The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis (ME)

In brief

The Synergy Trial will evaluate the safety and efficacy of a currently available medication (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to treat Chronic Fatigue Syndrome (CFS).

Key facts

Study ID

NCT01966276

Run by

K-PAX Pharmaceuticals, Inc.

People needed

134

Starts

2013-11-01

Expected to finish

2014-12-01

Last updated by the study team

2014-09-25

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must fulfill the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959)
• Subjects must also report alertness and/or concentration deficits
• Otherwise in good health based on medical history and screening evaluation
• Willingness to NOT take any nutritional or herbal supplements other than the study treatment during the course of the trial
• Nutritional supplements that are exempted from this requirement are limited to the following:
• Probiotic supplements
• Fiber supplements
• Fish oil supplements
• Digestive enzymes
• Melatonin ≤ 10mg per day
• Calcium ≤ 600 mg per day
• Magnesium ≤ 400 mg per day
• Vitamin D ≤ 400 i.u. per day
• Willingness to NOT consume any caffeine-containing supplements during the study period (coffee, tea, or chocolate are exempt). These include but are not limited to the following beverages:
• Red Bull®
• Monster®
• Rockstar®
• 5-hour® energy shots
• Willingness to NOT consume any pseudoephedrine-containing products during the study period
• Willingness to practice effective contraception

You may not qualify if…

• Pregnancy or lactation
• Active substance abuse
• Major depression as defined by Zung Depression Scale score ≥ 60
• Use of rintatolimod (Ampligen®) within the past 3 months
• Currently taking any prescription medication to treat anxiety on a daily basis
• Use of more than 3 times/week within the past 3 months of:
• Monoamine oxidase inhibitors (MAOs)
• Anti-psychotic medications
• CNS stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, amphetamines)
• Narcotic opioids
• Tramadol (i.e. Ultram®, Ultracet®, Conzip®, or Ryzolt®)
• Gabapentin (Neurontin®) > 600mg/day
• Pregabalin (Lyrica®)
• Duloxetine (Cymbalta®)
• Milnacipran (Savella®)
• Coumarin anticoagulants (Coumadin®)
• Valganciclovir (Valcyte®)
• Daily concurrent use of more than one antidepressant medication except if one of the two antidepressant medications are:
• Amitriptyline ≤ 30mg at bedtime
• Trazodone ≤ 50mg at bedtime
• Doxepin ≤ 20mg at bedtime
• Active medical conditions to which treatment with methylphenidate hydrochloride or micronutrients may be contraindicated, including:
• Glaucoma
• Diabetes Mellitus
• Current stomach or duodenal ulcer

Where it is running

• Stanford Chronic Fatigue Syndrome/ME Initiative — Stanford, California, United States
• Nova Southeastern University — Fort Lauderdale, Florida, United States
• Susan Levine, MD — New York, New York, United States
• Fatigue Consultation Clinic — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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