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

NCT02070302 | Completed Phase 2 Results

• 1 other identifier: 85700
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a prospective double blind controlled randomized trial of ten patients diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of medical practices in Arizona. Patients who meet inclusion criteria will be randomly distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned individuals.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (6)

• Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.

  Patients with Levine score \< 4 were included in the study. The score for this assessment can range from 11-55.

  Baseline-Week 18

• Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.

  Patients with Levine score of \< 4 were included in the study. The score for this assessment can range from 8-40

  Baseline-Week 18

• Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.

  Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.

  Baseline to Week 18

• Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at 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

  Baseline, week 6, week 12, and week 18.

• Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.

  Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.

  Baseline to Week 18

• Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.

  Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.

  Baseline-Week 18

Study Arms (2)

Botulinum Toxin Type A

ACTIVE COMPARATOR

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)

Drug: Botulinum Toxin Type A

Placebo

PLACEBO COMPARATOR

.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)

Drug: Placebo

Interventions

Botulinum Toxin Type A DRUG

40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each

Also known as: Botox

Botulinum Toxin Type A

Placebo DRUG

Placebo (Normal Saline) divided into 2 injections of .4cc each

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient history: evaluated using the Levine Scale for CTS, a self-administered questionnaire which assesses the function and severity of CTS.
• Physical Exam: including use of JAMAR pinch dynamometer to quantify initial baseline strength and confirm decreased pinch strength post injection to verify effective BOTOX® (onabotulinumtoxin A) injection.
• Electrodiagnostics (EDX): The following criteria would establish CTS through EDX namely baseline electromyogram (EMG) and nerve conduction studies (NCS): a) median nerve distal motor latency (DML) \>4.3ms or \>0.9ms above the ulnar nerve DML b) median distal sensory latency (DSL) to D-1 \>2.9ms or \>0.4ms above radial nerve D-1 DSL. c) median D-2 DSL \>3.7ms or \>0.4ms above ulnar nerve D-5 DSL (5). d) median mixed nerve palm-to-wrist latency (at 8cm) \>2.2ms or \>.3ms above ulnar mixed nerve palm-to-wrist latency (at 8cm).
• Imaging \& Measurements (NMUS): Carpal tunnel images will be obtained in a transverse plane in both a neutral relaxed position at the level of the pisiform and longitudinally during neutral and Dynamic Stress Testing (DST) by a A Sonosite M-Turbo 6-13 MHz ultrasound system or another similar system (+ 2% accuracy). Measurements: Transverse images of the CT will measure the median nerve cross sectional area (CSA) at the level of the pisiform bone. CSA measurements greater than 11 mm2 are indicative of CTS. Borderline CSA measurements would require wrist forearm ratio (WFR) measurements to be a WFR \> 1.5. Patients will need to have a CSA \>11mm2, (or WFR \>1.5) and show median nerve compression during DST of at least 30% to be included.

You may not qualify if:

• Patients with prior carpal tunnel surgery, prior history of BOTOX® (onabotulinumtoxin A) injection
• Steroid injection two months prior or three months after BOTOX® (onabotulinumtoxin A) CTS injection, median nerve denervation on needle EMG
• Major limb trauma or surgery, dysphagia
• Neuromuscular junction disorder (ie: Myasthenia gravis or Lambert-Eaton syndrome)
• Currently pregnant or breast feeding

Sponsors & Collaborators

• Benjamin Sucher: lead
• Allergan: collaborator

Study Sites (1)

Arizona Arthritis & Rheumatology

Phoenix, Arizona, 85032, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Amanda Santimaw
• Organization: Arizona Arthritis & Rheumatology Research, PLLC

amanda.santimaw@azarthritis.com

4806266653

Study Officials

• Benjamin Sucher, DO

  Arizona Arthritis & Rheumatology Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 27, 2017
• Results First Posted: September 27, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)