Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

K-PAX Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Methyl-P plus Nutrient Formula
  • Drug: Methyl-P plus Nutrient matched placebos

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - 59 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting