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StrokePhase 2EUBoSSNCT01882556

Early Use of Botulinum Toxin in Spasticity Post Stroke.

A Phase 2 study testing onabotulinumtoxinA in people with Stroke and Muscle Spasticity, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

Patients who survive a stroke are often left with an arm that cannot be used. One reason for this is that the muscles affected by the stroke become overactive. This is known as spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead to limb deformities. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Muscle Spasticity, Contracture
What is being tested?
onabotulinumtoxinA
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2012to May 2014
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Over 18 years of age.
  • Patients with stroke due to a primary cerebral haemorrhage/infarction, subarachnoid haemorrhage producing an upper motor syndrome affecting one body side which results in a hemiplegia
  • Capable of providing informed consent directly or indirectly, or, consent obtainable from next of kin or legal representative
  • No useful arm function (i.e. less than or equal to 2 on the grasp subsection of the Action Research Arm Test) at onset of spasticity

Who cannot join

  • Significant musculoskeletal conditions that affected upper limb function prior to the stroke
  • Unconscious or moribund during the screening period
  • Recovery of useful arm function (a score of 3 or more in the grasp section of the Action Research Arm Test) prior to injections
  • Patients with contraindications to electrical stimulation including active implants (e.g. cardiac assist devices), metal implants at site of stimulation, scar tissue/cancerous tissue at site of stimulation, uncontrolled epilepsy, deep vein thrombosis in limb / muscle being stimulated and pregnancy (or planned pregnancy)
  • Previous upper motor neurone syndrome or hypertonicity due to multiple sclerosis, spinal cord injury or other neurological disorder
  • Patients with a known hypersensitivity to any botulinum toxin or to any of the excipients of BOTOX® (i.e. Human serum albumin)
Show all 10Show fewer
  • Patients with myasthenia gravis or Eaton Lambert Syndrome or other neuromuscular junction or myopathic disorder
  • Patients with infection at the proposed injection site(s)
  • Patients who are pregnant or may become pregnant at the time of the proposed injections and for the duration of the study
  • Current treatment with any antispasticity agent or previous injection with BOTOX

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Sandwell and West Birmingham NHS Trust

    Birmingham, West Midlands, B18 7QH

Other trials in United Kingdom

About this study

Official title: Is it Clinically Effective to Treat Arm Flexor Spasticity, With Botulinum Toxin - Type A (BoNTA) and Physiotherapy, as Soon as Signs of Abnormal Muscle Activity Are Observed?

Patients who survive a stroke are often left with an arm that cannot be used. One reason for this is that the muscles affected by the stroke become overactive. This is known as spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead to limb deformities. For example, the wrist and fingers in the arm affected by spasticity become stiff and curl into a fist and the hand cannot be used for any functional purpose. Palm hygiene can become difficult and patients find this deformity unsightly and painful. Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this purpose. In current practice this treatment is often used as a last line of defence. Although BT can reduce the muscle overactivity, when injected using current protocols, it seems to have little impact on the recovery of function and/or treating the limb deformities and pain. If BT can be given in the early stages of a stroke, i.e. as soon as the muscle overactivity is observed, then we will be able to treat spasticity and may prevent the limb deformities and pain from developing. We may also be able to assist the recovery of arm movement in some of the patients who would otherwise not have regained this. In addition to benefiting the patient, the prevention of secondary complications by early treatment may reduce the costs of long term care to the NHS . We hope to discover if our plan of providing early treatment with BT is more effective than the current approach. If we demonstrate that the treatment is effective we will be able to introduce this new method almost immediately within the NHS through our collaboration with doctors and therapists who are actively treating patients with this condition.

Being tested
onabotulinumtoxinA, Placebo
Keywords
Early treatment of spasticity., Post stroke spasticity.
Medical subject headings
Stroke, Muscle Spasticity, Contracture

What participants receive

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

  • onabotulinumtoxinADrug

    Also called Botox, Botulinum toxin type-A

  • PlaceboDrug

Study groups in NCT01882556
Study groupRoleWhat they receive
Botulinum Toxin - Type A (onabotulinumtoxinA)ExperimentalBotulinum Toxin - Type A. One set of injections of up to 200 Units of Botox (Allergan). Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Receives: Drug: onabotulinumtoxinA
0.9% NaCl Saline InjectionPlacebo comparatorSaline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Receives: Drug: Placebo

What is being measured

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

  1. Action Research Arm Test

    Measured: 6 Months

Secondary outcomes (3)

  1. Spasticity

    In reducing focal spasticity in the arm as measured by surface electromyography (EMG) response of the wrist and elbow flexors to an externally imposed perturbation

    Measured: 6 Months

  2. Strength and Fatigue

    Strength and fatigue as measured by maximum isometric strength and the rate of force production in the wrist and elbow joints

    Measured: 6 Months

  3. Stiffness and passive range of movement.

    Range of movement and force required to produce the same with a custom built device

    Measured: 6 months

Timeline

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

  1. First posted20 Jun 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01882556
Sponsor's protocol ID
PB-PG-0808-16319
Other IDs
2010-021257-39, ISRCTN57435427
Acronym
EUBoSS
Status last verified
Nov 2014
First submitted
18 Jun 2013
Last updated
18 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Lindsay C, Simpson J, Ispoglou S, Sturman SG, Pandyan AD. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. Trials. 2014 Jan 8;15:12. doi: 10.1186/1745-6215-15-12.

    PubMed 24401159

  • Lindsay C, Humphreys I, Phillips C, Pandyan A. Estimating the cost consequence of the early use of botulinum toxin in post-stroke spasticity: Secondary analysis of a randomised controlled trial. Clin Rehabil. 2023 Mar;37(3):373-380. doi: 10.1177/02692155221133522. Epub 2022 Nov 3.

    PubMed 36325678

  • Lindsay C, Ispoglou S, Helliwell B, Hicklin D, Sturman S, Pandyan A. Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial. Clin Rehabil. 2021 Mar;35(3):399-409. doi: 10.1177/0269215520963855. Epub 2020 Oct 11.

    PubMed 33040610

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing onabotulinumtoxinA in people with Stroke and Muscle Spasticity, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.

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 4 inclusion and 10 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 18 Nov 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Action Research Arm Test (time frame: 6 Months). 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 NCT01882556, which also lists 3 linked publications.

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 18 Nov 2014.

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