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NCT00678691 · ClinicalTrials.gov registry record · Phase 4
An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
A Phase 4 study, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- Phase 4
- Development phase
- 55
- Enrollment target
NCT00678691 is a Phase 4 study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 55 participants.
The verdict
NCT00678691, a Phase 4 study, has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 55 participants
- Enrollment target
Study 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, sodi
Interventions
- DRUG placebo
- DRUG armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00678691
The ClinicalTrials.gov registry entry for NCT00678691 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Upstate Medical University, which has 113 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00678691 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00678691 about?
NCT00678691 is a clinical study titled "An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue". 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 m...
What is the current status of trial NCT00678691?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 55 participants. The study started on 2007-08. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00678691?
The interventions under investigation include: placebo (DRUG), armodafinil (DRUG).
Who is sponsoring clinical trial NCT00678691?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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