D-Ribose for Fatigue in Subjects With Fibromyalgia

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: D-Ribose Powder
* Dietary Supplement: Placebo Powder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-Ribose<br> | Drug: D-Ribose Powder<br>* 5 g TID for 12 Weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo Powder<br>* 5 g TID for 12 Weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Fatigue, D-Ribose