing
What is TP04HN106?
TP04HN106 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for amyotrophic lateral sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial adopts a multicenter, randomized, double-blind, placebo-controlled parallel design. This experiment is divided into two groups: the experimental drug group and the placebo group.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;
- Age ≥18 years old, male or female;
- The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit people should be ≥1 score for dyspnea, upright breathing and...
- Pre-assigned by chance people received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;
- Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.
You likely can't join if
- The subject is known to be allergic to the investigational drug or its excipients;
- The subject has a disease or injury that interferes with functional assessment or threatens life, or is accompanied by a serious irreversible disease...
- The subject has a major mental illness or cognitive dysfunction;
- Patients with a history of secondary or above surgery within one month before the screening period;
- The people participated in other clinical studies within 1 month;
- The people are pregnant or lactating women;
See the full eligibility criteria
- Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;
- Age ≥18 years old, male or female;
- The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit people should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;
- Pre-assigned by chance people received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;
- Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.
- The subject is known to be allergic to the investigational drug or its excipients;
- 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...
- The subject has a major mental illness or cognitive dysfunction;
- Patients with a history of secondary or above surgery within one month before the screening period;
- The people participated in other clinical studies within 1 month;
- The people are pregnant or lactating women;
- Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion. \-
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.