English to Greek Medical Medical: Health Care clinical trial

Baseline Visit:
• This informed consent document and study procedures will be discussed with you and you will be given the opportunity to ask questions. If you decide to permit your child to participate, you will sign and receive a copy of this informed consent document before any study procedures are performed.
• The entry requirements for this study will be reviewed with you.
• Your child will undergo a physical examination including measurements of length, weight, head circumference and arm span.
• Your child’s medical history will be reviewed and current medication use will be recorded.
• X-rays will be taken.
• Your child’s eyes will be examined with an instrument used to look at the back of the eye to detect swelling in the nerve of the eyes.
• Your child will undergo testing of their motor (ability to move) and mental functions by a suitably trained member of the research team.
• Blood samples will be taken after an overnight fast for safety, drug- and bone specific tests. Approximately 1.5 teaspoons of blood will be taken from a vein in your child’s arm. A urine sample will be collected for safety testing.
• Your child will receive an injection under the skin (subcutaneous) of the study drug ENB-0040 at the dose established in the previous study ENB-002-08. The dose to be administered throughout the extension study may be adjusted as appropriate to your child’s care.
• Vital signs (pulse rate, breathing rate, blood pressure and temperature) will be monitored before and every 15 minutes for one hour after ENB-0040 is administered.
• If signs and symptoms of low calcium are seen, testing and treatment will be given.

Your child will also need to return to the clinic 24 hours after the Baseline visit to have a blood sample collected (0.5 teaspoon) for drug specific testing.