An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
Condition: Fibromyalgia, Primary
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

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 (ProvigilTM). There is considerable off label evidence for modafinil's
      ability to reduce fatigue related to multiple sclerosis, Parkinson's disease, cancer related
      fatigue, and depression related fatigue. There are preclinical studies showing that modafinil
      can alleviate fatigue secondary to medication side effects (diazepam, chlorpromazine). This
      multi-layered evidence base suggests that modafinil may be able to alleviate fatigue
      regardless of medical illness. Armodafinil now has four completed Phase III FDA regulatory
      studies revealing that it is well tolerated and effective for fatigue associated with
      obstructive sleep apnea (Effects of Armodafinil in the Treatment of Residual Excessive
      Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome: A 12-Week, Multicenter,
      Double-Blind, Randomized,Placebo-Controlled Study in nCPAP-Adherent Adults. Thomas Roth et
      al. Clinical Therapeutics/Volume 28, Number 5, 2006), shift work sleep disorder, and
      narcolepsy. Armodafinil is not yet FDA approved. It is felt to be a cleaner, safer, more
      potent isomer. Theoretically, fatigue is interpreted and possibly dictated centrally and
      armodafinil's proposed mechanism (similar to that of modafinil) of elevating central
      histamine activity may allow the brain to interpret a lower fatigue state, thus allowing
      patients to function better during the day with less peripheral fatigue.

      Fibromyalgia (FM) is an illness that may involve medical, rheumatological, autoimmune, sleep,
      endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger points.
      Greater than 90% of these patients will report fatigue as a key symptom as well. There are
      several investigation lines into the treatment of FM induced pain. Exercise, behavioral
      therapy, amitryptiline, duloxetine, tramadol, sodium oxybate all have randomized trials and
      almost all focus on pain. There are very few studies, if any, that look at FM induced fatigue
      which certainly ads to FM patients' daily incapacity and lowered productivity/quality of
      life.

      Armodafinil is a drug with minimal adverse effects (headache, insomnia, GI distress, anxiety,
      dry mouth, dizziness and an assumed low level addiction which is comparable to modafinil)
      which is well tolerated in current regulatory studies. It may have a safer tolerability
      profile than the FM medications noted above. As modafinil is often studied and often added as
      an augmentation agent to patients' regimens who suffer from fatigue in other medical
      illnesses, the authors feel that armodafinil would also be effective in this population. The
      authors wish to conduct a study to determine if armodafinil is safe and tolerable in the
      treatment of FM induced fatigue. This initial controlled study may allow for continued
      regulatory studies with this product in FM subjects. We propose a double-blind placebo
      controlled study to determine if armodafinil is safe and effective in reversing FM induced
      fatigue.
    


Intervention name(s): armodafinil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50-250mg/d; matching placebo
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fibromyalgia; fatigue