Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity

Muscle Spasticity Clinical Trial

Official title:

A Prospective, Non-interventional, Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387074
• Other study ID #: MAF/AGN/NS/SPA/018
• Status: Completed
• Phase: N/A
• First received: June 30, 2011
• Last updated: December 13, 2013
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Federal Institute for Drugs and Medicinal Devices (BfArM)
• Study type: Observational

Clinical Trial Summary

This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with upper limb spasticity following a stroke

• Eligible to receive botulinum toxin Type A

• No previous botulinum toxin Type A therapy

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

Biological:
• botulinum toxin Type A
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline	The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Baseline	No
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24	The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Week 24	No
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline	The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Baseline	No
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24	The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Week 24	No
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline	The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Baseline	No
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24	The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Week 24	No
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline	The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Baseline	No
Primary	Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24	The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.	Week 24	No