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Methyl-P plus Nutrient Formula for Chronic Fatigue Syndrome

Phase 2
Waitlist Available
Led By Jose Montoya, M.D.
Research Sponsored by K-PAX Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

The Synergy Trial will evaluate the safety and efficacy of a currently available medication (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to treat Chronic Fatigue Syndrome (CFS).

Eligible Conditions
  • Chronic Fatigue Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in patient reported Checklist Individual Strength (CIS) Total Score
Secondary outcome measures
Concentration Disturbances Score by Visual Analog Scale (VAS)
Concentration Disturbances Subscore on the CIS
Fatigue Score by Visual Analog Scale (VAS)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Methyl-P plus Nutrient FormulaExperimental Treatment1 Intervention
Methylphenidate hydrochloride plus a CFS Nutrient Formula, both taken twice daily. The CFS Nutrient Formula is a broad-spectrum CFS-specific dietary supplement that provides CFS patients with cellular fuel and cofactors (amino acids, antioxidants, and mitochondrial cofactors) while the low-dose CNS stimulant (methylphenidate hydrochloride) provides a metabolic catalyst to enhance cellular metabolism.
Group II: Methyl-P plus Nutrient matched placebosPlacebo Group1 Intervention
Methylphenidate matched placebo + CFS Nutrient Formula matched placebo, both taken twice daily.

Find a Location

Who is running the clinical trial?

K-PAX Pharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Jose Montoya, M.D.Principal InvestigatorStanford University School of Medicine, Division of Infectious Diseases

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
Delaware
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Susan Levine, MD
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome
2013. "The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01966276.
All > Me Cfs > Chronic Fatigue Syndrome
~12 spots leftby May 2025
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