A Phase 3 interventional study of armodafinil 150 mg and Placebo in Fatigue, sponsored by Alliance for Clinical Trials in Oncology. Completed at 365 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.
Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue Brief Fatigue Inventory (BFI) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.
The secondary objectives of the study are listed below.
Patients will receive armodafinil or placebo for a total of 8 weeks.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 328 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 150 mg
Patients receive placebo orally every day in the morning for 8 weeks.
Other: Placebo
Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
Drug: armodafinil 250 mg
given orally
given orally
given orally
The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks.
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
Time frame: At 8 weeks
Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks.
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 4 weeks Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
Time frame: Up to 4 weeks
Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8
The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. Each neuropsychological measure was converted to an age-normative z score using published normative data. Impaired SDMT performance was defined as falling one standard deviation or more below the normative mean.
Time frame: Up to 8 weeks
Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8
Quality of life: Linear Analogue Self Assessment (LASA) will be analyzed comparing the total score for each treatment testing for change from baseline to four and eight weeks. Linear Analogue Self Assessment (LASA) is a 12 global QOL tool to which measures 10 subscales: overall QOL, physical well-being, fatigue, frequency and severity of pain, as well as social functioning and spiritual, emotional and mental well-being. All subscales were converted to a scale of 0-100, with higher scores indicating better QOL. Total score is the average of all 10 subscales.
Time frame: Up to 8 weeks
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Deemed at Least Possibly Related to Treatment Via the CTCAE Version 4.0
The number of participants who experienced at least one grade 3 or higher adverse events deemed at least possibly related to treatment via the CTCAE version 4.0
Time frame: Up to 8 weeks
| Milestone | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Started | 109 | 110 | 109 |
| Completed | 103 | 97 | 97 |
| Not completed | 6 | 13 | 12 |
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
| Participants | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. | 29 | 27 | 29 |
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 4 weeks Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
| Participants | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks. | 37 | 31 | 30 |
The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. Each neuropsychological measure was converted to an age-normative z score using published normative data. Impaired SDMT performance was defined as falling one standard deviation or more below the normative mean.
| units on a scale | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8 | 0.0 (-1.6 to 2.5) | 0.3 (-3.4 to 2.5) | 0.0 (-3.4 to 4.9) |
Quality of life: Linear Analogue Self Assessment (LASA) will be analyzed comparing the total score for each treatment testing for change from baseline to four and eight weeks. Linear Analogue Self Assessment (LASA) is a 12 global QOL tool to which measures 10 subscales: overall QOL, physical well-being, fatigue, frequency and severity of pain, as well as social functioning and spiritual, emotional and mental well-being. All subscales were converted to a scale of 0-100, with higher scores indicating better QOL. Total score is the average of all 10 subscales.
| units on a scale | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Baseline to Week 4 | 2.0 (-23.0 to 31.0) | 0.5 (-25.0 to 29.0) | 2.0 (-10.0 to 26.0) |
| Baseline to Week 8 | 4.0 (-32.0 to 26.0) | 3.0 (-16.0 to 27.0) | 2.0 (-15.0 to 27.0) |
The number of participants who experienced at least one grade 3 or higher adverse events deemed at least possibly related to treatment via the CTCAE version 4.0
| Participants | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Deemed at Least Possibly Related to Treatment Via the CTCAE Version 4.0 | 6 | 8 | 3 |
Collected over Up to 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (150 mg Armodafinil) | 0/109 (0%) | 12/109 (11%) | 55/109 (50.5%) |
| Arm II (250 mg Armodafinil) | 2/110 (1.8%) | 9/110 (8.2%) | 60/110 (54.5%) |
| Arm III (Placebo) | 1/109 (0.9%) | 8/109 (7.3%) | 42/109 (38.5%) |
| Event | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 2/109 | 3/110 | 1/109 |
| FallInjury, poisoning and procedural complications | 2/109 | 0/110 | 1/109 |
| DehydrationMetabolism and nutrition disorders | 2/109 | 0/110 | 1/109 |
| Edema cerebralNervous system disorders | 2/109 | 0/110 | 0/109 |
| SeizureNervous system disorders | 1/109 | 0/110 | 2/109 |
| Thromboembolic eventVascular disorders | 0/109 | 1/110 | 2/109 |
| FatigueGeneral disorders | 0/109 | 2/110 | 0/109 |
| VertigoEar and labyrinth disorders | 1/109 | 0/110 | 0/109 |
| Mucositis oralGastrointestinal disorders | 1/109 | 0/110 | 0/109 |
| NauseaGastrointestinal disorders | 0/109 | 1/110 | 1/109 |
| Event | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| HeadacheNervous system disorders | 42/109 | 46/110 | 35/109 |
| FatigueGeneral disorders | 9/109 | 7/110 | 2/109 |
| InsomniaPsychiatric disorders | 2/109 | 7/110 | 0/109 |
| NauseaGastrointestinal disorders | 5/109 | 4/110 | 1/109 |
| DizzinessNervous system disorders | 2/109 | 5/110 | 1/109 |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 1/109 | 4/110 | 1/109 |
| Platelet count decreasedInvestigations | 3/109 | 0/110 | 1/109 |
| White blood cell decreasedInvestigations | 3/109 | 0/110 | 1/109 |
| AnemiaBlood and lymphatic system disorders | 2/109 | 0/110 | 0/109 |
| Mucositis oralGastrointestinal disorders | 2/109 | 1/110 | 0/109 |
| Age, Continuous(years) | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | Total |
|---|---|---|---|---|
| Mean | 58.3 ± 11.92 | 56.9 ± 12.21 | 56.6 ± 12.8 | 57.3 ± 12.3 |
| Sex: Female, Male(Participants) | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | Total |
|---|---|---|---|---|
| Female | 46 | 46 | 43 | 135 |
| Male | 63 | 64 | 66 | 193 |
| Race/Ethnicity, Customized(Participants) | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | Total |
|---|---|---|---|---|
| Race — White | 101 | 105 | 104 | 310 |
| Race — Non-White | 8 | 5 | 5 | 18 |
| ECOG Performance Status(Participants) | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | Total |
|---|---|---|---|---|
| 0 | 18 | 28 | 23 | 69 |
| 1 | 60 | 58 | 62 | 180 |
| 2 | 23 | 22 | 16 | 61 |
| 3 | 8 | 2 | 8 | 18 |
Showing the first 100 of 365 sites.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD that underlie results in the publication PubMed ID 34882169.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology