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BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02070302
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Benjamin Sucher, Arizona Arthritis & Rheumatology Research, PLLC.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Carpal Tunnel Syndrome
Interventions Drug: Botulinum Toxin Type A
Drug: Placebo
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description

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

.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

Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Botulinum Toxin Type A (Onabot) Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
10 patients with bilateral CTS, diagnosed by nerve conduction studies and NMUS (with crosssectional area measurements; and percentage of nerve compression measured during mechanical stress testing), divided into control and Onabot groups. Non-dominant hands were injected under ultrasound guidance with 40 units (0.4 cc) of Onabot or normal saline.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
3
  60.0%
6
  60.0%
>=65 years
2
  40.0%
2
  40.0%
4
  40.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
60.4  (17.9) 52.3  (20.3) 56.35  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
1
  20.0%
3
  60.0%
4
  40.0%
Male
4
  80.0%
2
  40.0%
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.
Hide Description Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55.
Time Frame Baseline-Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:

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

.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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Visit 2-Week 6 0.4  (6.8) -3.2  (6.8)
Visit 3-Week 12 -4.2  (5.1) -9.4  (8.3)
Visit 4-Week 18 -5.4  (8.7) -6.8  (6.8)
2.Primary Outcome
Title Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.
Hide Description Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40
Time Frame Baseline-Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:

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

.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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Visit 2-Week 6 -1.0  (9.3) -4.4  (11.9)
Visit 3-Week 12 -3.8  (4.8) -9.6  (9.3)
Visit 4-Week 18 -4.0  (8.6) -12.8  (6.1)
3.Primary Outcome
Title Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.
Hide Description Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.
Time Frame Baseline to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:

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

.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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: % change
Visit 2-Week 6 -13.0  (15.3) -20.2  (18.8)
Visit 3-Week 12 -15.9  (19.5) -13.3  (9.4)
Visit 4-Week 18 -12.2  (17.8) -4.7  (14.0)
4.Primary Outcome
Title Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.
Hide Description Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline
Time Frame Baseline, week 6, week 12, and week 18.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:

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

.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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: milliseconds
Visit 2-Week 6 -0.1  (0.4) -0.1  (0.1)
Visit 3-Week 12 -0.3  (0.3) 0.0  (0.1)
Visit 4-Week 18 -0.3  (0.3) -0.1  (0.3)
5.Primary Outcome
Title Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.
Hide Description Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.
Time Frame Baseline to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:

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

.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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: milliseconds
Visit 2-Week 6 -0.2  (0.3) -0.1  (0.1)
Visit 3-Week 12 -0.4  (0.5) -0.1  (0.2)
Visit 4-Week 18 -0.6  (0.5) -0.1  (0.3)
6.Primary Outcome
Title Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.
Hide Description Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.
Time Frame Baseline-Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:

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

.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 Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: Pounds of Force (LBF)
Visit 2-Week 6 1.1  (1.2) 0.5  (1.2)
Visit 3-Week 12 1.4  (0.5) -0.1  (1.7)
Visit 4-Week 18 1.4  (0.5) 0.4  (1.2)
Time Frame 18 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description 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.

.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

All-Cause Mortality
Botulinum Toxin Type A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Botulinum Toxin Type A Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botulinum Toxin Type A Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      0/5 (0.00%)    
Musculoskeletal and connective tissue disorders     
Left Neck Pain * [1]  1/5 (20.00%)  1 0/5 (0.00%)  0
Neck Stiffness * [1]  1/5 (20.00%)  1 0/5 (0.00%)  0
Right Hand Weakness * [2]  1/5 (20.00%)  1 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash * [3]  1/5 (20.00%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Unrelated to the study
[2]
Related to the study.
[3]
Rash on Left Groin Area. Not related to the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amanda Santimaw
Organization: Arizona Arthritis & Rheumatology Research, PLLC
Phone: 4806266653
EMail: amanda.santimaw@azarthritis.com
Layout table for additonal information
Responsible Party: Benjamin Sucher, Arizona Arthritis & Rheumatology Research, PLLC.
ClinicalTrials.gov Identifier: NCT02070302    
Other Study ID Numbers: 85700
85700 ( Other Grant/Funding Number: Allergan Sales. LLC )
First Submitted: February 20, 2014
First Posted: February 25, 2014
Results First Submitted: March 10, 2017
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017