Testing Mestinon and Exercise in Fibromyalgia

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00535587
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 178
• Location: 1
• Arms: 4
• Duration (Months): 69
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Behavioral: Exercise; Drug: pyridostigmine; Drug: Placibo; Behavioral: Attention Control	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 178 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Maximizing Exercise Effectiveness in Fibromyalgia
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Behavioral: Exercise; Drug: pyridostigmine; Other Names: Mestinon
Experimental: 2	Drug: pyridostigmine; Other Names: Mestinon ; Drug: Placibo
Experimental: 3	Behavioral: Exercise; Behavioral: Attention Control
Experimental: 4	Drug: Placibo; Behavioral: Attention Control

Outcome Measures

Primary Outcome Measures

1. Levels of Growth Hormone Post Exercise [6 months]

   Serum growth hormone at peak V02/treadmill

Secondary Outcome Measures

1. Improvement of Fibromyalgia Symptoms [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97219

Sponsors and Collaborators

• Oregon Health and Science University
• National Institute of Nursing Research (NINR)

Investigators

• Study Director: Edit Serfozo, MPH, Oregon Health and Science University
• Principal Investigator: Kim Dupree Jones, PhD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00535587
• Other Study ID Numbers: 5R01NR008150-04; R01NR008150
• First Posted: Sep 26, 2007
• Last Update Posted: Apr 18, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Fibromyalgia; Exercise; Mestinon
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Pyridostigmine Bromide

Study Results

Participant Flow

Arm/Group Title	Mestinon & Exercise	Mestinon and Attention Control	Placebo Pill and Exercise	Placebo Pill and Attention Control
Arm/Group Description
Period Title: Overall Study
STARTED	53	53	47	54
COMPLETED	43	42	39	41
NOT COMPLETED	10	11	8	13

Baseline Characteristics

Arm/Group Title	Mestinon & Exercise	Mestinon and Attention Control	Placebo Pill and Exercise	Placebo Pill and Attention Control	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	53	53	47	54	207
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	53 100%	53 100%	47 100%	54 100%	207 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49 (9)	49 (8)	50 (7)	49 (8)	49 (8)
Sex: Female, Male (Count of Participants)
Female	53 100%	49 92.5%	45 95.7%	54 100%	201 97.1%
Male	0 0%	4 7.5%	2 4.3%	0 0%	6 2.9%
Region of Enrollment (participants) [Number]
United States	53 100%	53 100%	47 100%	54 100%	207 100%

Outcome Measures

1. Primary Outcome

Title	Levels of Growth Hormone Post Exercise
Description	Serum growth hormone at peak V02/treadmill
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Mestinon/Exercise	Placebo Pill/Attention Control
Arm/Group Description
Measure Participants	43	41
Mean (Standard Deviation) [ng/ml]	4.95 (3.07)	1.41 (2.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mestinon/Exercise, Placebo Pill/Attention Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.02
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	.05
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 2.94
	Estimation Comments

2. Secondary Outcome

Title	Improvement of Fibromyalgia Symptoms
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Mestinon & Exercise		Mestinon and Attention Control		Placebo Pill and Exercise		Placebo Pill and Attention Control
Arm/Group Description
All Cause Mortality
	Mestinon & Exercise		Mestinon and Attention Control		Placebo Pill and Exercise		Placebo Pill and Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Mestinon & Exercise		Mestinon and Attention Control		Placebo Pill and Exercise		Placebo Pill and Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/36 (0%)		0/39 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Mestinon & Exercise		Mestinon and Attention Control		Placebo Pill and Exercise		Placebo Pill and Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/42 (0%)		0/39 (0%)		0/41 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.