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CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY

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: NCT04673240
Recruitment Status : Unknown
Verified December 2020 by Alessio Baricich, Università degli Studi del Piemonte Orientale "Amedeo Avogadro".
Recruitment status was:  Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborators:
Ipsen
Azienda Ospedaliero Universitaria Maggiore della Carita
SIRN
Information provided by (Responsible Party):
Alessio Baricich, Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Study Description
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Brief Summary:

Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex.

The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity.

Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015).

In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016).

However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS).

Interestingly, spasticity is a major concern for the rehabilitation of these patients.

The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.


Condition or disease Intervention/treatment
Spasticity Brain Injuries Spinal Cord Injuries Multiple Sclerosis Drug: Botulinum toxin type A injection

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN THE TREATMENT OF SPASTICITY AFTER TRAUMATIC BRAIN INJURY, SPINAL CORD INJURY OR IN MULTIPLE SCLEROSIS PATIENTS: AN OBSERVATIONAL STUDY
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Botulinum toxin type A injection

    Adult patients with spasticity due to traumatic brain injury, spinal cord injury, or MS, treated with Botulinum Toxin type A.

    As this is a non-interventional study, no diagnostic, therapeutic, or experimental intervention is involved. Subjects will receive clinical assessments, medications, and treatments solely as determined by their study physician.


Outcome Measures
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Primary Outcome Measures :
  1. Modified Ashworth Scale (MAS) [ Time Frame: 1 month ]
    Percentage of patients with at least 1 point reduction of MAS in any treated muscle, 1 month after BoNT-A injection injection of Botulinum toxin A (responders)


Secondary Outcome Measures :
  1. Global Assessment of Efficacy scale) [ Time Frame: 1 month and 3 months after boNT-A injection ]
    Evaluation of treatment goal achievement by the physicians, patients and caregivers at 1 and 3 months after BoNT-A injection

  2. active range of motion [ Time Frame: e, 1, 3 and 6 months or before new BoNT-A injection ]
    Documentation of active range of motion (a-ROM) for the treated joints in the overall study population at baseline, 1, 3 and 6 months or before new BoNT-A injection using a handheld goniometer.

  3. passive range of motion [ Time Frame: e, 1, 3 and 6 months or before new BoNT-A injection ]
    Documentation of passive range of motion (p-ROM) for the treated joints in the overall study population at baseline, 1, 3 and 6 months or before new BoNT-A injection using a handheld goniometer.

  4. Numeric Rating Scale for pain [ Time Frame: , 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection ]
    Pain will be assessed in the overall study population at baseline, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection using Numeric Rating Scale (pain).

  5. EQ5-D [ Time Frame: 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection ]
    Quality of life will be assessed in the overall study population at baseline, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection using EQ5-D questionnaire.

  6. interval of time between BoNT-A reinjections [ Time Frame: 3-6 months ]
    Documentation of the interval of time between reinjections will be assessed during 6-months follow up (if applicable)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with spasticity as a consequence of traumatic brain injury, spinal cord injury or MS, treated with Botulinum Toxin type A.
Criteria

Inclusion Criteria:

  • Age >18 years
  • Spasticity as a consequence of traumatic brain injury, spinal cord injury or MS (documented by clinical records)
  • Muscle tone graded at least 1+ on the modified Ashworth scale in the relevant joints of the affected limb(s), which requires medical intervention
  • BoNT naïve or pre-treated with any BoNT product. If previously treated with any BoNT, at least a 4 months interval between last injection and inclusion

Exclusion Criteria:

  • Presence of fixed contractures or bony deformities in the affected limb
  • Changes in any oral antispastic medications or specific physiotherapy regimen <4m before study entry or during the study.
  • Other neurological or orthopaedic conditions involving the affected limbs.
  • Sensitivity to BoNT-A or to its excipients
  • Other contraindications as given in the local SmPC for BoNT-A
Contacts and Locations
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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): NCT04673240


Contacts
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Contact: Alessio Baricich 03213734805 alessio.baricich@maggioreosp.novara.it
Contact: Roberta Carozzi 0321 3734805

Locations
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Italy
Azienda Ospedaliero Universitaria Maggiore della Carità Recruiting
Novara, Italy, 28100
Contact: Alessio Baricich, MDPhD    03213734805    alessio.baricich@maggioreosp.novara.it   
Sponsors and Collaborators
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Ipsen
Azienda Ospedaliero Universitaria Maggiore della Carita
SIRN
Investigators
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Study Chair: Alessio Baricich Università del Piemonte orientale "Amedeo Avogadro"
More Information
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Responsible Party: Alessio Baricich, MD PhD, Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
ClinicalTrials.gov Identifier: NCT04673240    
Other Study ID Numbers: NSS_BoNT-A
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Muscle Spasticity
Multiple Sclerosis
Brain Injuries
Spinal Cord Injuries
Sclerosis
Wounds and Injuries
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents