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

What Was Tested

The trial (phase 2) is built around MK-677 (Ibutamoren).

It had 1 arm (groups): Placebo (placebo comparator).

Placebo.

The registry classes the interventions as drug.

More on the Plan

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.

The primary aims of this study are: 1.

The secondary aims of this study are to determine whether: 1.

Who Took Part

64 actual participants took part.

It was open to women only aged from 30 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects will all be female primary fibromyalgia subjects who are 30 to 65 years of age, inclusive, and have a low age adjusted serum IGF-1 level. All subjects will fulfill a diagnosis of fibromyalgia according to the classification criteria of the American College of Rheumatology (ACR). All subjects will have an initial Fibromyalgia Impact Questionnaire (FIQ) score ≥ 40. Subject is not pregnant and is not nursing. Subject is willing to discontinue using grapefruit juice for duration of study.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: subject has an-ongoing, unresolved disability litigation; subject has a history of angina or congestive heart failure with symptoms that occur at rest; subject has history of neurological disorder other than fibromyalgia (e.g. epilepsy, stroke, neuropathy, neuropathic pain).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the MK-677 (Ibutamoren) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received MK-677 (Ibutamoren).

Those kept unaware of assignments: participant and investigator.

It started in 2005-07 with completion listed for 2008-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of MK-677 (Ibutamoren) in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MK-677 (Ibutamoren) compound page, all human trials.