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Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

This study has been terminated.
(Slow Accrual, Initiating Principal Investigator (PI) left Moffitt)
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01400958
First received: July 21, 2011
Last updated: October 25, 2013
Last verified: October 2013
Results First Received: August 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Malignant Glioma
Interventions: Drug: Nuvigil®
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
Study was Open to Accrual at Moffitt Cancer Center 12/22/2010 to 12/28/2012.

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
Active Comparator: A: Nuvigil® 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).
Placebo Comparator: B: Placebo 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).

Participant Flow:   Overall Study
    Active Comparator: A: Nuvigil®     Placebo Comparator: B: Placebo  
STARTED     3     3  
COMPLETED     2     1  
NOT COMPLETED     1     2  
Physician Decision                 0                 1  
Withdrawal by Subject                 0                 1  
Adverse Event                 1                 0  



  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.
All participants

Reporting Groups
  Description
Active Comparator: A: Nuvigil® 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).
Placebo Comparator: B: Placebo 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 Total of all reporting groups

Baseline Measures
    Active Comparator: A: Nuvigil®     Placebo Comparator: B: Placebo     Total  
Number of Participants  
[units: participants]
  3     3     6  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     1     3  
>=65 years     1     2     3  
Age  
[units: years]
Mean ( Full Range )
  59  
  ( 48 to 66 )  
  65  
  ( 53 to 72 )  
  62  
  ( 48 to 72 )  
Gender  
[units: participants]
     
Female     2     0     2  
Male     1     3     4  
Region of Enrollment  
[units: participants]
     
United States     3     3     6  



  Outcome Measures
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1.  Primary:   Occurrence of Improved Fatigue Experience After Treatment   [ Time Frame: 5 months ]

2.  Secondary:   Occurrence of Improved Cognitive Performance   [ Time Frame: 5 months ]


  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
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.


  More Information
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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
e-mail: peter.forsyth@moffitt.org


No publications provided


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
Study First Received: July 21, 2011
Results First Received: August 6, 2013
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board