CLINICAL TRIALS PROFILE FOR ARMODAFINIL

All Clinical Trials for Armodafinil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00078312 ↗	Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder	Completed	Cephalon	Phase 3	2004-01-01	The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD).
NCT00078325 ↗	Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)	Completed	Cephalon	Phase 3	2004-02-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.
NCT00078377 ↗	Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy	Completed	Cephalon	Phase 3	2004-03-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)
NCT00079677 ↗	Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome	Completed	Cephalon	Phase 3	2004-03-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).
NCT00080288 ↗	Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD	Completed	Cephalon	Phase 3	2004-03-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.
NCT00228553 ↗	Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness	Completed	Cephalon	Phase 3	2004-05-01	A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
NCT00228566 ↗	Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome	Completed	Cephalon	Phase 3	2005-10-01	The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.

Clinical Trial Conditions for Armodafinil

Condition Name

Condition Name for Armodafinil
Intervention	Trials
Fatigue	10
Obstructive Sleep Apnea	6
Narcolepsy	6
Excessive Sleepiness	5

Condition MeSH

Condition MeSH for Armodafinil
Intervention	Trials
Sleepiness	16
Fatigue	15
Disorders of Excessive Somnolence	12
Sleep Apnea, Obstructive	9

Clinical Trial Locations for Armodafinil

Trials by Country

Trials by Country for Armodafinil
Location	Trials
United States	427
Canada	7
France	5
Bulgaria	4
Australia	4

Trials by US State

Trials by US State for Armodafinil
Location	Trials
New York	23
California	22
Texas	22
Pennsylvania	21
Ohio	19

Clinical Trial Progress for Armodafinil

Clinical Trial Phase

Clinical Trial Phase for Armodafinil
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	19
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Armodafinil
Clinical Trial Phase	Trials
Completed	44
Terminated	9
Withdrawn	3

Clinical Trial Sponsors for Armodafinil

Sponsor Name

Sponsor Name for Armodafinil
Sponsor	Trials
Cephalon	31
National Cancer Institute (NCI)	9
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for Armodafinil
Sponsor	Trials
Other	45
Industry	43
NIH	11

Armodafinil: Clinical Trials, Market Analysis, and Projections

Introduction to Armodafinil

Armodafinil, the R-enantiomer of modafinil, is a wakefulness-promoting agent used primarily to treat sleep disorders such as narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Cancer-Related Fatigue Trial

A significant clinical trial worth noting is the phase 3 randomized, double-blinded, placebo-controlled trial that investigated the efficacy of armodafinil in reducing cancer-related fatigue in patients with high-grade glioma. This trial, conducted from June 2013 to December 2019, involved patients who were clinically stable at least 4 weeks after completing radiation therapy and had moderate-to-severe fatigue.

• Methodology: Patients were randomized to receive either 150 mg or 250 mg of armodafinil daily or a placebo over 8 weeks. The primary outcome was the proportion of patients achieving a clinically meaningful improvement in fatigue, defined as a 2-point reduction on the Brief Fatigue Inventory scale[1][4].
• Results: The trial found no meaningful benefit of armodafinil at either dose for treating fatigue in these patients. The study faced limitations, including high attrition rates due to adverse effects and perceived limited efficacy, but these were deemed unlikely to affect the overall outcome[1].

Market Analysis

Current Market Size and Growth

The armodafinil market has been growing steadily, driven by increasing awareness of sleep disorders and the demand for cognitive enhancers. As of 2023, the global market size for armodafinil has reached approximately $1.1 billion[2].

• Geographical Trends: North America, particularly the United States, holds a substantial share of the market due to advanced healthcare infrastructure and rising healthcare expenditure. The Asia-Pacific region, especially China and India, is showing promising growth potential due to increasing healthcare expenditures and changing attitudes toward mental health[2].
• Segmentation: The market is segmented by product types (50 mg, 150 mg, 200 mg, and 250 mg tablets) and applications (OSA, narcolepsy, SWSD, and others). The 150 mg and 200 mg tablets are most commonly prescribed for conditions like narcolepsy and OSA[2].

