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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: K-PAX Pharmaceuticals, Inc.
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Uncontrolled hypertension (blood pressure at screening of systolic >150 or diastolic >90)

• Heart disease (including cardiac arrhythmia, cardiac ischemia, syndrome of Gilles de la Tourette or a past history of myocardial infarction or cerebrovascular event)

• Motor tics or family history of psychosis or bipolar disorder

• Previous history or seizures

• A diagnosis of other conditions that may be in part responsible for the patient's fatigue including, but not limited to:

• HIV infection

• Chronic Hepatitis B & C

• Cancer (receiving treatment either currently or within the past two years)

• Chronic Renal Disease

• Clinically significant laboratory test values as determined by the Investigator

• Clinically significant ECG abnormalities as determined by the Medical Monitor

• Compliance criteria: A subject will not be eligible if he/she, in the opinion of the Investigator, will be unable to comply with any aspect of this study protocol, including the visit schedule.