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Testing Mestinon and Exercise in Fibromyalgia

This study has been completed.
National Institute of Nursing Research (NINR)
Information provided by:
Oregon Health and Science University Identifier:
First received: September 21, 2007
Last updated: March 23, 2011
Last verified: March 2011
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.

Condition Intervention Phase
Fibromyalgia Behavioral: Exercise Drug: pyridostigmine Drug: Placibo Behavioral: Attention Control Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Maximizing Exercise Effectiveness in Fibromyalgia

Resource links provided by NLM:

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Levels of Growth Hormone Post Exercise [ Time Frame: 6 months ]
    Serum growth hormone at peak V02/treadmill

Secondary Outcome Measures:
  • Improvement of Fibromyalgia Symptoms [ Time Frame: 6 months ]

Enrollment: 178
Study Start Date: September 2002
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Exercise Drug: pyridostigmine
Other Name: Mestinon
Experimental: 2 Drug: pyridostigmine
Other Name: Mestinon
Drug: Placibo
Experimental: 3 Behavioral: Exercise Behavioral: Attention Control
Experimental: 4 Drug: Placibo Behavioral: Attention Control

Detailed Description:
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.

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00535587

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97219
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Nursing Research (NINR)
Study Director: Edit Serfozo, MPH Oregon Health and Science University
Principal Investigator: Kim Dupree Jones, PhD Oregon Health and Science University
  More Information

Responsible Party: Kim Dupree Jones PhD, Associate Professor, Oregon Health & Science University, School of Nursing Identifier: NCT00535587     History of Changes
Other Study ID Numbers: 5R01NR008150-04 ( U.S. NIH Grant/Contract )
R01NR008150 ( U.S. NIH Grant/Contract )
Study First Received: September 21, 2007
Results First Received: March 21, 2011
Last Updated: March 23, 2011

Keywords provided by Oregon Health and Science University:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pyridostigmine Bromide
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on September 21, 2017