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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01966276
Recruitment Status : Unknown
Verified September 2014 by K-PAX Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
K-PAX Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE October 21, 2013
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
Change in patient reported Checklist Individual Strength (CIS) Total Score [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2013)
  • Percentage of patients with 20% or greater improvement in the CIS total score [ Time Frame: Week 12 ]
  • Concentration Disturbances Subscore on the CIS [ Time Frame: Week 12 ]
  • Concentration Disturbances Score by Visual Analog Scale (VAS) [ Time Frame: Week 12 ]
  • Fatigue Score by Visual Analog Scale (VAS) [ Time Frame: Week 12 ]
  • Pain Symptoms by Brief Pain Inventory Form [ Time Frame: Week 12 ]
  • Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep) [ Time Frame: Week 12 ]
  • Number of Participants with Adverse Events to Assess Safety and Tolerability [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome
Official Title  ICMJE 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
Brief 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Fatigue Syndrome (CFS)
  • Myalgic Encephalomyelitis (ME)
Intervention  ICMJE
  • Drug: Methyl-P plus Nutrient Formula
    • Week 1 (take the following together twice a day-at breakfast and lunch)

      • One tablet of Methyl-P (5mg)
      • Four tablets of CFS Nutrient Formula
    • Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch):

      • Two tablets of Methyl-P (10mg)
      • Four tablets of CFS Nutrient Formula
    Other Name: Ritalin
  • Drug: Methyl-P plus Nutrient matched placebos
    • Week 1 (take the following together twice a day-at breakfast and lunch)

      • One tablet of Methyl-P Placebo
      • Four tablets of CFS Nutrient Placebo
    • Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch):

      • Two tablets of Methyl-P Placebo
      • Four tablets of CFS Nutrient Placebo
Study Arms  ICMJE
  • Experimental: Methyl-P plus Nutrient Formula

    Methylphenidate hydrochloride plus a CFS Nutrient Formula, both taken twice daily.

    The CFS Nutrient Formula is a broad-spectrum CFS-specific dietary supplement that provides CFS patients with cellular fuel and cofactors (amino acids, antioxidants, and mitochondrial cofactors) while the low-dose CNS stimulant (methylphenidate hydrochloride) provides a metabolic catalyst to enhance cellular metabolism.

    Intervention: Drug: Methyl-P plus Nutrient Formula
  • Placebo Comparator: Methyl-P plus Nutrient matched placebos
    Methylphenidate matched placebo + CFS Nutrient Formula matched placebo, both taken twice daily.
    Intervention: Drug: Methyl-P plus Nutrient matched placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: September 22, 2014)
134
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2013)
120
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01966276
Other Study ID Numbers  ICMJE KPAX-002-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party K-PAX Pharmaceuticals, Inc.
Study Sponsor  ICMJE K-PAX Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose Montoya, M.D. Stanford University School of Medicine, Division of Infectious Diseases
PRS Account K-PAX Pharmaceuticals, Inc.
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP