Status:
COMPLETED
An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
Lead Sponsor:
State University of New York - Upstate Medical University
Conditions:
Fibromyalgia, Primary
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Armodafinil (NuvigilTM) is an isomer of a drug currently approved by the FDA for the treatment of fatigue secondary to narcolepsy, sleep apnea, and shift work sleep disorder called modafinil (Provigil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00678691
Start Date
August 1 2007
End Date
December 1 2009
Last Update
December 18 2014
Active Locations (1)
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1
SUNY Upstate Medical University
Syracuse, New York, United States, 13210