Trial Outcomes & Findings for Nuvigil or Placebo in Newly Diagnosed Malignant Glioma (NCT NCT01400958)
NCT ID: NCT01400958
Last Updated: 2013-12-16
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
5 months
Results posted on
2013-12-16
Participant Flow
Study was Open to Accrual at Moffitt Cancer Center 12/22/2010 to 12/28/2012.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Nuvigil or Placebo in Newly Diagnosed Malignant Glioma
Baseline characteristics by cohort
| Measure |
Active Comparator: A: Nuvigil®
n=3 Participants
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
n=3 Participants
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
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
59 years
n=5 Participants
|
65 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: Available, evaluable participants with minimal fatigue at baseline
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).
Outcome measures
| Measure |
Active Comparator: A: Nuvigil®
n=1 Participants
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
n=1 Participants
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).
|
|---|---|---|
|
Occurrence of Improved Fatigue Experience After Treatment
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: Available, evaluable participants with average T Score range cognitive function at baseline
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.
Outcome measures
| Measure |
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
n=1 Participants
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).
|
|---|---|---|
|
Occurrence of Improved Cognitive Performance
|
—
|
1 participants
|
Adverse Events
Active Comparator: A: Nuvigil®
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Comparator: B: Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Comparator: A: Nuvigil®
n=3 participants at risk
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
n=3 participants at risk
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).
|
|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
Other adverse events
| Measure |
Active Comparator: A: Nuvigil®
n=3 participants at risk
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
n=3 participants at risk
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).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 1 year, 9 months
|
66.7%
2/3 • Number of events 2 • 1 year, 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/3 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 2 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • 1 year, 9 months
|
66.7%
2/3 • Number of events 2 • 1 year, 9 months
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 2 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
66.7%
2/3 • Number of events 5 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Nervous system disorders
Ataxia
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
33.3%
1/3 • Number of events 2 • 1 year, 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Infections and infestations
Nail infection
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Infections and infestations
Vaginal infection
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • 1 year, 9 months
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
|
Psychiatric disorders
Agitation
|
66.7%
2/3 • Number of events 2 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • 1 year, 9 months
|
0.00%
0/3 • 1 year, 9 months
|
Additional Information
Peter A. Forsyth, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3063
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place