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Completed

NCT Number: NCT00535587

Testing Mestinon and Exercise in Fibromyalgia

The purpose of this trial was to test the combined and independent effects of 6 months of exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms improved by the end of the trial.

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Key information

Conditions

Fibromyalgia Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97219, United States

About this study

Earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone when they exercise intensively. We also demonstrated that a single dose of Mestinon helped people make normal levels of growth hormone when they exercised in our laboratory. We wanted to know if 6 months of exercise with concurrent Mestinon therapy would make growth hormone (and related markers) normal and improve fibromyalgia symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have Fibromyalgia

Exclusion criteria

  • Subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.

Treatment and study plan

Exercise

Behavioral

Pyridostigmine

Drug

Other names: Mestinon

Placibo

Drug

Attention Control

Behavioral

Primary outcomes

  1. Levels of Growth Hormone Post Exercise

    Time frame: 6 months

    Serum growth hormone at peak V02/treadmill

Secondary outcomes

  1. Improvement of Fibromyalgia Symptoms

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Maximizing Exercise Effectiveness in Fibromyalgia

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 26, 2007
Registry last updated
Apr 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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