Muscle SpasticityNCT01383681
Retrospective Study of Patients With Spasticity in the Spanish Population
An observational study of Muscle Spasticity, run by Allergan at 1 site in Spain.
Trial summary
This is a retrospective study of patients with spasticity in the Spanish population. 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?
- No treatment
- How many people
- 235 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to Oct 2012
- 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: Patients with diagnosis of spasticity are selected from rehabilitation departments within the Spanish health system.
Who may be able to join
- Diagnosis of spasticity
Who cannot join
- Current enrollment in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study To Establish The Methodology Used In The Evaluation, Treatment And Assessment Of Progression Of Spasticity In The Spanish Population
This is a retrospective study of patients with spasticity in the Spanish population.
- Conditions
- Muscle Spasticity
- Being tested
- No treatment
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatmentOther
There was no treatment in this study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study. Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Assessment of Spasticity
The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.
Measured: Baseline
Physician Assessment of Spasticity
The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionOct 2012
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383681
- Sponsor's protocol ID
- MAF/AGN/NS/SPA/019
- Status last verified
- Sep 2013
- First submitted
- 27 Jun 2011
- Last updated
- 14 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study To Establish The Methodology Used In The Evaluation, Treatment And Assessment Of Progression Of Spasticity In The Spanish Population
- ClinicalTrials.gov ID
- NCT01383681
- Acronym / sponsor ID
- MAF/AGN/NS/SPA/019
- Conditions
- Muscle Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Posted 14 Nov 2013
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 retrospective study of patients with spasticity in the Spanish population.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No treatmentThis was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of spasticity are selected from rehabilitation departments within the Spanish health system.
Key inclusion criteria (1 listed)
- Diagnosis of spasticity
Key exclusion criteria (1 listed)
- Current enrollment in a clinical trial
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 |
|---|---|---|
| No treatmentThere was no treatment in this study. | Other | All Participants |
Primary outcome
Physician Assessment of Spasticity
Time frame: Baseline
The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.
Physician Assessment of Spasticity
Time frame: Month 12
The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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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 Spain.
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 1 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 14 Nov 2013. 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 Spain. 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 14 Nov 2013). 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?
Physician Assessment of Spasticity (time frame: Baseline). 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?
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 14 Nov 2013.