Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03367429
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle tone) in central neurological disease, evidence-based guidance on dosing, dilution, and injection technique is limited. The wide-spread use of BT in spasticity management, expense of these agents, and detrimental impact from movement into non-injected muscles mandates a better understanding of BT movement within muscles. A proof-of-concept paper written by investigators at Weill Cornell Medicine introduced a non-invasive MRI approach with "voxel thresholds" that was able to detect intramuscular effects of BT at 2 and 3 months post-injection of BT. The purpose of the current set of studies is to refine this MRI technique to better visualize the movement of botulinum toxin through muscle. In addition, the investigators plan to explore, using the imaging technique, how spastic muscle and differing dilutions affect BT movement in an effort to support the development of better research techniques to study toxin movement in human muscle.

Condition or disease Intervention/treatment Phase
Stroke Muscle Spasticity Drug: Botox Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Please see study design for details regarding how design for this experiment will be determined.

If the within-subject design is used, N=15 and subjects will be randomized 1:1 to receive the standard injection to either the LGM or MGM. The experimental injection will be delivered to the muscle not receiving the standard injection.

If the between-subject design must be used, N=25 and subjects will be randomized 2:3 to receive either the experimental or standard injection to the spastic LGM.

Please note the following:

Standard Injection: 25 units of onobotulinumtoxinA (Botox®) diluted in 0.25cc of saline.

Experimental Injection: 25 units of onobutilinumtoxinA (Botox®) diluted in 0.50cc of saline.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Exp 2 & 3 - Arm 1

If within-subject design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM and one standard BT injection of of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic MGM.

If between-subjects design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM.

Drug: Botox
Please see arm descriptions for intervention description.

Experimental: Exp 2 & 3 - Arm 2

If within-subject study design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM and one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic MGM.

If between-subjects design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM.

Drug: Botox
Please see arm descriptions for intervention description.




Primary Outcome Measures :
  1. Botulinum Toxin Muscle Effect (BTME) Volume of Abnormal Voxels per MRI Slice in Muscles after Research Injections [ Time Frame: At MRI 2, 2 Months after Research Injections ]
    BTME volume is calculated by counting the number of abnormal voxels (each voxel volume is .0015 cc) on MRI2, which have a relaxation time greater than or equal to 3 standard deviations above the baseline mean for a subject and their muscle found on their baseline MRI.


Secondary Outcome Measures :
  1. Change in Botulinum Toxin Muscle Effect (BTME) Volume of Abnormal Voxels per MRI Slice in Muscles after Clinical Injections [ Time Frame: At MRI 3, 2 Months after Clinical Injections ]
    Change in volume of BTME in injected muscle after clinical injection recorded on MRI3 compared to BTME volume on MRI 2.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female aged 30-70
  • Diagnosis of any stroke (ischemic or hemorrhagic, first occurrence or recurrent)
  • Clinically significant lower extremity spasticity as assessed by PI that would benefit from BT treatment
  • Ambulatory with or without device and without assistance at household or greater level
  • Indication to inject gastrocnemius muscle (any combination of spastic lower extremity muscle injections are acceptable)
  • Goal of treatment may include improvement of gait, ankle range of motion, ankle foot orthosis fit, heel strike, ankle position in stance3 phase, decreased clonus, or relief from painful muscle spasms
  • Naïve to BT of any serotype in any lower extremity muscle
  • Naïve to phenol or alcohol treatment in any lower extremity muscle

Exclusion Criteria:

  • History of concomitant neurological disease (central or peripheral) other than stroke
  • Contraindication to intramuscular injection of BT
  • Medically unstable as determined by PI
  • On an oral anti-spasticity agent
  • Have an intrathecal baclofen pump
  • Contraindication for MRI (Subjects with MRI-compatible hip replacements may participate, but not those with total knee replacements due to artifact)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367429


Contacts
Layout table for location contacts
Contact: Ryan J Lowder 212-746-1509 ryl2004@med.cornell.edu

Locations
Layout table for location information
United States, New York
NewYork Presbyterian Hospital - Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Ryan Lowder, BA    212-746-1509    ryl2004@med.cornell.edu   
Contact: Erica Kwong, BA    212-746-1857    egk2001@med.cornell.edu   
Principal Investigator: Michael O'Dell, M.D.         
Sub-Investigator: Jonathan Dyke, Ph.D.         
Sub-Investigator: Douglas Ballon, Ph.D.         
Sub-Investigator: Ryan Lowder, B.A.         
Sub-Investigator: Erica Kwong, B.A.         
Sub-Investigator: Ruchi Patel, MA         
Sponsors and Collaborators
Weill Medical College of Cornell University
Allergan
Investigators
Layout table for investigator information
Principal Investigator: Michael O'Dell, M.D. Weill Cornell Medicine

Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03367429     History of Changes
Other Study ID Numbers: 1708018456
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Weill Medical College of Cornell University:
stroke
spasticity

Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs