NCT02357030

Methylphenidate Plus GWI-Nutrient Formula as a Treatment for Patients With Gulf War Illness

Phase IIa Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of KPAX 002 (Methylphenidate Hydrochloride + K-PAX Synergy) as a Treatment for Gulf War Illness in Patients Meeting the Kansas Case Definition

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: K-PAX Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy) to treat Gulf War Illness (GWI).

Detailed description

This trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a mitochondrial support nutrient formula (K-PAX Synergy) to treat Gulf War Illness (GWI). The nutrient formula to be used in this trial is a broad-spectrum micronutrient supplement. This nutrient formula provides GWI patients with vitamins, minerals, and other cofactors (amino acids, antioxidants, and mitochondrial cofactors) to complement the low-dose Central Nervous System (CNS) stimulant (methylphenidate). The low-dose CNS stimulant provides the necessary catalyst to augment the metabolism of cellular fuel and the production of cellular energy.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 GWI symptoms and also be well tolerated without further depleting or degrading these systems. The dose of methylphenidate (Ritalin®) 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. GWI and Chronic Fatigue Syndrome (CFS) share a high degree of symptom overlap. They have both been linked to mitochondrial dysfunction. 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 coadministered with a mitochondria support 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.

Conditions

• Gulf War Illness

Interventions

Type	Name	Description
DRUG	Methyl-P plus GWI Nutrient Formula	Week 1: * One tablet of Methyl-P (5mg) twice daily * Four tablets of GWI Nutrient Formula twice daily Week 2 to Week 12 : * Two tablets of Methyl-P (10mg) twice daily * Four tablets of GWI Nutrient Formula twice daily

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-02-06
• Last updated: 2015-10-15

Locations

1 site across 1 country: United States