Research

UPDATE

CLINICAL TRIAL: Adult Spasticity Registry of OnabotulinumtoxinA Treatment (ASPIRE)

About Upper Limb Spasticity (ULS)

ULS is common after a stroke or other neurological event, injury, or condition ULS is a condition in which certain muscles in your body become stiff or tight. It is caused by damage to parts of the central nervous system that control voluntary movements. When this happens, your brain sends continuous messages to muscles telling them to contract, or tighten. If you or your loved one has stiffness in the muscles of the elbow, wrist, or fingers in combination with certain conditions, it could be ULS.

Symptoms of ULS can range from mild muscle stiffness to severe, uncontrollable muscle spasms.1,2

Symptoms may include:1,2

  • Tight or stiff muscles
  • Difficulty relaxing muscles
  • Muscle spasms
  • Difficulty moving certain joints
  • Increased muscle activity in response to stretching (called stretch reflex)

Onset of ULS

There is no way to tell how long after a stroke or neurological event or condition develops that ULS might occur. This can delay the diagnosis of ULS, because you may not be seeing a specialist like a neurologist as frequently, and may be under the care of a primary care doctor instead.

If you have had a stroke, brain injury, or a specific condition such as adult cerebral palsy or multiple sclerosis, and are experiencing one or more of the symptoms associated with ULS, it is important to contact a doctor to get diagnosed and develop a treatment plan as soon as possible.

ULS can develop at any time after a major event or specific condition.

Eligibility

Ages Eligible for Study:   18 Years and older

Genders Eligible for Study:   Both

Accepts Healthy Volunteers:   No

Sampling Method:   Non-Probability Sample

Study Population

Patients with Muscle Spasticity

Criteria

Inclusion Criteria:

  • Treatment with onabotulinumtoxinA according to the decision of the physician for spasticity
  • Willingness to complete study questionnaires and answer study questions by phone or internet

Exclusion Criteria:

  • Concurrent participation in a clinical trial for spasticity
  • For more information on the clinical trial, visit http://clinicaltrials.gov/ct2/show/study/NCT01930786

    References

    1. National Institute of Neurological Disorders and Stroke, National Institutes of Health, US Department of Health and Human Services. NINDS spasticity information page. National Institute of Neurological Disorders and Stroke website. http://www.ninds.nih.gov/disorders/spasticity/spasticity.htm. Updated June 19, 2007. Accessed April 12, 2011.
    2. O’Brien CF. Treatment of spasticity with botulinum toxin. Clin J Pain. 2002;18(suppl 6):182S-190S.

    IMPORTANT SAFETY INFORMATION

    BOTOX® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

    • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
    •  
    • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

    Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

    The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.

    Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® should be discontinued.

    Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX®.

    Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX® for upper limb spasticity. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX®.

    Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.

    Tell your doctor about all your medical conditions, including if: you have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).

    Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.

    Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).

    Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

    For more information refer to the Medication Guide or talk with your doctor.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.

    ®marks owned by Allergan, Inc.  APC53GA13
    Dysport is a registered trademark of Ipsen Biopharm Limited.
    Myobloc is a registered trademark of Solstice Neurosciences, Inc.
    Xeomin is a registered trademark of Merz Pharma GmbH & Co. KGaA.