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New treatment option for Amyotrophic Lateral Sclerosis
Official title A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT07660614
What this study is testing
What is LTX-002?
LTX-002 is an investigational medicine, given as an injectable medicine, 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 study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Diagnosis of ALS per Gold Coast criteria
- ALS symptom onset less than 36 months prior to Screening
- Slow vital capacity ≥ 50% of predicted value
- Body mass index ≥18 and ≤40 kg/m2
You likely can't join if
- Current evidence or history of a clinically significant medical condition that, in the Investigator's judgement, would impact the participant's...
- History of brain or spinal abnormalities on magnetic imaging (MRI) or computed tomography (CT) that might interfere with the lumbar puncture (LP)...
- Prior treatment with antisense oligonucleotide (ASO), small interfering RNA, stem cell therapy, or gene therapy for any indication
- Tracheostomy
- HIV, Hepatitis B or C infection (acute or chronic)
- Presence of implanted shunt (CSF) or vascular device
See the full eligibility criteria
- Diagnosis of ALS per Gold Coast criteria
- ALS symptom onset less than 36 months prior to Screening
- Slow vital capacity ≥ 50% of predicted value
- Body mass index ≥18 and ≤40 kg/m2
- Current evidence or history of a clinically significant medical condition that, in the Investigator's judgement, would impact the participant's safety, interpretation of study results, or place the participant at high...
- History of brain or spinal abnormalities on magnetic imaging (MRI) or computed tomography (CT) that might interfere with the lumbar puncture (LP), cerebrospinal fluid (CSF) circulation or safety assessments
- Prior treatment with antisense oligonucleotide (ASO), small interfering RNA, stem cell therapy, or gene therapy for any indication
- Tracheostomy
- HIV, Hepatitis B or C infection (acute or chronic)
- Presence of implanted shunt (CSF) or vascular device
- Risk for uncontrolled bleeding
- Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Lübeck, Germany
- Milan, Italy
- Torino, Italy
- Utrecht, Netherlands
- Stockholm, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lübeck, Germany; Milan, Italy; Torino, Italy; Utrecht, Netherlands; Stockholm, Sweden. 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.