CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673240
• Other study ID #: NSS_BoNT-A
• Status: Recruiting
• Start date: March 29, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2020
• Source: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Contact: Alessio Baricich
• Phone: 03213734805
• Email: alessio.baricich[@]maggioreosp.novara.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis
• Spasticity
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Maggiore della Carità	Novara

Sponsors (4)

Lead Sponsor	Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"	Azienda Ospedaliero Universitaria Maggiore della Carita, Ipsen, SIRN

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Global Assessment of Efficacy scale)	Evaluation of treatment goal achievement by the physicians, patients and caregivers at 1 and 3 months after BoNT-A injection	1 month and 3 months after boNT-A injection
Secondary	active range of motion	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.	e, 1, 3 and 6 months or before new BoNT-A injection
Secondary	passive range of motion	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.	e, 1, 3 and 6 months or before new BoNT-A injection
Secondary	Numeric Rating Scale for pain	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).	, 1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
Secondary	EQ5-D	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.	1, 3 and 6 months after BoNT-A or before the new BoNT-A injection
Secondary	interval of time between BoNT-A reinjections	Documentation of the interval of time between reinjections will be assessed during 6-months follow up (if applicable)	3-6 months