Trial Outcomes & Findings for Memantine for Recurrent Glioblastoma (NCT NCT01260467)
NCT ID: NCT01260467
Last Updated: 2015-12-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
30 months
Results posted on
2015-12-10
Participant Flow
Participant milestones
| Measure |
Single Agent Memantine Group
memantine:10 milligrams orally twice a day
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Agent Memantine Group
memantine:10 milligrams orally twice a day
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Memantine for Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Single Agent Memantine Group
n=4 Participants
memantine:10 milligrams orally twice a day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 monthsPopulation: not evaluated due to poor patient accrual
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 monthsPopulation: not evaluated due to poor patient accrual
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsThis study will look at the number of participants who develop adverse events or side effects thought to be related to the memantine.
Outcome measures
| Measure |
Single Agent Memantine Group
n=4 Participants
memantine:10 milligrams orally twice a day
|
|---|---|
|
Number of Participants With Adverse Events
|
0 participants
|
Adverse Events
Single Agent Memantine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Serventi Research Associate
University of Rochester Medical Center
Phone: 585-276-3971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place