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The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome

NCT01966276 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2014-09-25

No results posted yet for this 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).

Conditions

  • Chronic Fatigue Syndrome (CFS)
  • Myalgic Encephalomyelitis (ME)

Interventions

DRUG

Methyl-P plus Nutrient Formula

* Week 1 (take the following together twice a day-at breakfast and lunch) * One tablet of Methyl-P (5mg) * Four tablets of CFS Nutrient Formula * Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch): * Two tablets of Methyl-P (10mg) * Four tablets of CFS Nutrient Formula

DRUG

Methyl-P plus Nutrient matched placebos

* Week 1 (take the following together twice a day-at breakfast and lunch) * One tablet of Methyl-P Placebo * Four tablets of CFS Nutrient Placebo * Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch): * Two tablets of Methyl-P Placebo * Four tablets of CFS Nutrient Placebo

Sponsors & Collaborators

  • K-PAX Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jose Montoya, M.D. · Stanford University School of Medicine, Division of Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01966276 on ClinicalTrials.gov