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

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What is this study about?

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej Bialystok Poland
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Wroclaw Medical University Wroclaw Poland
Sonomed Sp. z o.o. Szczecin Poland
Ujucslsblxpdul Cfvyuqy Krsvdqpej Gdansk Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Recruiting
01.08.2023

Trial locations

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.

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.

Trial ID:
2023-504020-25-00
Protocol code:
LUM-201-02
NCT ID:
NCT05796440
Trial Phase:
Therapeutic exploratory (Phase II)

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