Trial Outcomes & Findings for An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue (NCT NCT00678691)

NCT ID: NCT00678691

Last Updated: 2014-12-18

Results Overview

This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2014-12-18

Participant Flow

Subjects were easily recruited and screened for study entry

Subjects were exluded after informed consent if medical confounding variables or safety variables were found

Participant milestones

Measure	A,1 Armodafinil Study Drug 50-250mg Flexible Dose armodafinil	A,2 Matching Placebo placebo
Overall Study STARTED	27	28
Overall Study COMPLETED	21	24
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Measure	A,1 Armodafinil Study Drug 50-250mg Flexible Dose armodafinil	A,2 Matching Placebo placebo
Overall Study Adverse Event	6	4

Baseline Characteristics

An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue

Baseline characteristics by cohort

Measure	A,1 Armodafinil Study Drug n=27 Participants armodafinil	A,2 Matching Placebo n=28 Participants placebo	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 4 • n=5 Participants	47 years STANDARD_DEVIATION 4 • n=7 Participants	49 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	28 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: last observation carried forward after power analysis calculated

This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue

Outcome measures

Measure	A,1 Armodafinil Study Drug n=27 Participants armodafinil	A,2 Matching Placebo n=28 Participants placebo
Brief Fatigue Inventory	2.86 units on a scale Standard Deviation .149	4.29 units on a scale Standard Deviation .144

Adverse Events

A,1 Armodafinil Study Drug

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

A,2 Matching Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	A,1 Armodafinil Study Drug n=27 participants at risk armodafinil	A,2 Matching Placebo n=28 participants at risk placebo
Vascular disorders headache	14.8% 4/27 • 8 weeks	10.7% 3/28 • 8 weeks
Gastrointestinal disorders dry mouth	11.1% 3/27 • 8 weeks	10.7% 3/28 • 8 weeks
Psychiatric disorders Poor Concentration	7.4% 2/27 • 8 weeks	7.4% 2/27 • 8 weeks

Additional Information

Thomas Schwartz

SUNY Upstate Medical University

Phone: 3154643166

Email: schwartt@upstate.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place