Testing Mestinon and Exercise in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Maximizing Exercise Effectiveness in Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535587
• Other study ID #: 5R01NR008150-04
• Secondary ID: R01NR008150
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2007
• Last updated: March 23, 2011
• Start date: September 2002
• Est. completion date: June 2008

Study information

• Verified date: March 2011
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Exercise

Drug:
• pyridostigmine

• Placibo

Behavioral:
• Attention Control

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Growth Hormone Post Exercise	Serum growth hormone at peak V02/treadmill	6 months	No
Secondary	Improvement of Fibromyalgia Symptoms		6 months	No