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

Chronic Fatigue Syndrome (CFS) Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01966276
• Other study ID #: KPAX-002-01
• Status: Unknown status
• Phase: Phase 2
• First received: October 14, 2013
• Last updated: September 22, 2014
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: K-PAX Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 134
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome (CFS)
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis (ME)
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
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	Stanford Chronic Fatigue Syndrome/ME Initiative	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
K-PAX Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient reported Checklist Individual Strength (CIS) Total Score		Week 12
Secondary	Percentage of patients with 20% or greater improvement in the CIS total score		Week 12
Secondary	Concentration Disturbances Subscore on the CIS		Week 12
Secondary	Concentration Disturbances Score by Visual Analog Scale (VAS)		Week 12
Secondary	Fatigue Score by Visual Analog Scale (VAS)		Week 12
Secondary	Pain Symptoms by Brief Pain Inventory Form		Week 12
Secondary	Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep)		Week 12
Secondary	Number of Participants with Adverse Events to Assess Safety and Tolerability		Week 12

External Links

•   http://thesynergytrial.org