An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
State University of New York - Upstate Medical University