Trial Outcomes & Findings for Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344) (NCT NCT00711087)
NCT ID: NCT00711087
Last Updated: 2021-01-06
Results Overview
This outcome measure was not able to be determined due to the subject being lost to follow-up. The subject no longer returns phone calls or visits the clinic.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
2.5 years
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
ARM 2
Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
|
ARM 1
Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ARM 2
Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
|
ARM 1
Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)
Baseline characteristics by cohort
| Measure |
ARM 1
Subjects randomized to this group will receive placebo.
|
ARM 2
n=1 Participants
Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
1 years
n=7 Participants
|
1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.5 yearsPopulation: Early spinal cord injury
This outcome measure was not able to be determined due to the subject being lost to follow-up. The subject no longer returns phone calls or visits the clinic.
Outcome measures
Outcome data not reported
Adverse Events
ARM 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARM 1
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
Christopher P. Smith, MD, MBA, MSS
Baylor College of Medicine
Phone: 713-798-7498
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place