Trial Outcomes & Findings for P-glycoprotein Inhibition as Adjunct Treatment for Medically Refractory Epilepsy. (NCT NCT00524134)
NCT ID: NCT00524134
Last Updated: 2016-05-23
Results Overview
TERMINATED
PHASE2/PHASE3
6 participants
12 weeks at highest tolerated dose
2016-05-23
Participant Flow
The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.
Participant milestones
| Measure |
Carvedilol-CR
Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Carvedilol-CR
Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
P-glycoprotein Inhibition as Adjunct Treatment for Medically Refractory Epilepsy.
Baseline characteristics by cohort
| Measure |
Carvedilol-CR
n=6 Participants
Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.
Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication.
|
|---|---|
|
Age, Customized
Between 10 and 65 years
|
6 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male or Female
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks at highest tolerated dosePopulation: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks at highest tolerated dosePopulation: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks at highest tolerated dosePopulation: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeksPopulation: The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.
Outcome measures
Outcome data not reported
Adverse Events
Carvedilol-CR
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place