A Phase 2 interventional study of Armodafinil 150 mg/day and Placebo, in Fatigue and Chemotherapy Side Effects, sponsored by Cephalon. Terminated at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by Cephalon (part of Teva Pharmaceutical Industries, Ltd.) · Phase 2, Interventional, and Treatment
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
The primary objective of study was to determine whether armodafinil treatment at a dose of 150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving taxane chemotherapy alone or in combination with other agents by comparing the change from Screening cycle to treatment cycle (cycle 2) in the patient's average daily rating of their worst fatigue severity during the past 24 hours. In addition, the change in the percentage of days with severe fatigue and the mean Brief Fatigue Inventory scores were to be recorded.
2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.
This study's enrollment of 10 is below the median of 54 across 1,757 interventional studies indexed under Fatigue.
Browse Fatigue studies →Cephalon is the lead sponsor of 75 studies on the registry; none are open to participants now.
First submitted before Cephalon became part of Teva Pharmaceutical Industries, Ltd..
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents
Drug: Armodafinil 150 mg/day
* placebo * taxane chemotherapy treatment alone or in combination with other agents
Drug: Placebo,
Drug page: Modafinil
* 150 mg/day armodafinil * concurrent with one cycle of taxane chemotherapy alone or in combination with other agents * patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
* placebo * concurrent with one cycle of taxane chemotherapy alone or in combination with other agents * patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire
Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.
Time frame: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)
Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire
The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
Time frame: Duration of up to 8 weeks total (Screening and Double-Blind)
Change in the Brief Fatigue Inventory (BFI) Global Score
The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
Time frame: Duration of up to 8 weeks total (Screening and Double-Blind)
| Milestone | 150 mg/Day Armodafinil | Matching Placebo |
|---|---|---|
| Started | 6 | 4 |
| Completed | 6 | 4 |
| Not completed | 0 | 0 |
Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.
No measurements were reported for this outcome.
The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
No measurements were reported for this outcome.
The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
No measurements were reported for this outcome.
Collected over Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 150 mg/Day Armodafinil | — | 3/6 (50%) | 5/6 (83.3%) |
| Matching Placebo | — | 1/4 (25%) | 3/4 (75%) |
| Event | 150 mg/Day Armodafinil | Matching Placebo |
|---|---|---|
| Disease Progression (Prostate Cancer) / Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/6 | 1/4 |
| SyncopeNervous system disorders | 1/6 | 0/4 |
| IleusGastrointestinal disorders | 1/6 | 0/4 |
| Urinary Tract InfectionInfections and infestations | 1/6 | 0/4 |
| Event | 150 mg/Day Armodafinil | Matching Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/6 | 2/4 |
| LymphopeniaBlood and lymphatic system disorders | 0/6 | 1/4 |
| Abdominal painGastrointestinal disorders | 1/6 | 1/4 |
| DyspepsiaGastrointestinal disorders | 0/6 | 1/4 |
| NauseaGastrointestinal disorders | 1/6 | 1/4 |
| Chest painGeneral disorders | 0/6 | 1/4 |
| Skin turgor decreasedInvestigations | 0/6 | 1/4 |
| InsomniaPsychiatric disorders | 1/6 | 1/4 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/6 | 1/4 |
| HypertensionVascular disorders | 0/6 | 1/4 |
| Age, Categorical(Participants) | 150 mg/Day Armodafinil | Matching Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 4 | 10 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | 150 mg/Day Armodafinil | Matching Placebo | Total |
|---|---|---|---|
| Mean | 59.5 ± 3.73 | 56.5 ± 5.80 | 58.3 ± 4.62 |
| Sex: Female, Male(Participants) | 150 mg/Day Armodafinil | Matching Placebo | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 3 | 2 | 5 |
| Region of Enrollment(participants) | 150 mg/Day Armodafinil | Matching Placebo | Total |
|---|---|---|---|
| United States | 6 | 4 | 10 |
The record gives a start of Dec 2008, a primary completion of Oct 2009 and a completion of Feb 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2012, 2 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Modafinil