Trial record 5 of 67 for:    "Chronic Fatigue Syndrome"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by K-PAX Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
K-PAX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01966276
First received: October 14, 2013
Last updated: March 12, 2014
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Drug: Methyl-P plus Nutrient Formula
Drug: Methyl-P plus Nutrient matched placebos
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by K-PAX Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in patient reported Checklist Individual Strength (CIS) Total Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with 20% or greater improvement in the CIS total score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Concentration Disturbances Subscore on the CIS [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Concentration Disturbances Score by Visual Analog Scale (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Fatigue Score by Visual Analog Scale (VAS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Pain Symptoms by Brief Pain Inventory Form [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events to Assess Safety and Tolerability [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Placebo Comparator: Methyl-P plus Nutrient matched placebos
Methylphenidate matched placebo + CFS Nutrient Formula matched placebo, both taken twice daily.
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

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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966276

Contacts
Contact: Danya Adolphs 415-381-7504 d.adolphs@kpaxpharm.com
Contact: Anne Lahaderne 415-381-7655 a.lahaderne@kpaxpharm.com

Locations
United States, California
Stanford Chronic Fatigue Syndrome/ME Initiative Recruiting
Stanford, California, United States, 94305
Contact: Ian Valencia         
Principal Investigator: Jose Montoya, M.D.         
United States, Florida
Nova Southeastern University Recruiting
Fort Lauderdale, Florida, United States, 33328
Contact: Irina Rozenfeld, NP    954-262-2860      
Principal Investigator: Nancy Klimas, MD         
United States, New York
Susan Levine, MD Recruiting
New York, New York, United States, 10021
Contact: Susan M Levine, MD         
Principal Investigator: Susan M Levine, MD         
United States, Utah
Fatigue Consultation Clinic Recruiting
Salt Lake City, Utah, United States, 84102
Contact: Ali Allen         
Principal Investigator: Lucinda Bateman, M.D.         
Sponsors and Collaborators
K-PAX Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jose Montoya, M.D. Stanford University School of Medicine, Division of Infectious Diseases
  More Information

Additional Information:
No publications provided

Responsible Party: K-PAX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01966276     History of Changes
Other Study ID Numbers: KPAX-002-01
Study First Received: October 14, 2013
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by K-PAX Pharmaceuticals, Inc.:
Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
central nervous system (CNS)
fatigue
alertness
brain fog
mitochondria
methylphenidate
Ritalin
stimulant
multivitamin
multimineral
micronutrients
supplements

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Encephalomyelitis
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Encephalitis
Brain Diseases
Central Nervous System Infections
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014