What is the purpose of the Synergy Trial?

The purpose of the Synergy Trial is to learn about the safety and efficacy of a possible new treatment for Chronic Fatigue Syndrome (CFS), also referred to as Myalgic Encephalomyelitis (ME), using a combination of low-dose methylphenidate (generic Ritalin®) co-administered with a CFS-specific nutritional supplement.

How long will the trial last?

After the screening visit, if you meet all of the study criteria, you will be provided either the active treatment or placebo for a total of 12 weeks. There will be 3 in-person visits required during the 12-week study period.

Will I receive compensation for participating?

After screening, should you be accepted to participate in the study, you will receive a $50 stipend for each in-person site visit (total $150) to help cover the costs to participate. In addition, if you complete the full 12-week study, a 3-month supply of the actual CFS Nutrient Formula used in the trial will be provided at no cost.

Am I allowed to quit the trial before completion?

Yes, you are allowed to discontinue participating in this trial at any time.

Is there any continued treatment available once the trial is completed?

If you complete the entire 12 weeks of the trial, you will be provided with a 3-month supply of the CFS Nutrient Formula at no cost. Methylphenidate, the drug that is being tested in this trial, is currently available by prescription and can be prescribed in conjunction with the CFS Nutrient Supplement by your physician.

Is this a FDA approved clinical trial?

Yes.

Where are the clinical test sites located?

There are four study sites planned:

• Palo Alto, California (Stanford University)
• Manhattan, NY
• Salt Lake City, UT
• Fort Lauderdale, FL

What does double-blinded, placebo-controlled trial mean?

In a double-blinded, placebo-controlled trial, neither the test participants nor the researchers know who is getting the treatment and who is getting the placebo (an inactive substance). This helps prevent the results from being affected by the participant’s beliefs or the researcher’s opinions.

Are there any risks or side effects associated with the treatment?

Possible side effects from this treatment are those that can be experienced with the use of stimulant medications. These include dry mouth, abdominal pain, nausea, vomiting, diarrhea, constipation, anxiety, drowsiness, insomnia, hypersensitivity, anorexia, weight loss, dizziness, palpitations, headaches, or involuntary movements. Rare risks are blood pressure or heart rate changes, chest pain, or a constant urge to be moving. In addition, there may be unknown or unforeseeable risks associated with the use of the study drug, including allergic reaction or interaction with another medication.

How will my condition and the effectiveness of the treatment be monitored?

Test participants will be closely monitored by the medical research staff at the assigned test site throughout the course of the trial. There will be 7 visits (4 on-site and 3 by phone) starting from the initial assessment and concluding with the final on-site visit.

Will results of the trials be provided to me?

Once the study is completed (i.e. all 120 patients finish the 12-week treatment period), the data will be analyzed and reported in the scientific literature. An overview of the study’s findings will be posted online and available to all who want to review it.

How will the medical researchers protect my confidentiality?

The Synergy Trial has been evaluated and approved by the US Food and Drug Administration (FDA) and will be conducted in a manner that meets all guidelines as set forth by the FDA to protect the safety and privacy of participants. The Synergy Trial will also be monitored by an Institutional Review Board (IRB) to ensure that the trial is safe, ethical and that the rights of the participants are properly protected. Your identity will be kept as confidential as possible as required by law.

Will I be allowed to continue seeing my regular doctors during the course of the study?

Yes, however, there are certain medications that you will be prohibited from taking during the course of this study (see Am I Eligible?).

How will the results of the Synergy trial affect the care doctors provide CFS patients?

By participating in the Synergy Trial you will be assisting the medical community to find answers about how to more effectively treat CFS. It is with the help of research study participants like yourself that doctors will be better able to treat CFS in the future.

Who is sponsoring the Synergy Trial?

The study sponsor is K-PAX Pharmaceuticals, an integrative medicine pharmaceutical company currently pioneering medicines to strengthen immune function and support optimal energy metabolism.

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If you would like to participate in the Synergy Trial, please call 1-855-318-HOPE (4673) to speak to a Synergy Trial representative and continue the screening process.