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
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).
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.
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