The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome
|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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome (CFS) Myalgic Encephalomyelitis (ME)||Drug: Methyl-P plus Nutrient Formula Drug: Methyl-P plus Nutrient matched placebos||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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
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
- Change in patient reported Checklist Individual Strength (CIS) Total Score [ Time Frame: Week 12 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966276
|United States, California|
|Stanford Chronic Fatigue Syndrome/ME Initiative|
|Stanford, California, United States, 94305|
|United States, Florida|
|Nova Southeastern University|
|Fort Lauderdale, Florida, United States, 33328|
|United States, New York|
|Susan Levine, MD|
|New York, New York, United States, 10021|
|United States, Utah|
|Fatigue Consultation Clinic|
|Salt Lake City, Utah, United States, 84102|
|Principal Investigator:||Jose Montoya, M.D.||Stanford University School of Medicine, Division of Infectious Diseases|