Clinical trial • Phase IV • Neurology

CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Severe multifocal spasticity due to acquired brain damage

Phase IV trial of CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Severe multifocal spasticity due to acquired brain dama…

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Severe multifocal spasticity due to acquired brain damage
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
20-09-2024
First CTIS Authorization Date
02-10-2024

Trial design

None/Not specified-controlled Phase IV trial in Spain.

Comparator
None/Not specified
Target Sample Size
30

Eligibility

Recruits 30 No vulnerable populations selected. Adults only ("Patients older than 18 years"). Informed consent required: "That they agree to participate in the study and sign the informed consent"..

Pregnancy Exclusion
Pregnant patients or under lactating period.
Vulnerable Population
No vulnerable populations selected. Adults only ("Patients older than 18 years"). Informed consent required: "That they agree to participate in the study and sign the informed consent".

Inclusion criteria

  • {"criterion_text":"- Patients older than 18 years\n- with a diagnosis of severe multifocal spasticity of the upper and lower limbs due to acquired brain damage\n- Who need treatment with IncobotulinumtoxinA at a dose equal to or greater than 800U\n- That they agree to participate in the study and sign the informed consent\n- With pain assessment data (VAS scale), muscle tone (Asworth scale), and Barthel scale during the follow-up evaluation.\n- No contraindications for treatment with botulinum toxin"}

Exclusion criteria

  • {"criterion_text":"- Patients with severe systemic diseases and active infection\n- Pregnant patients or under lactating period."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Asworth scale at 6 weeks of treatment","definition_or_measurement_approach":"Assessment using the Asworth (Ashworth) scale at 6 weeks after treatment (timepoint specified as 6 weeks)."}

Secondary endpoints

  • {"endpoint_text":"- Pain: Variation on the VAS scale (0-10) at 6 and 12 weeks of treatment\n- Effect on the Asworth scale at 12 weeks from drug infiltration\n- Barthel scale at 6 and 12 weeks after injection\n- Satisfaction with treatment\n- Assess the safety and tolerability of the treatment","definition_or_measurement_approach":"Pain: measured by VAS (0-10) at 6 and 12 weeks; Effect on Asworth: Asworth scale at 12 weeks; Barthel: Barthel scale at 6 and 12 weeks; Satisfaction with treatment: not further defined in record; Safety and tolerability: not further specified in record."}

Recruitment

Planned Sample Size
30
Recruitment Window Months
24
Consent Approach
Informed consent required from participants: "That they agree to participate in the study and sign the informed consent". Subject information and informed consent form for adults is listed in documents (L1_SIS and ICF adults).

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Spain

Earliest CTIS Part Ii Submission Date
01-10-2024
Latest Decision Or Authorization Date
02-10-2024
Processing Time Days
1
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Hospital Doctor Moliner
Department Name
Rehabilitación
Principal Investigator Name
Nuria Gutierrez
Principal Investigator Email
gutierrez_nur@gva.es
Contact Person Name
Nuria Gutierrez
Contact Person Email
gutierrez_nur@gva.es
Number Of Participants
30

Sponsor

Primary sponsor

Full Name
Dra. Nuria Gutierrez Dubón
Organisation Type
Health care
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
XEOMIN 50 unidades polvo para solución inyectable
Active Substance
CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
Modality
Peptide/protein/enzyme
Routes Of Administration
SOLUTION FOR INJECTION
Route
Solution for injection
Authorisation Status
Authorised (marketing authorisation number 74067; euMpNumber PRD10941714)
Dose Levels
Up to 800 IU (maxDailyDoseAmount/maxTotalDoseAmount 800 IU)
Maximum Dose
800 IU
Investigational Product Name
BOTULINUM TOXIN TYPE A
Active Substance
BOTULINUM TOXIN TYPE A
Modality
Peptide/protein/enzyme
Routes Of Administration
SOLUTION FOR INJECTION
Route
Solution for injection
Authorisation Status
No marketing authorisation number provided
Dose Levels
Up to 800 IU (maxDailyDoseAmount/maxTotalDoseAmount 800 IU)
Maximum Dose
800 IU

Related trials

Other published trials that may interest you.