Testing Mestinon and Exercise in Fibromyalgia

Phase 2

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Exercise; Drug: Placibo; Behavioral: Attention Control; Drug: pyridostigmine

• Registration Number: NCT00535587
• Lead Sponsor: Oregon Health and Science University

Brief 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.

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-26
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2011-03
• Results First Submitted: 2011-03-21
• Results First Submitted QC: 2011-03-23
• Last Update Submitted: 2011-03-23
• Results First Posted: 2011-04-18
• Last Update Posted: 2011-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• Have Fibromyalgia

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Exercise	-
3	Exercise	-
3	Attention Control	-
4	Placibo	-
4	Attention Control	-
1	pyridostigmine	-
2	pyridostigmine	-
2	Placibo	-

Primary Outcome Measures

Name	Time	Method
Levels of Growth Hormone Post Exercise	6 months	Serum growth hormone at peak V02/treadmill

Secondary Outcome Measures

Name	Time	Method
Improvement of Fibromyalgia Symptoms	6 months

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States