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Phase 4
18 Years
65 Years
Not Enrolling
Fibromyalgia, Primary

Thank you

Trial Information

Inclusion Criteria:

- If possible, 60 subjects will be included in this study.

- All males/females of any race are eligible if aged between 18 and 65 and

- Subjects must speak English and have capacity to receive and utilize informed consent

- Agree to use barrier method contraception or are infertile x2 years due to medical
condition or surgery

- Have been formally diagnosed by a Board Certified Rheumatologist using the ACR 1990
research criteria for fibromylagia

- Report that fatigue, in addition to FM pain is a key distressing symptom of their FM

- Have a score of >4 on the Brief Fatigue Inventory (BFI)

- Women of child bearing potential must agree to use barrier contraception as
armodafinil may decrease the effectiveness of oral contraceptives

Exclusion Criteria:

- Exclusion: Subjects cannot

- Be pregnant or be attempting to conceive at present (urine bHCG must be negative)

- Have an active substance abuse problem with last use within the past 180 days
(outside of nicotine)

- Use other stimulating medication ie stimulants, caffeine products (this refers to OTC
stimulants OR patients clinically tolerant to and withdrawing from caffeinated
beverages, bupropion, desipramine, etc UNLESS said drug has been in steady dosing for
>4 weeks

- Have a known medical condition outside of FM that causes fatigue (i.e. obstructive
apnea, hypothyroidism, depression, etc)

- Have a known medical condition or other medication use that relatively
contraindicates armodafinil use (ie substance abuse, sensitivity to armodafinil,
known cardiac abnormalities of left ventricular hypertrophy, recent MI, mitral valve
prolapse dependent on stimulant use, history of psychosis

- Has a prior history of modafinil use and failure

- Be receiving daytime sedating medication with clear chronological impact on fatigue
UNLESS fatigue predates sedating medication or said medication has been steadily
dosed > 4 weeks

- Medications that induce/inhibit p450 3A4 as they may alter armodafinil plasma levels,
and vica versa

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Brief Fatigue Inventory

Outcome Time Frame:


Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

December 2009

Related Keywords:

  • Fibromyalgia, Primary
  • fibromyalgia
  • fatigue
  • Fibromyalgia
  • Myofascial Pain Syndromes



SUNY Upstate Medical University Syracuse, New York  13210