Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries ( Cephalon )

ClinicalTrials.gov Identifier:

NCT00825227

First received: January 15, 2009

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Results First Received: July 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Fatigue Chemotherapy Side Effects
Interventions:	Drug: Armodafinil 150 mg/day Drug: Placebo,

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
150 mg/Day Armodafinil	150 mg/day armodafinil taxane chemotherapy treatment alone or in combination with other agents
Matching Placebo	placebo taxane chemotherapy treatment alone or in combination with other agents
Total	Total of all reporting groups

Baseline Measures

	150 mg/Day Armodafinil	Matching Placebo	Total
Number of Participants [units: participants]	6	4	10
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	4	10
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	59.5 ± 3.73	56.5 ± 5.80	58.3 ± 4.62
Gender [units: participants]
Female	3	2	5
Male	3	2	5
Region of Enrollment [units: participants]
United States	6	4	10

Outcome Measures

1. Primary:

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 [ Time Frame: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind) ]

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2. Secondary:

Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire [ Time Frame: Duration of up to 8 weeks total (Screening and Double-Blind) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Change in the Brief Fatigue Inventory (BFI) Global Score [ Time Frame: Duration of up to 8 weeks total (Screening and Double-Blind) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.

Results Point of Contact:

Name/Title: Vice President, Clinical Research
Organization: Cephalon, Inc.
phone: 1-800-896-5855

No publications provided

Responsible Party:	Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:	NCT00825227 History of Changes
Other Study ID Numbers:	C10953/2036/ON/US
Study First Received:	January 15, 2009
Results First Received:	July 28, 2011
Last Updated:	June 21, 2012
Health Authority:	United States: Food and Drug Administration

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