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

NCT ID: NCT01966276

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-12-31

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.

Conditions

Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Methyl-P plus Nutrient Formula

Intervention Type: DRUG

• 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

Methyl-P plus Nutrient matched placebos

Methylphenidate matched placebo + CFS Nutrient Formula matched placebo, both taken twice daily.

Group Type: PLACEBO_COMPARATOR

Methyl-P plus Nutrient matched placebos

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Ritalin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

K-PAX Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Montoya, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University School of Medicine, Division of Infectious Diseases

Locations

Stanford Chronic Fatigue Syndrome/ME Initiative

Stanford, California, United States

Nova Southeastern University

Fort Lauderdale, Florida, United States

Susan Levine, MD

New York, New York, United States

Fatigue Consultation Clinic

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

KPAX-002-01

Identifier Type: -

Identifier Source: org_study_id