Trial Outcomes & Findings for Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain (NCT NCT02221648)
NCT ID: NCT02221648
Last Updated: 2016-07-20
Results Overview
The primary outcome measure in this protocol is the proportion of subjects that have VAS \<4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
TERMINATED
PHASE2
43 participants
6 weeks
2016-07-20
Participant Flow
Due to relocation of PI, study was terminated with 43 enrollments(total).
Participant milestones
| Measure |
Placebo
Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
|
ArbobotulinumtoxinA Treatment
Subjects will receive intervention injections with the study drug abobotulinumtoxinA.
AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
|
ArbobotulinumtoxinA Treatment
Subjects will receive intervention injections with the study drug abobotulinumtoxinA.
AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
Subjects will be randomization to receive injections with either the study drug (incobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
|
AbobotulinumtoxinA Treatment
n=18 Participants
All subjects will receive intervention injections with the study drug abobotulinumtoxinA.
|
Total
n=37 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
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe primary outcome measure in this protocol is the proportion of subjects that have VAS \<4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
Outcome measures
| Measure |
Placebo
n=19 Participants
Subjects will be randomized to receive injections with saline.
|
AbobotulinumtoxinA Treatment
n=18 Participants
All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
|
|---|---|---|
|
Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 6 weeksThe PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7) This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment
Outcome measures
| Measure |
Placebo
n=19 Participants
Subjects will be randomized to receive injections with saline.
|
AbobotulinumtoxinA Treatment
n=18 Participants
All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
|
|---|---|---|
|
Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)
|
2 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 6 weeksThe Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.
Outcome measures
| Measure |
Placebo
n=19 Participants
Subjects will be randomized to receive injections with saline.
|
AbobotulinumtoxinA Treatment
n=18 Participants
All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
|
|---|---|---|
|
Number of Subjects Showing Improvement on Quality of Life Scale for Pain
|
4 participants
|
10 participants
|
Adverse Events
Placebo
ArbobotulinumtoxinA Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bahman Jabbari M.D, , Professor of Neurology
Yale University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place