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

NCT02357030 | Unknown Phase 2

• 2 other identifiers: K-PAX-002-2CDMRP- GW130047
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Gulf War Illness

Keywords

Gulf War Illness; nutrients; methylphenidate; mitochondria

Outcome Measures

Primary Outcomes (1)

• Change in patient reported Checklist Individual Strength (CIS) total score

  Week 12

Secondary Outcomes (9)

• Percentage of patients with 20% or greater improvement in the CIS total score

  Week 12

• 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

Study Arms (1)

Methyl-P plus GWI Nutrient Formula

EXPERIMENTAL

Methylphenidate hydrochloride plus a GWI Nutrient Formula (K-PAX Synergy), both taken twice daily.

Drug: Methyl-P plus GWI Nutrient Formula

Interventions

Methyl-P plus GWI Nutrient Formula DRUG

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

Also known as: KPAX 002

Methyl-P plus GWI Nutrient Formula

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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):
• Probiotic supplements (L. acidophilus, Bifidobacterium, etc.)
• Fiber supplements
• Fish oil supplements
• Digestive enzymes
• Melatonin \< 10mg per day
• Calcium \< 600mg per day
• Magnesium \< 400mg per day
• Vitamin D \< 400 i.u. per day
• 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:
• Red Bull®
• Monster®
• Rockstar®
• hour® energy shots
• Willingness to not consume any prescription stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, amphetamines) during the study period.

Sponsors & Collaborators

• K-PAX Pharmaceuticals, Inc.: lead
• VA Palo Alto Health Care System: collaborator

Study Sites (1)

Veterans Administration Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, 94304, United States

RECRUITING

Study Officials

• Jon D. Kaiser, MD

  K-PAX Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Mark Holodniy, MD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Lopez

CONTACT

(650) 493-5000; jessica.lopez@va.gov

Danya Adolphs

CONTACT

(415) 381-7599; d.adolphs@kpaxpharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

US (1)