NCT00535587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 18, 2011

Completed
Last Updated

April 18, 2011

Status Verified

March 1, 2011

Enrollment Period

5.8 years

First QC Date

September 21, 2007

Results QC Date

March 21, 2011

Last Update Submit

March 23, 2011

Conditions

Fibromyalgia

Keywords

FibromyalgiaExerciseMestinon

Outcome Measures

Primary Outcomes (1)

  • Levels of Growth Hormone Post Exercise

    Serum growth hormone at peak V02/treadmill

    6 months

Secondary Outcomes (1)

  • Improvement of Fibromyalgia Symptoms

    6 months

Study Arms (4)

1

EXPERIMENTAL
Behavioral: ExerciseDrug: pyridostigmine

2

EXPERIMENTAL
Drug: pyridostigmineDrug: Placibo

3

EXPERIMENTAL
Behavioral: ExerciseBehavioral: Attention Control

4

EXPERIMENTAL
Drug: PlaciboBehavioral: Attention Control

Interventions

ExerciseBEHAVIORAL
13
pyridostigmineDRUG
Also known as: Mestinon
12
PlaciboDRUG
24
Attention ControlBEHAVIORAL
34

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have Fibromyalgia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97219, United States

Location

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

ExercisePyridostigmine Bromide

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

6 discontinued due to medical reasons unrelated to the study 4 were unwilling to complete 1 relocated

Results Point of Contact

Title
Kim Dupree Jones
Organization
Oregon Health & Science University
joneskim@ohsu.edu
503 494 3837

Study Officials

  • Edit Serfozo, MPH

    Oregon Health and Science University

    STUDY DIRECTOR

  • Kim Dupree Jones, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 26, 2007

Study Start

September 1, 2002

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 18, 2011

Results First Posted

April 18, 2011

Record last verified: 2011-03

Locations

US(1)