Market Drivers and Challenges

• Drivers: The market is driven by the increasing prevalence of sleep disorders, growing recognition of cognitive enhancers, and advancements in formulation technologies. Emerging applications, such as managing Attention Deficit Hyperactivity Disorder (ADHD) and enhancing performance in high-stakes environments, also contribute to market growth[2].
• Challenges: Stringent regulatory approvals, concerns over potential side effects, competition from alternative cognitive enhancers, and generic formulations pose challenges to the market. Despite these, the market presents lucrative opportunities, especially in emerging economies[2].

Competitive Landscape

The armodafinil market is dominated by major pharmaceutical companies such as Teva, Mylan, Apotex, Lupin, Sandoz, Natco Pharma, and Aurobindo. Teva holds a significant market share, employing aggressive pricing strategies and an extensive distribution network. Mylan and Apotex follow closely, leveraging their established generics portfolios. Emerging challengers like Aurobindo and Natco Pharma are notable for their innovative approaches in formulation and marketing[2].

Market Projections

Growth Forecast

The armodafinil market is projected to exhibit a compound annual growth rate (CAGR) of 4.50% during the forecast period from 2024 to 2031. This growth is spurred by ongoing research, the introduction of generic drugs, and an evolving regulatory landscape that fosters greater accessibility to treatment options[2].

• Regional Growth: The Asia-Pacific region is expected to be the fastest-growing, driven by rising healthcare expenditures and shifting cultural attitudes toward mental health. North America and Europe will continue to be significant markets due to robust healthcare systems and increasing awareness of wakefulness-promoting agents[2].

Emerging Trends

• Nootropics and Cognitive Enhancers: There is an increasing interest in nootropics and cognitive enhancers, particularly in professional sectors requiring high levels of focus and productivity. This trend is expected to drive demand for armodafinil beyond traditional sleep disorders[2].
• Novel Applications: Research into novel applications of armodafinil, such as managing ADHD and enhancing performance in various high-stakes environments, is expected to expand the market further[2].

Regulatory Status

Armodafinil is approved in several countries for indications including narcolepsy, OSA, and SWSD. In the United States, it is approved as an adjunct to standard treatment for OSA and as a treatment for excessive sleepiness associated with narcolepsy and SWSD[3].

• International Regulatory Status: The drug has varying regulatory statuses in different countries, with approvals in the US, Colombia, and Puerto Rico, and ongoing evaluations or rejections in other regions due to local requirements[3].

Key Takeaways

• Clinical Trials: Recent clinical trials have shown no meaningful benefit of armodafinil in reducing cancer-related fatigue in patients with high-grade glioma.
• Market Size and Growth: The global armodafinil market size is approximately $1.1 billion as of 2023, with a projected CAGR of 4.50% from 2024 to 2031.
• Market Drivers: Increasing prevalence of sleep disorders, growing recognition of cognitive enhancers, and advancements in formulation technologies drive the market.
• Challenges: Stringent regulatory approvals, concerns over side effects, and competition from generics pose challenges.
• Regional Growth: The Asia-Pacific region is expected to be the fastest-growing market.

FAQs

What is armodafinil used for?

Armodafinil is primarily used to treat sleep disorders such as narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD).

Did the clinical trial on cancer-related fatigue show any benefit of armodafinil?

No, the phase 3 clinical trial found no meaningful benefit of armodafinil in reducing cancer-related fatigue in patients with high-grade glioma[1].

What is the projected growth rate of the armodafinil market?

The armodafinil market is projected to exhibit a CAGR of 4.50% from 2024 to 2031[2].

Which regions are expected to drive the growth of the armodafinil market?

The Asia-Pacific region, particularly China and India, is expected to be the fastest-growing market, followed by North America and Europe[2].

What are the main challenges facing the armodafinil market?

The market faces challenges including stringent regulatory approvals, concerns over potential side effects, competition from alternative cognitive enhancers, and generic formulations[2].

Sources

1. JAMA Oncology: "Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-Grade Glioma: A Randomized Clinical Trial"[1].
2. OpenPR: "Comprehensive Growth Forecast for Armodafinil Market: Segmentation Analysis and Market Trends (2024 - 2031)"[2].
3. Therapeutic Goods Administration: "Australian Public Assessment Report for Armodafinil"[3].
4. ClinicalTrials.gov: "Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma"[4].