NCT01966276

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: K-PAX Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-10-21
• Last updated: 2014-09-25

Locations

4 sites across 1 country: United States