Testing Mestinon and Exercise in Fibromyalgia

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: Placibo; Behavioral: Attention Control; Behavioral: Exercise; Drug: pyridostigmine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00535587

R01NR008150 (U.S. NIH Grant/Contract)

5R01NR008150-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

178 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: pyridostigmine

Behavioral: Exercise

2

Experimental group

Treatment:

Drug: pyridostigmine

Drug: Placibo

3

Experimental group

Treatment:

Behavioral: Attention Control

Behavioral: Exercise

4

Experimental group

Treatment:

Behavioral: Attention Control

Drug: Placibo