View clinical trials related to Acromegaly.
Filter by:The purpose of this study is to assess the safety and efficacy of extended dosing with IONIS GHR-LRx in participants with acromegaly as add-on to somatostatin receptor ligands (SRL) therapy.
Background: For children with gigantism, too much growth hormone (GH) in the body causes abnormal growth and many other problems. Current treatments often don t work; no medical treatment is approved by FDA. Researchers want to see if the drug pegvisomant can help. Objective: To test the role of pegvisomant in children and adolescents with gigantism. Eligibility: People ages 2-18 with GH excess for whom usual treatments have not worked or who are not eliginle for them Design: Participants will be screened with a medical history. The study will last 60 weeks and include at least 3 visits: baseline, 6-month, and 12-month visits. For the baseline visit, participants will stay a few nights for testing. They may stay overnight for the other visits. All visits will include: Medical history Physical exam Questionnaires Heart and liver tests Participants may be photographed in their underwear if they agree. Blood tests: Participants will get a catheter: A small plastic tube will be placed in an arm vein. For some tests, the blood may be drawn every 30 minutes over 3 hours. For other tests, blood will be drawn every 20 minutes over 12 hours. Only clinically necessary tests will be done in each patient. At the baseline visit, participants will have the study drug injected under the skin. They will learn to take the injection at home. They will take the injection daily during the study. The baseline and 12-month visits will include: MRI: Participants will have a dye injected into a vein. They will lie in a machine that takes pictures of the body. Hand X-ray Participants must get their height and weight at their local doctor s office monthly. Participants must have blood and urine tests at their local lab monthly for the first 6 months then every 3 months until the study ends. ...
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral ONO-5788. The study will be conducted in two parts: Part 1 to assess the absolute bioavailability using ONO-5788 and radiolabelled ONO-5788 as intravenous and oral forms; part 2 will assess the mass balance of ONO-5788 using orally administered radiolabelled ONO-5788
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.
An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
Acromegaly is chronic, systemic and highly disabling disease. People with Acromegaly show a significant reduction in peripheral muscle strength associated with a loss resistance and lethargy. They tend the fatigue more easily when compared to individuals without the disease, which involves exercise intolerance and disability resulting in a quality of life impaired. Acromegaly have important functional limitations that adversely affect the performance in the activities of day-to-day and contribute to the worsening of the disease. Based on previous studies, the investigators believe that acromegaly participants with would have benefit from a treatment protocol facing physical performance and improved quality of life. Main Objective: To evaluate the effect of home rehabilitation on quality of life of participants with acromegaly. Methods: In this study of longitudinal intervention, they will undergo a rehabilitation program lasting three months, three times a week lasting 60 minutes each session. The protocol will be the assessment of Acromegaly Quality of Life Questionnaire (AcroQol) questionnaire, functional assessment by the walk test of six minutes (6MWT), peripheral muscle strength and assessment of joint integrity, fatigue will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire that evaluates the fatigue in the chronic participants. The assessment will be in 3 different moment (month 0, month 2 month 3). The treatment protocol will consist of warm-up and cool-down, strengthening exercise and muscular endurance, aerobic training, and balance training and proprioception. Prospects: The participants with acromegaly will benefited significantly after undergoing a physical therapy rehabilitation protocol the following parameters: Resistance and muscle strength, pain conditions and disorders skeletal muscle, improvement in activities of daily living and consequent better quality of life.
Cushing's syndrome (CS) and acromegaly determine myopathy and muscle weakness which persist long-term after control of hormone excess. Fatty infiltration in skeletal muscle (myosteatosis) is associated with muscle atrophy, frailty, and increased morbidity and mortality in several human models. The study is aimed at evaluating muscle structure in patients with controlled CS and acromegaly, and correlate it with functional tests of muscle strength. In addition, circulating molecules potentially mediating persistent myopathy in these patients will also be assessed.
The purpose of the study is to assess the experiences of individuals with acromegaly who are receiving injections as part of their treatment regimen. Another objective of the study is to compare the patients' perception with their doctors' perceptions. The answers are important to help researchers and physicians understand what it is really like to take currently available treatments so that they can make efforts to improve patients' healthcare experiences, reduce treatment burden and, ultimately, improve patient's quality of life.
This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part.