SpasticityVALGASNCT01444794
Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
An observational study of Spasticity, run by Ipsen at 24 sites in Spain.
Trial summary
The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- How many people
- 100 participants
- Where
- 24 sitesSpain
- Study dates
- Sep 2011to Feb 2013
- 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: Primary care clinic
Who may be able to join
- Suffering from lower limb spasticity following stroke
- With at least a 12-week interval between the last BoNT-A injection and inclusion
- Decision already been agreed to inject BoNT-A
Who cannot join
- Documented positive antigenicity to botulinum toxin
- Any neuromuscular junction indication
- Severe muscle atrophy in any muscle to be injected
- Any other indication that might interfere with rehabilitation or the evaluation of results
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Spain24 sites
Hospital Maritimo de Oza
A Coruña
Hospital de Cruces
Barakaldo
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital de Bellvitge
Barcelona
Hospital Mutua de Terrassa
Barcelona
Hospital Sant Pau
Barcelona
Hospital Vall Hebron
Barcelona
Hospital Puerta del Mar
Cadiz
Hospital de Magdalena
Castellon
Hospital de Gorliz
Gorraiz
Hospital Dr. Negrín
Las Palmas de Gran Canaria
Hospital Insular
Las Palmas de Gran Canaria
Hospital De la Fundación Jimenez
Madrid
Hospital la Paz
Madrid
Hospital La Princesa
Madrid
Hospital Carlos Haya
Málaga
Hospital Virgen de la Victoria
Málaga
Hospital Morales Meseguer
Murcia
Hospital Ntra. Sra. De La Candelaria
Santa Cruz de Tenerife
Hospital de Valdecilla
Santander
Hospital La Fe
Valencia
Hospital Valencia al Mar
Valencia
Hospital Povisa
Vigo
Hospital Xeral de Vigo
Vigo
About this study
Official title: A National, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.
- Conditions
- Spasticity
- Keywords
- Lower limb spasticity
- Medical subject headings
- Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).
Assessed using the Goal Attainment Scale (GAS).
Measured: Between 1 and 3 months from inclusion
Secondary outcomes (4)
Overall attainment of treatment goals
Assessed using the GAS T-Score.
Measured: Between 1 and 3 months from inclusion
The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).
Measured: Up to 5 months
Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).
Measured: Up to 5 months
Global assessment of benefits by both the investigator and the subject (or guardian).
Assessed using a 5-point scale - much worse/worse/unchanged/better/much better
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444794
- Sponsor's protocol ID
- A-92-52120-159
- Acronym
- VALGAS
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2011
- Last updated
- 5 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
- ClinicalTrials.gov ID
- NCT01444794
- Acronym / sponsor ID
- VALGAS / A-92-52120-159
- Conditions
- Spasticity
- Keywords
- Lower limb spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Oct 2011 (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.
The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Suffering from lower limb spasticity following stroke
- With at least a 12-week interval between the last BoNT-A injection and inclusion
- Decision already been agreed to inject BoNT-A
Key exclusion criteria (4 listed)
- Documented positive antigenicity to botulinum toxin
- Any neuromuscular junction indication
- Severe muscle atrophy in any muscle to be injected
- Any other indication that might interfere with rehabilitation or the evaluation of results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS).
Time frame: Between 1 and 3 months from inclusion
Assessed using the Goal Attainment Scale (GAS).
4 secondary outcomes
Overall attainment of treatment goals
Time frame: Between 1 and 3 months from inclusion
The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests).
Time frame: Up to 5 months
Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography).
Time frame: Up to 5 months
Global assessment of benefits by both the investigator and the subject (or guardian).
Time frame: Up to 5 months
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 5 Nov 2020.
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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.
Ipsen Medical Director study director
Ipsen
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by Ipsen at 24 sites 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 3 inclusion and 4 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
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?
Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). (time frame: Between 1 and 3 months from inclusion). 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 5 Nov 2020.