RecruitingRare disease

Long-Term Safety Study of LUM-201 (Ibutamoren Mesilate) in Children with Growth Hormone Deficiency

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on children with Idiopathic Growth Hormone Deficiency, a condition where the body does not produce enough growth hormone, leading to slower growth in children. The study is examining the long-term safety of a treatment called LUM-201, which contains the active substance Ibutamoren Mesilate. This medication is taken in the form of a tablet.

The purpose of the study is to monitor the safety of LUM-201 over an extended period. Participants in the study will continue their treatment and be regularly monitored by healthcare professionals. The study will track various health indicators, such as growth hormone levels and changes in height and weight, every six months. Additionally, the study will assess changes in bone age compared to chronological age annually.

Throughout the study, participants will have regular check-ups to ensure their well-being and to observe any side effects or changes in their health. The study aims to provide valuable information on the long-term use of LUM-201 in managing Idiopathic Growth Hormone Deficiency in children.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after successful completion of a previous study involving LUM-201 for at least 12 months.
Eligibility is confirmed by the principal investigator, and informed consent must be signed by a parent or caregiver, with assent from the participant if applicable.
Step 2
Medication administration
The medication used in this study is LUM-201, which is taken orally in the form of a tablet.
The specific dosage and frequency will be determined by the study protocol and the healthcare provider overseeing the trial.
Step 3
Monitoring and assessments
Regular monitoring includes checking for any adverse events (AEs) or serious adverse events (SAEs), as well as laboratory tests and physical examinations.
Every 6 months, assessments will be conducted to measure growth hormone (GH) levels, insulin-like growth factor 1 (IGF-1) levels, and insulin-like growth factor-binding protein 3 (IGFBP-3) levels.
Changes in height, weight, body mass index (BMI), and bone age compared to chronological age will also be evaluated.
Step 4
Long-term follow-up
The study aims to monitor the long-term safety of LUM-201 treatment in children with idiopathic growth hormone deficiency.
The estimated end date for the study is November 30, 2028.

Who can join the trial?

4 criteria

The child's parent or caregiver must sign a form agreeing to participate, and the child must also agree if they are old enough.
The child must have already taken part in a previous study with the medicine LUM-201 for at least 12 months and be eligible to continue treatment. This means they must have shown a growth rate of at least 6.7 centimeters per year after 12 months of treatment in the LUM-201-01 trial, or 80% of the first year's growth with another treatment called rhGH in the LUM-201-04 trial.
If the child is sexually active, they must use a reliable method to prevent pregnancy.
The child must be approved for a Day 1 visit by the main doctor in charge of the study.

Who cannot join the trial?

6 criteria

Children who do not have idiopathic growth hormone deficiency cannot participate. This means the child must have a specific type of growth hormone deficiency where the cause is unknown.
Children who are not within the age range specified for the study cannot participate. The study is for a specific age group.
Children who have other medical conditions that might interfere with the study cannot participate. This ensures the study results are accurate and safe for participants.
Children who are taking medications that might affect growth hormone levels cannot participate. This is to make sure the study results are not influenced by other treatments.
Children who have had previous treatments for growth hormone deficiency that might affect the study cannot participate. This is to ensure the study results are not affected by past treatments.
Children who are not able to follow the study procedures or attend all required visits cannot participate. This is important for the safety and accuracy of the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Instytut Pomnik Centrum Zdrowia Dziecka
Verified
Warsaw, Poland
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej
Verified
Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
Verified
Gdansk, Poland

Trial locations

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Investigated drugs

LUM-201 is a medication being studied for its potential to help children with idiopathic growth hormone deficiency. This condition means that the child's body does not produce enough growth hormone, which is important for normal growth and development. The trial aims to monitor the long-term safety of using LUM-201 in these children to ensure it is safe for extended use.

Ibutamoren Mesilate

What is already known about the treatment

LUM-201 – LUM-201 is administered orally and is currently being studied in clinical trials to evaluate its long-term safety in children with idiopathic growth hormone deficiency. This medication is still under investigation and not yet widely used in standard medical practice. It is primarily indicated for treating growth hormone deficiency, a condition where the body does not produce enough growth hormone. LUM-201 works by stimulating the pituitary gland to release more growth hormone, helping to promote growth in children. It is classified as a growth hormone secretagogue, which means it encourages the secretion of growth hormone.

Investigated diseases

Idiopathic Growth Hormone Deficiency – This condition occurs when the pituitary gland does not produce enough growth hormone, which is essential for normal growth in children. The cause of this deficiency is unknown, hence the term "idiopathic." Children with this condition may experience slower growth rates compared to their peers, resulting in shorter stature. Over time, they may also have delayed bone age, meaning their bones mature more slowly than expected for their chronological age. This can lead to a discrepancy between their physical appearance and their actual age. Additionally, children might have increased body fat and reduced muscle mass due to the lack of growth hormone.