Study of Botulinum Toxin and Recovery of Hand Function After Stroke

NCT01422161 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 10-01126
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).

Conditions

Stroke With Hemiparesis

Keywords

Rehabilitation; Fingers; Grasp; Hand; Strength; Brain Infraction; Pathology; Physiopathology; Functional Laterality; Neuronal Plasticity; Psychomotor Performance; Biomechanics; Touch; Weight-Bearing

Outcome Measures

Primary Outcomes (2)

• Time Taken to Form a Stable Grasp Pre-Treatment

  Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for: * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.

  Day 1

• Time Taken to Form a Stable Grasp Post Treatment

  * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.

  90 Days

Secondary Outcomes (4)

• Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale

  Pre-Treatment, Day 90

• Disability Measured by Modified Rankin Scale Score Post-Treatment

  90 Days

• Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment

  1 Day and 90 Days

• Disability Measured by Modified Rankin Scale Score Pre-Treatment

  Pre-Treatment

Study Arms (2)

Botulinum Toxin commonly known as BOTOX®

EXPERIMENTAL

Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.

Drug: Botulinum Toxin commonly known as BOTOX®

Placebo

PLACEBO COMPARATOR

Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.

Drug: Placebo

Interventions

Botulinum Toxin commonly known as BOTOX® DRUG

A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. There will be 1 treatment cycle during the 9 week study.

Also known as: BOTOX®, Saline

Botulinum Toxin commonly known as BOTOX®

Placebo DRUG

The control group will receive a placebo injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to follow study instructions and likely to complete all required visits
• Ability to comply with the therapy protocol as assessed by the investigator
• months post first-time unilateral stroke with right or left hemiparesis and complaints of unilateral hand dysfunction
• Must have ability to grasp and lift the test object
• Subjects must have upper extremity motor impairment

You may not qualify if:

• Known allergy or sensitivity to botulinum toxin type A (BOTOX).
• Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
• Concurrent participation in another investigational drug or device study or participation in another Botulinum toxin study in the 6 months prior to study.
• Treatment with botulinum toxin of any serotype in the 3 months prior to study enrollment
• Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.
• Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition.
• Infection or skin disorder at an anticipated injection site.
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
• History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
• Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
• Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
• Current treatment with intrathecal baclofen.

Sponsors & Collaborators

• NYU Langone Health: lead
• Allergan: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Sodium Chloride

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Preeti Raghavan, MD
• Organization: New York University School of Medicine

raghap01@nyumc.org

212 598 6206

Study Officials

• Preeti Raghavan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: April 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 20, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-06

Locations

US (1)