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

NCT01966276 | Unknown Phase 2

• 1 other identifier: KPAX-002-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 4

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).

Conditions

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

Keywords

Chronic Fatigue Syndrome (CFS); Myalgic Encephalomyelitis (ME); central nervous system (CNS); fatigue; alertness; brain fog; mitochondria; methylphenidate; Ritalin; stimulant; multivitamin; multimineral; micronutrients; supplements

Outcome Measures

Primary Outcomes (1)

• Change in patient reported Checklist Individual Strength (CIS) Total Score

  Week 12

Secondary Outcomes (7)

• Percentage of patients with 20% or greater improvement in the CIS total score

  Week 12

• Concentration Disturbances Subscore on the CIS

  Week 12

• Concentration Disturbances Score by Visual Analog Scale (VAS)

  Week 12

• Fatigue Score by Visual Analog Scale (VAS)

  Week 12

• Pain Symptoms by Brief Pain Inventory Form

  Week 12

Study Arms (2)

Methyl-P plus Nutrient Formula

EXPERIMENTAL

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

Methyl-P plus Nutrient matched placebos

PLACEBO COMPARATOR

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

Drug: Methyl-P plus Nutrient matched placebos

Interventions

Methyl-P plus Nutrient Formula 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

Also known as: Ritalin

Methyl-P plus Nutrient Formula

Methyl-P plus Nutrient matched placebos 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

Methyl-P plus Nutrient matched placebos

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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®

You may not qualify if:

• 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®)

Sponsors & Collaborators

• K-PAX Pharmaceuticals, Inc.: lead

Study Sites (4)

Stanford Chronic Fatigue Syndrome/ME Initiative

Stanford, California, 94305, United States

Location

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

Susan Levine, MD

New York, New York, 10021, United States

Location

Fatigue Consultation Clinic

Salt Lake City, Utah, 84102, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue; Mental Fatigue

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jose Montoya, M.D.

  Stanford University School of Medicine, Division of Infectious Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 21, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

US (4)