A Phase 2 interventional study of onabotulinumtoxinA and Placebo in Stroke, Muscle Spasticity and Contracture, sponsored by Sandwell & West Birmingham Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-18.
Sponsored by Sandwell & West Birmingham Hospitals NHS Trust · Phase 2, Interventional, and Treatment
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 120 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Sandwell & West Birmingham Hospitals NHS Trust is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Botulinum 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.
Drug: onabotulinumtoxinA
Saline - Injected to Biceps, Brachialis, Flexor Dig Superficialis, Flexor Dig Profundus, Flexor Carpi Radialis and Flexor Carpi Ulnaris.
Drug: Placebo
Also known as: Botox, Botulinum toxin type-A
Action Research Arm Test
Time frame: 6 Months
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
Time frame: 6 Months
Strength and Fatigue
Strength and fatigue as measured by maximum isometric strength and the rate of force production in the wrist and elbow joints
Time frame: 6 Months
Stiffness and passive range of movement.
Range of movement and force required to produce the same with a custom built device
Time frame: 6 months
Quality of Life
EuroQol EQ-5D
Time frame: 6 Months
Care Giver Strain Index
Time frame: 6 Months
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Sandwell & West Birmingham Hospitals NHS Trust