The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome
Information source: K-PAX Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME)
Intervention: Methyl-P plus Nutrient Formula (Drug); Methyl-P plus Nutrient matched placebos (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: K-PAX Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Jose Montoya, M.D., Principal Investigator, Affiliation: Stanford University School of Medicine, Division of Infectious Diseases
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).
Clinical Details
Official title: Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Methylphenidate Hydrochloride as a Treatment for Chronic Fatigue Syndrome in Patients Taking a CFS-Specific Nutrient Formula
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change in patient reported Checklist Individual Strength (CIS) Total Score
Secondary outcome: Percentage of patients with 20% or greater improvement in the CIS total scoreConcentration Disturbances Subscore on the CIS Concentration Disturbances Score by Visual Analog Scale (VAS) Fatigue Score by Visual Analog Scale (VAS) Pain Symptoms by Brief Pain Inventory Form Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep) Number of Participants with Adverse Events to Assess Safety and Tolerability
Detailed description:
The Synergy Trial will evaluate the safety and efficacy of a currently available medication
(methylphenidate) combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to
treat Chronic Fatigue Syndrome (CFS).
The CFS Nutrient Formula to be used in this trial is a broad-spectrum micronutrient
supplement that provides CFS patients with vitamins, minerals, and other cofactors (amino
acids, antioxidants, and mitochondrial cofactors) to complement the low-dose Central Nervous
System (CNS) stimulant (methylphenidate). In other words, therapeutic dosages of
micronutrients are provided to support the functioning of the nervous, endocrine, and immune
systems to a level at which a lower than customary dosage of methylphenidate can produce
positive clinical effects on CFS symptoms and also be well tolerated.
Methylphenidate is the generic form of Ritalin®. The dose being tested in this study is
relatively low (5-10mg twice daily). This drug has been in clinical use for over 50 years
for the treatment of Narcolepsy and Attention Deficit Disorder and has a well-described
safety profile when used as recommended. Methylphenidate alone has been studied as a
treatment for CFS in the past and has been shown to produce mild benefits and be
well-tolerated. When provided as innovative therapy, methylphenidate plus this CFS Nutrient
Formula has produced substantial improvements in CFS symptoms in a limited number of
patients, and demonstrated excellent tolerability.
Use of low dose methylphenidate hydrochloride coadministered with a CFS Nutrient Formula has
not been previously evaluated in a controlled clinical study. The risk to patients using
this combination is believed to be low, especially in the context of a well-controlled
clinical study. Furthermore, this combination is not expected to increase the incidence or
severity of adverse events associated with methylphenidate hydrochloride.
Eligibility
Minimum age: 18 Years.
Maximum age: 59 Years.
Gender(s): Both.
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.
Locations and Contacts
Stanford Chronic Fatigue Syndrome/ME Initiative, Stanford, California 94305, United States
Nova Southeastern University, Fort Lauderdale, Florida 33328, United States
Susan Levine, MD, New York, New York 10021, United States
Fatigue Consultation Clinic, Salt Lake City, Utah 84102, United States
Additional Information
http://thesynergytrial.org
Starting date: November 2013
Last updated: September 22, 2014
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