The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|