CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY

NCT04673240 | Unknown

• 1 other identifier: NSS_BoNT-A
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity; Brain Injuries; Spinal Cord Injuries; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale (MAS)

  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)

  1 month

Secondary Outcomes (6)

• Global Assessment of Efficacy scale)

  1 month and 3 months after boNT-A injection

• active range of motion

  e, 1, 3 and 6 months or before new BoNT-A injection

• passive range of motion

  e, 1, 3 and 6 months or before new BoNT-A injection

• Numeric Rating Scale for pain

  , 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection

• EQ5-D

  1, 3 and 6 months after BoNT-A or before the new BoNT-A injection

Interventions

Botulinum toxin type A injection DRUG

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi del Piemonte Orientale Amedeo Avogadro: lead
• Ipsen: collaborator
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator
• SIRN: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (1)

• Baricich A, Battaglia M, Cuneo D, Cosenza L, Millevolte M, Cosma M, Filippetti M, Dalise S, Azzollini V, Chisari C, Spina S, Cinone N, Scotti L, Invernizzi M, Paolucci S, Picelli A, Santamato A. Clinical efficacy of botulinum toxin type A in patients with traumatic brain injury, spinal cord injury, or multiple sclerosis: An observational longitudinal study. Front Neurol. 2023 Apr 6;14:1133390. doi: 10.3389/fneur.2023.1133390. eCollection 2023.

  PMID: 37090974 DERIVED

MeSH Terms

Conditions

Muscle Spasticity; Brain Injuries; Spinal Cord Injuries; Multiple Sclerosis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

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

Study Officials

• Alessio Baricich

  Università del Piemonte orientale "Amedeo Avogadro"

  STUDY CHAIR

Central Study Contacts

Alessio Baricich

CONTACT

03213734805; alessio.baricich@maggioreosp.novara.it

Roberta Carozzi

CONTACT

0321 3734805

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 17, 2020
• Study Start: March 29, 2019
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

IT (1)