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

NCT02357030 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-10-15

No results posted yet for this study

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).

Conditions

  • Gulf War Illness

Interventions

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

Sponsors & Collaborators

  • VA Palo Alto Health Care System

    collaborator FED

  • K-PAX Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jon D. Kaiser, MD · K-PAX Pharmaceuticals, Inc.

  • Mark Holodniy, MD · VA Palo Alto Health Care System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02357030 on ClinicalTrials.gov