Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 24-week, randomized, double-blind, placebo-controlled, trial to evaluate the
      safety, tolerability and efficacy of an orally administered growth hormone stimulating drug,
      (code named MK-0677) in the treatment of female subjects with primary fibromyalgia. The basis
      for this study is the observation that many fibromyalgia patients are growth hormone
      deficient; an earlier study of injectable growth hormone had shown benefit in this population
      of fibromyalgia patients.
    

Detailed description: 
      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).
    

Intervention name(s): Ibutamoren Mesylate (MK-0677)
Intervention type(s): Drug
Intervention description(s): Ibutamoren Mesylate 25 mg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; Treatment; Growth hormone; IGF-1; MK-0677; Oral growth hormone secretagogue