Muscle SpasticityASPIRENCT01930786
An Adult Spasticity Registry of OnabotulinumtoxinA Treatment
An observational study of Muscle Spasticity, run by Allergan at 55 sites in 7 countries.
Trial summary
This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician. 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?
- onabotulinumtoxinA
- How many people
- 744 participants
- Where
- 55 sitesin 7 countries
- Study dates
- 16 Oct 2013to 9 Oct 2017
- Phase
- Observational
- 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
Study population: Patients with Muscle Spasticity
Who may be able to join
- 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
Who cannot join
- Concurrent participation in a clinical trial for spasticity
Trial locations and contacts
55 sites in 7 countries.
55 sites in 7 countries
United States26 sites
Kernan Hospital
Baltimore, Maryland, 21207
Medical University of South Carolina
Charleston, South Carolina, 29425
The Curators of the University of Missouri on behalf of University of Missouri Health Care
Columbia, Missouri, 65212
Dayton Center for Neurological Disorders
Dayton, Ohio, 45459
Design Neuroscience Center
Doral, Florida, 33172
Albert Einstein Healthcare Network, Moss Rehabilitation Hospital
Elkins Park, Pennsylvania, 19027
Seacoast Physiatry
Exeter, New Hampshire, 03833
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334
CentraState Medical Center
Freehold, New Jersey, 07728
Guilford Neurologic Associates
Greensboro, North Carolina, 27405
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial Hermann Hospital
Houston, Texas, 77030
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
Loma Linda University School Of Medicine
Loma Linda, California, 92350
Center for Neurological Disorders, S.C.
Milwaukee, Wisconsin, 53215
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
MS Center of California
Newport Beach, California, 92663
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32514
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213
Gil, Ramon A.
Port Charlotte, Florida, 33952
Metrolina Neurological Assoc., PA
Rock Hill, South Carolina, 29732
Sutter Health General Hospital
Sacramento, California, 95816
Swedish Neuroscience Institute
Seattle, Washington, 98122
MedTechnical, PLLC
Silver Spring, Maryland, 20910
Scott & White Memorial Hospital
Temple, Texas, 76508
Spain7 sites
Hospital del Mar
Barcelona, 08003
Vall d'Hebron Institut de Recerca-VHIR
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Complejo Hospitalario de Pontevedra
Pontevedra, 36071
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital de Conxo (Santiago de Compostela) GALICIA
Santiago de Compestela, Pontevedra, 15706
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, 08221
Germany6 sites
Parkinson Klinik Wolfach GmbH & Co KG
Baden Wuerttemberg, 77709
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitaetsklinikum Jena
Jena, Thuringia, 07740
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, 04103
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149
France5 sites
Hôpital Morvan
Brest, Finistere, 239609
CHU de Grenoble - Hôpital Sud
Échirolles, Isere, 38434
Hopital Saint Philibert - GHICL Lille
Lomme, Nord, 59160
Centre Hospitalier de Pau
Pau, Pyrenees Atlantiques, 64046
Pôle Saint Helier
Rennes, Ille Et Vilaine, 35043
United Kingdom5 sites
Kent and Canterbury Hospital
Kent, Kent, CT1 3NG
The Walton Centre
Liverpool, Merseyside, L9 7LI
The National Hospital for Neurology & Neurosurgery
London, Greater London, WC1N 3BG
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, NG5 1PB
Birch Hill Hospital
Rochdale, Greater Manchester, OL12 9QB
Italy4 sites
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
Ospedale San Raffaele
Milan, 20132
Azienda Ospedaliero - Universitaria Maggiore delle Carità
Novara, 28100
Policlinico Universitario Agostino Gemelli
Roma, 00168
Taiwan2 sites
Taipei Medical University Hospital
Taipei, 110
Chang Gung Memorial Hospital, Linkou
Taoyuan County, 333
About this study
Official title: ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment
This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.
- Conditions
- Muscle Spasticity
- Being tested
- onabotulinumtoxinA
- Medical subject headings
- Muscle Spasticity
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
onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.
| Study group | Role | What they receive |
|---|---|---|
| onabotulinumtoxinA | onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician. Receives: Drug: onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Reporting Satisfaction with Treatment
Measured: 5 Weeks
Percentage of Health Care Providers Reporting Satisfaction with Treatment
Measured: 12 Weeks
Secondary outcomes (3)
Physical Functioning on a 5-Point Scale
Measured: 5 Weeks
Severity of Pain on an 11-Point Scale
Measured: 5 Weeks
Disability Assessment on a 4-Point Scale
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study start16 Oct 2013
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aleks Zuzek, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930786
- Sponsor's protocol ID
- GMA-BTX-SP-12-001
- Acronym
- ASPIRE
- Status last verified
- Feb 2019
- First submitted
- 26 Aug 2013
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Wissel J, List C, Schwartz M, Nelson M, Musacchio T, Duarte E. Relief of pain associated with spasticity in adult patients after treatment with onabotulinumtoxinA: Post hoc observational results from the ASPIRE study. PM R. 2026 Apr;18(4):410-425. doi: 10.1002/pmrj.70013. Epub 2025 Sep 30.
PubMed 41025675Bavikatte G, Francisco GE, Jost WH, Baricich A, Duarte E, Tang SFT, Schwartz M, Nelson M, Musacchio T, Esquenazi A. Pain, disability, and quality of life in participants after concurrent onabotulinumtoxinA treatment of upper and lower limb spasticity: Observational results from the ASPIRE study. PM R. 2024 Nov;16(11):1175-1189. doi: 10.1002/pmrj.13195. Epub 2024 May 30.
