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Trial record 13 of 239 for:    (armodafinil)

Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

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ClinicalTrials.gov Identifier: NCT01400958
Recruitment Status : Terminated (Slow Accrual, Initiating Principal Investigator (PI) left Moffitt)
First Posted : July 25, 2011
Results First Posted : December 16, 2013
Last Update Posted : December 16, 2013
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Malignant Glioma
Interventions Drug: Nuvigil®
Drug: Placebo
Enrollment 6
Recruitment Details Study was Open to Accrual at Moffitt Cancer Center 12/22/2010 to 12/28/2012.
Pre-assignment Details  
Arm/Group Title Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo
Hide Arm/Group Description Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34). Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
Period Title: Overall Study
Started 3 3
Completed 2 1
Not Completed 1 2
Reason Not Completed
Physician Decision             0             1
Withdrawal by Subject             0             1
Adverse Event             1             0
Arm/Group Title Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo Total
Hide Arm/Group Description Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34). Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34). Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
All participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
1
  33.3%
3
  50.0%
>=65 years
1
  33.3%
2
  66.7%
3
  50.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
59
(48 to 66)
65
(53 to 72)
62
(48 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
2
  66.7%
0
   0.0%
2
  33.3%
Male
1
  33.3%
3
 100.0%
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
1.Primary Outcome
Title Occurrence of Improved Fatigue Experience After Treatment
Hide Description Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine).
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Available, evaluable participants with minimal fatigue at baseline
Arm/Group Title Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo
Hide Arm/Group Description:
Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Occurrence of Improved Cognitive Performance
Hide Description Determine if Nuvigil® improves cognitive function of patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained average (T=50) to slightly below average (T=40 or greater) cognitive function.
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Available, evaluable participants with average T Score range cognitive function at baseline
Arm/Group Title Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo
Hide Arm/Group Description:
Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame 1 year, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo
Hide Arm/Group Description Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34). Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
All-Cause Mortality
Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      1/3 (33.33%)    
Cardiac disorders     
Supraventricular tachycardia  1  1/3 (33.33%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonitis  1 [1]  0/3 (0.00%)  0 1/3 (33.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
[1]
occurred prior to taking study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Comparator: A: Nuvigil® Placebo Comparator: B: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      2/3 (66.67%)    
Ear and labyrinth disorders     
Hearing impaired  1  0/3 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders     
Nausea  1  2/3 (66.67%)  2 1/3 (33.33%)  1
Constipation  1  0/3 (0.00%)  0 2/3 (66.67%)  2
Diarrhea  1  2/3 (66.67%)  2 0/3 (0.00%)  0
Salivary duct inflammation  1  0/3 (0.00%)  0 1/3 (33.33%)  1
Vomiting  1  1/3 (33.33%)  2 0/3 (0.00%)  0
General disorders     
Fatigue  1  2/3 (66.67%)  3 2/3 (66.67%)  2
Edema limbs  1  1/3 (33.33%)  2 1/3 (33.33%)  1
Infections and infestations     
Nail infection  1  1/3 (33.33%)  1 0/3 (0.00%)  0
Vaginal infection  1  1/3 (33.33%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness lower limb  1  0/3 (0.00%)  0 1/3 (33.33%)  1
Pain in extremity  1  0/3 (0.00%)  0 1/3 (33.33%)  1
Nervous system disorders     
Nervous system disorders - Other  1  2/3 (66.67%)  5 0/3 (0.00%)  0
Ataxia  1  1/3 (33.33%)  1 0/3 (0.00%)  0
Peripheral sensory neuropathy  1  0/3 (0.00%)  0 1/3 (33.33%)  1
Psychiatric disorders     
Agitation  1  2/3 (66.67%)  2 0/3 (0.00%)  0
Insomnia  1  1/3 (33.33%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  1/3 (33.33%)  1 0/3 (0.00%)  0
Rash acneiform  1  1/3 (33.33%)  1 1/3 (33.33%)  2
Dry skin  1  1/3 (33.33%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Planned accrual of 60 participants for analysis was not met. Recruitment was closed early due to slow accrual and initiating Principal Investigator (PI) leaving Moffitt.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Peter A. Forsyth, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3063
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01400958     History of Changes
Other Study ID Numbers: MCC-16233
C10953/6253 ( Other Identifier: Cephalon, Inc. )
First Submitted: July 21, 2011
First Posted: July 25, 2011
Results First Submitted: August 6, 2013
Results First Posted: December 16, 2013
Last Update Posted: December 16, 2013