D-Ribose for Fatigue in Subjects With Fibromyalgia

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of D-Ribose in Subjects With Fibromyalgia

To evaluate the safety and to determine the efficacy of D-ribose for the amelioration of fatigue in subjects with fibromyalgia. This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center, multiple dose study of D-ribose versus placebo administered at doses of 5 g three times a day (TID) over a 12-week period to subjects who are experiencing fatigue associated with a diagnosis of fibromyalgia.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: D-Ribose Powder; Dietary supplement: Placebo Powder

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95825
      • Superior Research, LLC
  • Florida
    • Deland, Florida, United States, 32720
      • Avail Clinical Research
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Columbia Medical Practice
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Major Inclusion Criteria:

• must have a diagnosis of primary fibromyalgia, as defined by the 1990 American College of Rheumatology (ACR) Criteria for the Classification of Fibromyalgia made at least 6 weeks prior to the Pretreatment Screening Visit;
• must have a score of ≥5 on the Subject's Assessment of Fatigue 11-point numerical rating scale (NRS) at the Pretreatment Screening and Baseline Visits;
• if taking acetaminophen or other non-opioid analgesics, NSAIDs, fibromyalgia medications, medications to induce sleep, or prednisone ≤ 10 mg (or equivalent dose of other glucocorticoids), must be on stable dose(s) for at least 4 weeks prior to the baseline visit;
• must have discontinued any ribose-containing products (including foods, drinks, and supplements) at least 4 weeks prior to the Pretreatment Baseline Visit.

Major Exclusion Criteria:

• current major depressive episode (MDE);
• has been diagnosed with any autoimmune disease;
• has been diagnosed with type I or type II diabetes;
• has a history of cancer, other than basal cell carcinoma, stage 1 squamous cell carcinoma or cervical carcinoma in situ, that has not been in remission for at least five years prior to the Pretreatment Screening Visit;
• has been diagnosed with chronic fatigue syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo Powder; 5 g TID for 12 Weeks
Experimental: D-Ribose	Drug: D-Ribose Powder; 5 g TID for 12 Weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subject's Assessment of Fatigue (NRS)	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Revised Fibromyalgia Impact Questionnaire	12 Weeks
Multidimensional Fatigue Inventory	12 Weeks
Subject's Global Impression of Change	12 Weeks
SF-36	12 Weeks
Subject's Assessment of Pain Intensity (NRS)	12 Weeks

Collaborators and Investigators

• Sponsor: RiboCor, Inc.
• Investigators: Principal Investigator: Leslie Crofford, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 13, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Fatigue; Fibromyalgia; D-Ribose
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: BIOE 02C 010