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

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: K-PAX Pharmaceuticals, Inc.
• Collaborator: VA Palo Alto Health Care System
• Treatments: Methylphenidate

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.

Exclusion Criteria:

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.