Recruitment Advert– acromegaly patients study

Are you currently taking medication to control your acromegaly? Is your condition stable? Then you may be eligible for a new clinical trial.

A new formulation of a marketed (sold) drug for the long term treatment of acromegaly is being developed. This study aims to obtain information on the safety and the tolerability (how well the patient responds to the drug) of this new formulation, when it is given to patients who have controlled acromegaly.

All patients in this study will receivea single injection of a new form of somatostatin drug at a hospital. . The first 24 hours of the treatment follow-up will be performed in the hospital and after these 24 hours, the patient can return home. They will be followed up by a study doctor for 6 months in total, with regular visits to the specialist who will conduct the study.The majority of the visits will be duringthe first 3 months and some of the visits could be performed in the patient’s home to reduce the amount of travel. .

Who can participate in this study?

Patients aged 18 to 75 years, who are male or female of non-child bearing potential (are not able to have children) will be considered for the study, iftheir diseases have been well controlledfor at least 3 months. Patients must have no history of gallstones and meet all other requirements for inclusion. Patients may not receive radiotherapy or planned pituitary surgery during the study. A maximum of 27 patients will be included in the study.

The study will be conducted in Belgium, Czech Republic, France, Germany, Italy, Lithuania, Netherlands, Romania, Russia and the UK.

Do I have to take part?

Your participation in this study is entirely voluntary and you do not have to participate in this study to be treated for your disease. If you decide not to participate in the study, you can still receive standard care/ or explanation of any known alternative therapies that may be available to treat your disease.

What happens after the study?

If you volunteer for the study, once you have completed the visits, you will re-start your original medication.

Do I receive Financial Compensation if I take part?

According to country legislation and approval of the Ethical Committee, financial compensation will be available for your participation to this clinical trial upon completion. In addition, all travel expenses will be reimbursed.

Who is conducting this trial?Ipsen Pharma SAS

Closing date for recruitment: End of July 2016

For further information about this study, please contact:

Study Doctor:Professor Marta Korbonits

Barts Health NHS Trust / Queen Mary, University of London

William Harvey Heart Centre CRC

Charterhouse SquareEC1M 6BQ London

Phone: +44 (0) 20 7882 6238

Phone Research Nurse +44 (0) 20 7882 5657

Professor Peter Trainer

Department of Endocrinology

Christie Hospital

Wilmslow Rd

M20 48X Manchester

Phone: +44 (0) 161 446 3000

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