Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia

This study examines whether MK-0677 treatment will improve symptoms of fibromyalgia (FM). The rationale for this study is the observation that many fibromyalgia patients are growth hormone deficient in terms of low levels of IGF-1, and that improving IGF-1 levels with growth hormone injections has been shown to improve fibromyalgia symptoms. MK-0677 is an orally administered growth hormone secretagogue manufactured by Merck \& Co., Inc. that acts on the growth hormone secretagogue receptor in the anterior pituitary to stimulate the release of growth hormone. This pathway represents an additional regulation of growth hormone release from pituitary somatotrophs to that mediated by growth hormone releasing hormone (stimulating) and somatostatin (inhibitory). Both stimulatory pathways lead to a pulsatile release of growth hormone, with approximately 4 hour intervals between peak levels. This growth hormone secretion leads to a rapid and robust up regulation of IGF-1 levels by about 50 to 100% that can be maintained with chronic therapy at a dose of 25 mg/day. The primary aims of this study are: 1. To evaluate the efficacy of MK-0677 25 mg in primary fibromyalgia subjects over a 24-week treatment period, as assessed by the FIQ. 2. To evaluate the safety and tolerability of MK-0677 25 mg in subjects with fibromyalgia. The secondary aims of this study are to determine whether: 1. MK-0677 25 mg is superior to placebo in reducing muscle tenderness, as assessed by the Fibromyalgia Myalgic Score (FMyS). 2. MK-0677 25 mg is superior to placebo in improving the subjects' global perception of change in fibromyalgia symptoms, as assessed by the Subjects' Global Impression of Change Questionnaire (PGIC). 3. MK-0677 25 mg is superior to placebo in improving the subjects' quality of life, as assessed by the Quality of Life Questionnaire (QOL).