Phase 2 N=207 Randomized Double-blind Treatment

Testing Mestinon and Exercise in Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT00535587 ↗

Enrolled (actual)

207

Serious AEs

0.0%

Results posted

Apr 2011

Primary outcome: Primary: Levels of Growth Hormone Post Exercise — 4.95; 1.41 ng/ml — p=<0.02

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Exercise (Behavioral); pyridostigmine (Drug); Placibo (Drug); Attention Control (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Levels of Growth Hormone Post Exercise	4.95; 1.41	<0.02 sig
SECONDARY Improvement of Fibromyalgia Symptoms	—	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00535587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.