Expired Study
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Syracuse, New York 13210


Purpose:

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). This study is a blinded, placebo randomized study to see if armodafinil is more effective than placebo in the treatment of fatigue due to fibromyalgia. It is expected that armodafinil will provide greater relief of fatigue compared to placebo.


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, 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. Specific Aims and Hypotheses- 1- The author wishes complete a pilot study in regards to efficacy and safety in FM patients with fatigue. 2- We expect armodafinil to decrease patient reports of fatigue 3- We expect armodafinil to be well tolerated with low incidence of reported adverse effects and a low drop out rate. Main hypothesis- the author expects the use of armodafinil to decrease fatigue levels by 30% in a majority of fibromyalgia patients in this study. The principal measured to be used is brief fatigue inventory..


Criteria:

Inclusion Criteria: - 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: - 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


Study is Available At:


Original ID:

ArmoFibro-001a


NCT ID:

NCT00568919


Secondary ID:

001


Study Acronym:


Brief Title:

Armodafinil for Fibromyalgia Fatigue


Official Title:

An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

State University of New York - Upstate Medical University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Thomas l Schwartz, MD
Principal Investigator
SUNY Upstate

Study Dates

Start Date:September 2007
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:June 29, 2009
First Received Date:December 4, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Fatigue Severity SCale, Fibromylagia Impact Questionairre, Sheehan Disability SCale
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Brief Fatigue Inventory
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:armodafinil
Description:50mg active tablets, 1-5/d
Arm Name:B
Intervention Type:Drug
Name:Placebo
Description:inert placebo for armodafinil
Arm Name:A

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:A
Description:Inert Placebo Tablet
Study Arm Type:Active Comparator
Arm Name:B
Description:armodafinil study drug

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:State University of New York - Upstate Medical University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Martin Morell MD Arthritis Associates

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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