Fibromyalgia, PrimaryPhase 4NCT00678691
An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
A Phase 4 study testing armodafinil in people with Fibromyalgia, Primary, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- armodafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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.
- Conditions
- Fibromyalgia, Primary
- Being tested
- armodafinil, placebo
- Keywords
- fibromyalgia, fatigue
- Medical subject headings
- Fibromyalgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
armodafinilDrug
50-250mg/d
placeboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| A,1 | Experimental | armodafinil Receives: Drug: armodafinil |
| A,2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Fatigue Inventory
This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678691
- Sponsor's protocol ID
- ArmoFibro-001
- Status last verified
- Dec 2014
- First submitted
- 13 May 2008
- Last updated
- 18 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
- ClinicalTrials.gov ID
- NCT00678691
- Acronym / sponsor ID
- ArmoFibro-001
- Conditions
- Fibromyalgia, Primary
- Keywords
- fibromyalgia, fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 18 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A,1 | Experimental | Drug: armodafinilarmodafinil |
| A,2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| armodafinil50-250mg/d | Drug | A,1 |
| placebomatching placebo | Drug | A,2 |
Primary outcome
Brief Fatigue Inventory
Time frame: 8 weeks
This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Fibromyalgia, Primary
Not yet recruiting
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
Hyperthermia, Chronic Primary Pain
Recruiting
The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients
Fibromyalgia, Fibromyalgia (FM)
RecruitingEarly Phase 1
Psilocybin-facilitated Treatment for Chronic Pain
Fibromyalgia, Primary
Active, not recruitingObservational study
ATI Evidence-based Guide Investigating Clinical Services
Primary Body Region (Arranged Most Common to Least), Lumbar/SI
Not yet recruiting
The Effects of Inspiratory Muscle Training Female Patients With Fibromyalgia
Fibromyalgia, Autonomic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing armodafinil in people with Fibromyalgia, Primary, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Fatigue Inventory (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.