Trial Outcomes & Findings for BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome (NCT NCT02070302)
NCT ID: NCT02070302
Last Updated: 2017-09-27
Results Overview
Patients with Levine score \< 4 were included in the study. The score for this assessment can range from 11-55.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline-Week 18
Results posted on
2017-09-27
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
|
Placebo
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A (Onabot)
n=5 Participants
A prospective, randomized, double blind pilot study of patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). For 5 out of 10 subjects, non-dominant hands were injected under ultrasound guidance with 40 units of Onabot (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.
|
Placebo
n=5 Participants
A prospective, randomized, double blind pilot study of 10 patients with bilateral mild to moderate CTS, diagnosed by nerve conduction studies (NCS) and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing). Non-dominant hands were injected under ultrasound guidance with 40 units of 40 units of normal saline (0.4cc) divided equally into the abductor pollicis brevis and opponens pollicis muscles. Participants were evaluated with NMUS, NCS, Levine Scale (symptom severity and functional status), and Jamar dynamometer at baseline, 6, 12, and 18 weeks.
|
Total
n=10 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 20.3 • n=7 Participants
|
56.35 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline-Week 18Population: Levine symptom severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. It ranges from 1 (no symptoms) to 5 (severe symptoms). This scale indicate how severe the CTS symptoms feel to the patient. Mean values (std deviation) are reported both Onabot and Placebo groups.
Patients with Levine score \< 4 were included in the study. The score for this assessment can range from 11-55.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=5 Participants
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
|
Placebo
n=5 Participants
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.
Visit 2-Week 6
|
0.4 Scores on a scale
Standard Deviation 6.8
|
-3.2 Scores on a scale
Standard Deviation 6.8
|
|
Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.
Visit 3-Week 12
|
-4.2 Scores on a scale
Standard Deviation 5.1
|
-9.4 Scores on a scale
Standard Deviation 8.3
|
|
Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.
Visit 4-Week 18
|
-5.4 Scores on a scale
Standard Deviation 8.7
|
-6.8 Scores on a scale
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: Baseline-Week 18Population: Levine functional severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. This scale ranges from 1 (no symptoms) to 5 (severe symptoms). The function severity scale indicate interference of the symptoms on activities of daily living. Mean values reported for each group.
Patients with Levine score of \< 4 were included in the study. The score for this assessment can range from 8-40
Outcome measures
| Measure |
Botulinum Toxin Type A
n=5 Participants
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
|
Placebo
n=5 Participants
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.
Visit 2-Week 6
|
-1.0 Scores on a scale
Standard Deviation 9.3
|
-4.4 Scores on a scale
Standard Deviation 11.9
|
|
Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.
Visit 3-Week 12
|
-3.8 Scores on a scale
Standard Deviation 4.8
|
-9.6 Scores on a scale
Standard Deviation 9.3
|
|
Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.
Visit 4-Week 18
|
-4.0 Scores on a scale
Standard Deviation 8.6
|
-12.8 Scores on a scale
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: Baseline to Week 18Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=5 Participants
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
|
Placebo
n=5 Participants
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.
Visit 2-Week 6
|
-13.0 % change
Standard Deviation 15.3
|
-20.2 % change
Standard Deviation 18.8
|
|
Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.
Visit 3-Week 12
|
-15.9 % change
Standard Deviation 19.5
|
-13.3 % change
Standard Deviation 9.4
|
|
Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.
Visit 4-Week 18
|
-12.2 % change
Standard Deviation 17.8
|
-4.7 % change
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: Baseline, week 6, week 12, and week 18.Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline
Outcome measures
| Measure |
Botulinum Toxin Type A
n=5 Participants
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
|
Placebo
n=5 Participants
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.
Visit 2-Week 6
|
-0.1 milliseconds
Standard Deviation 0.4
|
-0.1 milliseconds
Standard Deviation 0.1
|
|
Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.
Visit 3-Week 12
|
-0.3 milliseconds
Standard Deviation 0.3
|
0.0 milliseconds
Standard Deviation 0.1
|
|
Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.
Visit 4-Week 18
|
-0.3 milliseconds
Standard Deviation 0.3
|
-0.1 milliseconds
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline to Week 18Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=5 Participants
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
|
Placebo
n=5 Participants
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.
Visit 2-Week 6
|
-0.2 milliseconds
Standard Deviation 0.3
|
-0.1 milliseconds
Standard Deviation 0.1
|
|
Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.
Visit 3-Week 12
|
-0.4 milliseconds
Standard Deviation 0.5
|
-0.1 milliseconds
Standard Deviation 0.2
|
|
Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.
Visit 4-Week 18
|
-0.6 milliseconds
Standard Deviation 0.5
|
-0.1 milliseconds
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline-Week 18Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=5 Participants
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Botulinum Toxin Type A: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
|
Placebo
n=5 Participants
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.
Visit 2-Week 6
|
1.1 Pounds of Force (LBF)
Standard Deviation 1.2
|
0.5 Pounds of Force (LBF)
Standard Deviation 1.2
|
|
Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.
Visit 3-Week 12
|
1.4 Pounds of Force (LBF)
Standard Deviation 0.5
|
-0.1 Pounds of Force (LBF)
Standard Deviation 1.7
|
|
Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.
Visit 4-Week 18
|
1.4 Pounds of Force (LBF)
Standard Deviation 0.5
|
0.4 Pounds of Force (LBF)
Standard Deviation 1.2
|
Adverse Events
Botulinum Toxin Type A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Botulinum Toxin Type A
n=5 participants at risk
At 18 weeks, mean distal motor latency changes of -0.6 ms (P-value = 0.078) in the Onabot group were noted; and distal sensory latency changes of -0.3ms in the Onabot group; less slowing. Decreased mean cross-sectional area of -2.2 mm2 (P-value =0.040) in Onabot group were noted; less nerve edema. Decreased percent compression of the median nerve during stress testing was -12.6% in Onabot group. Three subjects injected with Onabot demonstrated decreases in median distal motor latencies that were nearly significant (p-value\<.1, \>.05), Two had decreases in median distal sensory latencies, and some had decreases in cross-sectional area on NMUS that were nearly significant. One Onabot subject did not show improvement or changes in median distal latencies but remained stable while the non-injected hand worsened with increasing median distal latencies.
|
Placebo
n=5 participants at risk
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo: Placebo (Normal Saline) divided into 2 injections of .4cc each
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Left Neck Pain
|
20.0%
1/5 • Number of events 1 • 18 weeks
|
0.00%
0/5 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Stiffness
|
20.0%
1/5 • Number of events 1 • 18 weeks
|
0.00%
0/5 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Right Hand Weakness
|
20.0%
1/5 • Number of events 1 • 18 weeks
|
0.00%
0/5 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • 18 weeks
|
0.00%
0/5 • 18 weeks
|
Additional Information
Amanda Santimaw
Arizona Arthritis & Rheumatology Research, PLLC
Phone: 4806266653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place