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

PHASE2UnknownINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

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"

Trial Locations (4)

10021

Susan Levine, MD, New York

33328

Nova Southeastern University, Fort Lauderdale

84102

Fatigue Consultation Clinic, Salt Lake City

94305

Stanford Chronic Fatigue Syndrome/ME Initiative, Stanford

Sponsors
All Listed Sponsors
lead

K-PAX Pharmaceuticals, Inc.

INDUSTRY