Methylphenidate Plus GWI-Nutrient Formula as a Treatment for Patients With Gulf War Illness
Trial ID or NCT#
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).
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
- 1. Pregnancy or lactation 2. Active substance or alcohol abuse and/or a history of prescription stimulant abuse 3. Hospitalization within the past five years for any of the following: 1. Active substance or alcohol abuse and/or a history of prescription stimulant abuse 2. Major Depressive Disorder (MDD) 3. Post Traumatic Stress Disorder (PTSD) 4. Previous or current diagnosis of schizophrenia or bipolar disorder 5. Currently taking any prescription medication to treat anxiety on a daily basis 6. Use of any of the below medications more than 3 times per week within the past 3 months: 1. MAO inhibitors 2. Anti-psychotic medications 3. Prescription stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, or any other amphetamines) 4. Coumarin anticoagulants (Coumadin®) 7. Daily concurrent use of more than one antidepressant medication except if one of the two antidepressant medications are one of the following (unless specifically granted a waiver by the Medical Monitor): 1. Amitriptyline ≤ 100 qhs 2. Trazodone ≤ 100 qhs 3. Doxepin ≤ 50 qhs 8. Active medical conditions including: 1. Glaucoma 2. Diabetes mellitus 3. Current stomach or duodenal ulcer 4. Uncontrolled hypertension (blood pressure at screening of systolic >160 or diastolic >90) 5. Heart disease (including a history of cardiac arrhythmia, cardiac ischemia, syndrome of Torsade de Pointes, myocardial infarction or cerebrovascular event) 6. Motor tics or a diagnosis or family history of Tourette's syndrome 7. Previous history of seizures 8. A diagnosis of any of the following conditions: - Cancer (receiving systemic treatment either currently or within the past 12 months) - Chronic Renal Disease - Chronic Liver Disease - HIV Infection - Chronic Hepatitis B or C - Systemic Lupus Erythematosus - Multiple Sclerosis - Rheumatoid Arthritis - Parkinson's Disease - Amyotrophic Lateral Sclerosis (ALS) - Any chronic infectious disease lasting six months or longer 9. Clinically significant laboratory test values as determined by the Medical Monitor 10. Clinically significant ECG abnormalities as determined by the Medical Monitor 11. The taking of another investigational treatment either currently or within 30 days of the screening visit 12. Compliance criteria: A subject will not be eligible if he/she, in the opinion of the Investigator, will be unable to comply with any aspect of this study protocol, including the visit schedule.
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