What is the MyFi Study?

What is the MyFi Study?

The main purpose of the MyFi clinical research study is to find out if the study drug called milnacipran is safe and effective in helping young people manage their fibromyalgia.

• Researchers want to learn more about fibromyalgia and how it affects adolescents
• Researchers want to learn more about treatment options that may benefit adolescents with fibromyalgia
• About 300 teenagers will participate in this study nationwide
• Milnacipran has been approved by the U.S. Food and Drug Administration (FDA) in adults for the management of fibromyalgia. However, the use of milnacipran in this study is experimental because it has not been approved by the U.S. FDA for use in pediatric (children and adolescents) patients.

How does the study drug work?

The study drug falls into a class of drugs known as serotonin and norepinephrine reuptake inhibitors (SNRIs).

• Serotonin and norepinephrine are substances made by the brain that influence how the brain sends messages to the body and in turn how the body responds to pain
• Researchers think that the study drug may help serotonin and norepinephrine to work better on the central nervous system, which serves as the body’s main message "processing center"

How long will the study last?

The study may last up to 21 weeks and involve 8 or more study visits after the Screening Visit.

• During the Screening Period, which lasts 1–4 weeks, the study doctor will determine if your child is eligible to participate in the MyFi study
• After the Screening Period, all participants will take the study drug for 8 weeks
• If your child tolerates the study drug and qualifies to continue on in the study, he or she will be assigned by chance to a study group either taking the study drug or taking placebo (a tablet that looks like the study drug but has no active medication in it) twice a day, for another 8 weeks

Your child will be closely supervised by the study doctor during his or her participation. The study doctor can tell you more about what will happen at each visit.

What are the risks and benefits?

There is no guarantee that being in the study will help your child. Your child’s fibromyalgia may or may not get better while in this study.

All drugs have some risk of side effects.

• Some adults who have taken milnacipran have experienced nausea, headaches, dizziness, and other symptoms
• All SNRIs carry a risk of increased suicidal tendencies in children

The study doctor can talk to you about all of the side effects people have reported after taking milnacipran.

What is my role as caregiver?

As parent or caregiver, you will participate and oversee all aspects of your child’s involvement in the MyFi study.

• There is no cost to you for the study drug, study visits, or any tests or procedures that are part of the study

Who can participate in the study?

To be eligible to participate in the MyFi study, your child must be 13 to 17 years old and:

• Receive a diagnosis at the first study visit or already have a diagnosis of fibromyalgia
• Have had unsatisfactory results after trying other non-drug treatments for fibromyalgia (e.g., diet, exercise, acupuncture)
• Be willing to take a drug screening test
• Be willing to discontinue certain medications, if required
• If female, be willing to take a pregnancy test

Additional study requirements can be reviewed with site study staff.

Participation in the MyFi study is completely voluntary.

Your child can leave the study at any time and does not have to participate in the study to receive treatment for fibromyalgia.

Before deciding to participate in the MyFi study, you and your child should ask questions and discuss the study with your own doctors, family members, friends, and the clinical research staff.

For more information.

http://www.myfiresearch.com/fibromyalgia.aspx?vendor=nfaemail