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A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Oncotherapeutics
ClinicalTrials.gov Identifier:
NCT01160380
First received: July 7, 2010
Last updated: November 5, 2014
Last verified: October 2014
Results First Received: October 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Fatigue
Multiple Myeloma
Interventions: Drug: armodafinil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Armodafinil

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

Placebo-First

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.


Participant Flow:   Overall Study
    Armodafinil     Placebo-First  
STARTED     25     25  
COMPLETED     17     20  
NOT COMPLETED     8     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Armodafinil

The patients receive armodafinil for all 56 days of the study.

armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

Placebo-First

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

Total Total of all reporting groups

Baseline Measures
    Armodafinil     Placebo-First     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 1.8     67  ± 2.3     65  ± 2.1  
Gender  
[units: participants]
     
Female     14     15     29  
Male     11     10     21  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     7     1     8  
White     17     20     37  
More than one race     0     0     0  
Unknown or Not Reported     1     3     4  
ECOG (Eastern Cooperative Oncology Group) [1]
[units: paarticipants]
     
0     5     7     12  
1     18     17     35  
2     2     1     3  
Fatigue (baseline)-Brief Fatigue Inventory (BFI) [2]
[units: units on a scale]
Median ( Full Range )
  59  
  ( 39 to 83 )  
  60.5  
  ( 36 to 79 )  
  60  
  ( 36 to 83 )  
Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10) [3]
[units: units on a scale]
Median ( Full Range )
  9  
  ( 6 to 12 )  
  9  
  ( 6 to 12 )  
  9  
  ( 6 to 12 )  
[1]

Grade ECOG Performance status

0 Fully active, performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
  4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
  5. Dead
[2] BFI scale: 9 items; range=0-90 (0-10 per item) Mild = 1-3 Moderate = 4-7 Severe = 8-10
[3] ICD-10 Criteria (Range: 0-14) A1-A11 Fatigue Criteria B. Clinically significant distress or impaired functioning C. Symptoms are a consequence of cancer or cancer therapy D. Symptoms are a consequence of comorbid psychiatric disorders



  Outcome Measures
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1.  Primary:   BFI Score   [ Time Frame: Day 1, Day 28 and Day 56 ]

2.  Primary:   Trail Making Test B Score (TMT-B)   [ Time Frame: Day 1, Day 28 and Day 56 ]

3.  Primary:   Symbol Digit Modalities Test Score (SDMT)   [ Time Frame: Day 1, Day 28 and Day 56 ]

4.  Primary:   Digit Span Test Score   [ Time Frame: Day 1, Day 28 and Day 56 ]

5.  Secondary:   Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score   [ Time Frame: Day 1, Day 28 and Day 56 ]

6.  Secondary:   Hospital Anxiety and Depression Scale (HADS) Score   [ Time Frame: Day 1, Day 28 and Day 56 ]

7.  Secondary:   Epworth Sleepiness Scale (ESS) Score   [ Time Frame: Day 1, Day 28 and Day 56 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: Oncotherapeutics
phone: 310-623-1200
e-mail: lthulin@oncotherapeutics.com


No publications provided


Responsible Party: Oncotherapeutics
ClinicalTrials.gov Identifier: NCT01160380     History of Changes
Other Study ID Numbers: C10953/6270
Study First Received: July 7, 2010
Results First Received: October 22, 2014
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board