D-Ribose for Fatigue in Subjects With Fibromyalgia

RiboCor

Status and phase

Completed

Phase 2

Conditions

Fibromyalgia

Treatments

Dietary Supplement: Placebo Powder

Drug: D-Ribose Powder

Study type

Interventional

Funder types

Industry

Identifiers

NCT01315210

BIOE 02C 010

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.