COMPLEX REGIONAL PAIN SYNDROME - …

COMPLEX REGIONAL PAIN SYNDROME

Informed Consent Overview

About clinical research

Clinical research studies, also called trials, are carried out to learn or add knowledge about the effects and safety of drugs. These drugs are not yet registered or are used to treat other diseases. Trials are subject to strict laws and regulations, international guidelines, and ethical guidelines. This trial, like other trials, has been reviewed by an independent authority and an ethics committee.

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Why is this clinical trial being done?

The purpose of this trial is to evaluate the safety of neridronic acid in patients with complex regional pain syndrome (CRPS). Its effectiveness in reducing pain due to CRPS and its effect on your ability to perform daily activities, quality of life, and other outcomes will also be studied. Another purpose of this trial is to measure levels of markers in your blood that indicate changes in your bones.

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This study and you

Approximately 220 patients globally who have CRPS will be included in this trial. You may qualify for this study if you:

? Are at least 18 years of age ? Have been diagnosed with CRPS ? Have been receiving treatment for

CRPS for at least one month Additional requirements apply. During this trial, the study drug and all study-related care will be provided to you at no cost.

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How long will I be in the study?

You will be in the trial for approximately 14 months. The trial has three periods:

Enrollment period

Up to 60 days before the treatment period begins, the study doctor will ask you about your medical history and perform a series of tests, including a physical exam and taking blood and urine samples, to make sure you qualify.

Treatment period

You will be given the study medication at the study clinic four times over 10 days. The study medication will be given by intravenous (IV) infusion over approximately four hours. Each of these visits may last up to about eight hours.

Follow-up period

Additional medical evaluations will take place to see how you are feeling. You will visit the study clinic six times over approximately 50 weeks. These visits will last about two to three hours. Additional visits may be scheduled if necessary.

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