Fibromyalgia
Conditions
Keywords
Fibromyalgia, Fatigue, D-Ribose
Brief summary
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.
Interventions
DRUGD-Ribose Powder
5 g TID for 12 Weeks
DIETARY_SUPPLEMENTPlacebo Powder
5 g TID for 12 Weeks
Sponsors
RiboCor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject's Assessment of Fatigue (NRS) | 12 Weeks |
Secondary
| 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 |
Countries
United States
Outcome results
None listed