PubMed 38813838Bavikatte G, Esquenazi A, Dimyan MA, Dashtipour K, Feng W, Mayadev A, Fanning K, Musacchio T, Zuzek A, Francisco GE. Safety and Real-World Dosing of OnabotulinumtoxinA for the Treatment of Adult Spasticity: Post Hoc Analysis of the Adult Spasticity International Registry Study. Am J Phys Med Rehabil. 2024 Jul 1;103(7):580-587. doi: 10.1097/PHM.0000000000002410. Epub 2024 Jan 8.
PubMed 38206635Esquenazi A, Francisco GE, Feng W, Baricich A, Gallien P, Fanning K, Zuzek A, Bandari DS, Wittenberg GF. Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2172-2184.e6. doi: 10.1016/j.apmr.2021.06.008. Epub 2021 Jul 7.
PubMed 34245684Esquenazi A, Bavikatte G, Bandari DS, Jost WH, Munin MC, Tang SFT, Largent J, Adams AM, Zuzek A, Francisco GE. Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity. PM R. 2021 Oct;13(10):1079-1093. doi: 10.1002/pmrj.12517. Epub 2021 Jan 11.
PubMed 33151636Francisco GE, Jost WH, Bavikatte G, Bandari DS, Tang SFT, Munin MC, Largent J, Adams AM, Zuzek A, Esquenazi A. Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study. PM R. 2020 Nov;12(11):1120-1133. doi: 10.1002/pmrj.12328. Epub 2020 Feb 27.
PubMed 31953896
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment
- ClinicalTrials.gov ID
- NCT01930786
- Acronym / sponsor ID
- ASPIRE / GMA-BTX-SP-12-001
- Conditions
- Muscle Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
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 registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| onabotulinumtoxinA | – | Drug: onabotulinumtoxinAonabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Muscle Spasticity
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Concurrent participation in a clinical trial for spasticity
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 |
|---|---|---|
| onabotulinumtoxinAAlso: BOTOX®, botulinum toxin Type AonabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician. | Drug | onabotulinumtoxinA |
Primary outcome
Percentage of Patients Reporting Satisfaction with Treatment
Time frame: 5 Weeks
Percentage of Health Care Providers Reporting Satisfaction with Treatment
Time frame: 12 Weeks
3 secondary outcomes
Physical Functioning on a 5-Point Scale
Time frame: 5 Weeks
Severity of Pain on an 11-Point Scale
Time frame: 5 Weeks
Disability Assessment on a 4-Point Scale
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Derived from this study: PubMed 41025675Wissel J, List C, Schwartz M, Nelson M, Musacchio T, Duarte E. Relief of pain associated with spasticity in adult patients after treatment with onabotulinumtoxinA: Post hoc observational results from the ASPIRE study. PM R. 2026 Apr;18(4):410-425. doi: 10.1002/pmrj.70013. Epub 2025 Sep 30.
- Derived from this study: PubMed 38813838Bavikatte G, Francisco GE, Jost WH, Baricich A, Duarte E, Tang SFT, Schwartz M, Nelson M, Musacchio T, Esquenazi A. Pain, disability, and quality of life in participants after concurrent onabotulinumtoxinA treatment of upper and lower limb spasticity: Observational results from the ASPIRE study. PM R. 2024 Nov;16(11):1175-1189. doi: 10.1002/pmrj.13195. Epub 2024 May 30.
- Derived from this study: PubMed 38206635Bavikatte G, Esquenazi A, Dimyan MA, Dashtipour K, Feng W, Mayadev A, Fanning K, Musacchio T, Zuzek A, Francisco GE. Safety and Real-World Dosing of OnabotulinumtoxinA for the Treatment of Adult Spasticity: Post Hoc Analysis of the Adult Spasticity International Registry Study. Am J Phys Med Rehabil. 2024 Jul 1;103(7):580-587. doi: 10.1097/PHM.0000000000002410. Epub 2024 Jan 8.
- Derived from this study: PubMed 34245684Esquenazi A, Francisco GE, Feng W, Baricich A, Gallien P, Fanning K, Zuzek A, Bandari DS, Wittenberg GF. Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2172-2184.e6. doi: 10.1016/j.apmr.2021.06.008. Epub 2021 Jul 7.
- Derived from this study: PubMed 33151636Esquenazi A, Bavikatte G, Bandari DS, Jost WH, Munin MC, Tang SFT, Largent J, Adams AM, Zuzek A, Francisco GE. Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity. PM R. 2021 Oct;13(10):1079-1093. doi: 10.1002/pmrj.12517. Epub 2021 Jan 11.
- Derived from this study: PubMed 31953896Francisco GE, Jost WH, Bavikatte G, Bandari DS, Tang SFT, Munin MC, Largent J, Adams AM, Zuzek A, Esquenazi A. Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study. PM R. 2020 Nov;12(11):1120-1133. doi: 10.1002/pmrj.12328. Epub 2020 Feb 27.
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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.
Aleks Zuzek study director
Allergan
55 sites in 7 countries: 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 55 sites in 7 countries.
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 2 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Spain, Germany, France, United Kingdom and 2 more countries. 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?
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?
Percentage of Patients Reporting Satisfaction with Treatment (time frame: 5 Weeks). The study lists 2 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 NCT01930786, which also lists 6 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 11 Feb 2019.