Gulf War Illness
Conditions
Keywords
Gulf War Illness, nutrients, methylphenidate, mitochondria
Brief 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.
Interventions
DRUGMethyl-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
Sponsors
VA Palo Alto Health Care System
K-PAX Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female patients between the ages of 18 and 64, inclusive at the time of informed consent 2. Patients who currently meet the Kansas Case Definition for GWI 3. Patients who are otherwise in good health based on medical history and screening evaluation as determined by Investigator (see below for specific
Exclusion criteria
) 4. Willingness to not take any multivitamin, nutritional or herbal supplements other than the study treatment during the course of the trial; at least a one week washout of current nutritional supplements will be required between the screening and baseline visits. Nutritional supplements that are exempted from this requirement are limited to the following (other exemptions require a waiver by the Medical Monitor): 1. Probiotic supplements (L. acidophilus, Bifidobacterium, etc.) 2. Fiber supplements 3. Fish oil supplements 4. Digestive enzymes 5. Melatonin \< 10mg per day 6. Calcium \< 600mg per day 7. Magnesium \< 400mg per day 8. Vitamin D \< 400 i.u. per day 5. Willingness to not consume any caffeine-containing supplements during the study period (coffee, tea and chocolate are exempt). These supplements include but are not limited to the following: 1. Red Bull® 2. Monster® 3. Rockstar® 4. 5-hour® energy shots 6. Willingness to not consume any prescription stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, amphetamines) during the study period. 7. Willingness to not consume any pseudoephedrine-containing products during the study period. 8. Willingness of females to practice effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in patient reported Checklist Individual Strength (CIS) total score | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Concentration Disturbances Subscore on the CIS | Week 12 |
| Concentration Disturbances Score by Visual Analog Scale (VAS) | Week 12 |
| Fatigue Score by Visual Analog Scale (VAS) | Week 12 |
| Pain Score by Visual Analog Scale (VAS) | Week 12 |
| Percentage of patients with 20% or greater improvement in the CIS total score | Week 12 |
| Mitochondrial Function Assays | Week 12 |
| GWI Symptoms Assessment Tool (SAT) Score | Week 12 |
| Number of Participants with Adverse Events to Assess Safety and Tolerability | Week 12 |
| Sleep Score by Visual Analog Scale (VAS) | Week 12 |
Countries
United States
Contacts
Primary ContactJessica Lopez
Backup ContactDanya Adolphs
Outcome results
None listed