Muscle SpasticityNCT01387074

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

An observational study of Muscle Spasticity, run by Allergan at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Muscle Spasticity
What is being tested?: botulinum toxin Type A
How many people: 108 participants
Where: 1 siteGermany
Study dates: Jun 2011to Jan 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients with upper limb spasticity following stroke who are eligible to receive botulinum toxin Type A treatment

Who may be able to join

Adult patients with upper limb spasticity following a stroke
Eligible to receive botulinum toxin Type A
No previous botulinum toxin Type A therapy

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Itzehoe, Schleswig-Holstein

Other trials in Germany

About this study

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

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.

Conditions: Muscle Spasticity
Being tested: botulinum toxin Type A
Medical subject headings: Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

botulinum toxin Type ABiological
Also called BOTOX®
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.

Study groups in NCT01387074
Study group	Role	What they receive
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. Receives: Biological: botulinum toxin Type A

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline
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.
Measured: Week 24
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.
Measured: Baseline
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.
Measured: Week 24
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.
Measured: Baseline
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.
Measured: Week 24
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.
Measured: Baseline
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.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jan 2013

First posted4 Jul 2011 (estimated)
Study startJun 2011
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Muscle SpasticityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01387074
Sponsor's protocol ID: MAF/AGN/NS/SPA/018
Status last verified: Dec 2013
First submitted: 30 Jun 2011
Last updated: 3 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke

All Muscle Spasticity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Non-interventional, Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
ClinicalTrials.gov ID: NCT01387074
Acronym / sponsor ID: MAF/AGN/NS/SPA/018
Conditions: Muscle Spasticity
Study type: Observational
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 4 Jul 2011 (estimated)
Results: Posted 3 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
botulinum toxin Type A	–	Biological: botulinum toxin Type ABotulinum 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients with upper limb spasticity following stroke who are eligible to receive botulinum toxin Type A treatment

Key inclusion criteria (3 listed)

Adult patients with upper limb spasticity following a stroke
Eligible to receive botulinum toxin Type A
No previous botulinum toxin Type A therapy

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
botulinum toxin Type AAlso: BOTOX®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.	Biological	botulinum toxin Type A

Primary outcome

Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
Time frame: 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.
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
Time frame: 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.
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
Time frame: 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.
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
Time frame: 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.
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
Time frame: 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.
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
Time frame: 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.
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
Time frame: 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.
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
Time frame: 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.

Results and safety

Results posted to the registry on 3 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botulinum Toxin Type A	108	100

Primary outcome: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline

Time frame: Baseline. Number. Unit: Participants

Measure	Botulinum Toxin Type A n = 101
0=No Increase	2
1=Slight Increase	6
1+=Slight Increase	18
2=Marked Increase	39
3=Considerable Increase	30
4=Affected part rigid	6

Population analysed: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.

Primary outcome: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24

Time frame: Week 24. Number. Unit: Participants

Measure	Botulinum Toxin Type A n = 89
0=No Increase	2
1=Slight Increase	26
1+=Slight Increase	43
2=Marked Increase	12
3=Considerable Increase	5
4=Affected part rigid	1

Population analysed: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.

Primary outcome: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline

Time frame: Baseline. Number. Unit: Participants

Measure	Botulinum Toxin Type A n = 101
0=No Increase	3
1=Slight Increase	9
1+=Slight Increase	16
2=Marked Increase	29
3=Considerable Increase	35
4=Affected part rigid	9

Population analysed: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.

Primary outcome: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24

Time frame: Week 24. Number. Unit: Participants

Measure	Botulinum Toxin Type A n = 89
0=No Increase	5
1=Slight Increase	31
1+=Slight Increase	31
2=Marked Increase	15
3=Considerable Increase	6
4=Affected part rigid	1

Population analysed: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botulinum Toxin Type A	1 of 108 (0.9%)	0 of 108 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Muscle Spasticity

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Spasticity, run by Allergan at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01387074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2014.