Lower Limb SpasticityRELIEFNCT02020980
RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
An observational study of Lower Limb Spasticity, run by Ipsen at 28 sites in Spain.
Trial summary
The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Spasticity
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- How many people
- 186 participants
- Where
- 28 sitesSpain
- Study dates
- Apr 2014to 5 Mar 2018
- 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: Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.
Who may be able to join
- Men or women age 18 years and above
- Post-stroke lower-limb spasticity
- Prior agreement with the patient to inject BoNT-A
- If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion).
- Therapeutic goals agreed jointly with the patient
- Functional Ambulation Classification (FAC) score 2-5
- Capacity to comply with the protocol
- Written informed consent
Who cannot join
- Documented positive antigenicity to botulinum toxin
- Neuromuscular disease
- Use of medications that interfere with neuromuscular transmission
- Severe muscle atrophy in any muscle to be injected
- Any other indication that might interfere with rehabilitation or the evaluation of results
- Any non-stroke spasticity diagnosis
- Pregnancy or nursing mothers
- Previous participation in any study using Goal Attainment Scale (GAS)
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Spain28 sites
Hospital Marítimo Oza
A Coruña
Hospital General de Albacete
Albacete
Hospital de Basurto
Bilbao
Hospital de Cruces
Bilbao
Hospital de Galdácano
Bilbao
Hospital Gorliz
Bilbao
Hospital Guadalajara
Guadalajara
Hospital Dr Negrín
Las Palmas de Gran Canaria
Hospital Insular
Las Palmas de Gran Canaria
Hospital San Pedro
Logroño
Fundación Jimenez Díaz
Madrid
Hospital 12 Octubre
Madrid
Hospital Alcorcón
Madrid
Hospital General de Móstoles
Madrid
Hospital Principe de Asturias de Alcalá de Henares
Madrid
Hospital Universitario de la Princesa
Madrid
Hospital Ourense
Ourense
Hospital Son Espases
Palma de Mallorca
Clinica Ubarmin
Pamplona
Hospital Virgen de la Vega
Salamanca
Hospital de Donosti
San Sebastián
Hospital de la Candelaria
Santa Cruz de Tenerife
Hospital Universitario Canarias
Santa Cruz de Tenerife
Hospital Virgen de la Salud
Toledo
Hospital Reina Sofía
Tudela
Hospital Clinico Valladolid
Valladolid
Hospital Xeral de Vigo
Vigo
Hospital Universitario de Alaba
Vitoria-Gasteiz
About this study
Official title: A Prospective, Observational Study to Assess Pain Relief After 4 Botulinum Toxin Type A (BoNT-A) Injection Cycles in Patients With Post-stroke Lower Limb Spasticity
The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Thus, this study will help to expand the information that is available regarding the impact of BoNT-A treatment in routine clinical practice conditions.
Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.
- Conditions
- Lower Limb Spasticity
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
This is an observational study designed to reflect the clinical practice in real life as closely as possible.
Botulinum Toxin Type A (BoNT-A) injection administered according to the local Summary of Product Characteristics (SmPC) and the locally agreed treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Post-stroke lower limb spasticity patients | Not described Receives: Biological: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain relief on Numeric Rating Scale
Pain relief evaluated by Numeric Rating Scale (NRS). The NRS score for patient self-reporting of pain ranging from 0 (no pain) to 10 (the most severe pain).
Measured: Baseline visit and every 4 months up to 16 months (Visit 5).
Secondary outcomes (2)
Change in Pain relief on Visual Assessment Scale
Pain relief evaluated by measuring changes in Visual Assessment Scale (VAS). The VAS used a 100 mm line in which values were reported, 0 (no pain) to 10 (the most severe pain).
Measured: Baseline visit and every 4 months up to 16 months (Visit 5).
Responder rate using goal Attainment Scale
Responder rate assessed on the Goal Attainment Scale (GAS). GAS is a 5-point scale, with the degree of attainment captured for each goal area.
Measured: Every 4 months up to 16 months (Visit 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startApr 2014
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb 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
- 186 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
- NCT02020980
- Sponsor's protocol ID
- A-92-52120-181
- Acronym
- RELIEF
- Status last verified
- Jul 2019
- First submitted
- 19 Dec 2013
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Assess Pain Relief After 4 Botulinum Toxin Type A (BoNT-A) Injection Cycles in Patients With Post-stroke Lower Limb Spasticity
- ClinicalTrials.gov ID
- NCT02020980
- Acronym / sponsor ID
- RELIEF / A-92-52120-181
- Conditions
- Lower Limb Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 25 Dec 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.
The objective of this study is to demonstrate the effect of intramuscular BoNT-A injections in relieving pain, in a broad population of patients who suffer pain as the primary problem associated with spasticity. Thus, this study will help to expand the information that is available regarding the impact of BoNT-A treatment in routine clinical practice conditions.
Treatment goals can vary greatly from one patient to another and there is no unique, single outcome that reflects the treatment benefits in all the cases. Therefore, this study with special focus on the achievement of therapeutic goals, will allow the identification of each patient's specific goals regarding the improvement of the functional outcomes, the quality of life and patient well-being.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-stroke lower limb spasticity patients | – | Biological: Botulinum toxin type A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.
Key inclusion criteria (8 listed)
- Men or women age 18 years and above
- Post-stroke lower-limb spasticity
- Prior agreement with the patient to inject BoNT-A
- If previously treated with BoNT-A, (at least 3 months interval between last injection and inclusion).
- Therapeutic goals agreed jointly with the patient
Key exclusion criteria (8 listed)
- Documented positive antigenicity to botulinum toxin
- Neuromuscular disease
- Use of medications that interfere with neuromuscular transmission
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®)This is an observational study designed to reflect the clinical practice in real life as closely as possible. Botulinum Toxin Type A (BoNT-A) injection administered according to the local Summary of Product Characteristics (SmPC) and the locally agreed treatment guidelines. | Biological | Post-stroke lower limb spasticity patients |
Primary outcome
Change in Pain relief on Numeric Rating Scale
Time frame: Baseline visit and every 4 months up to 16 months (Visit 5).
Pain relief evaluated by Numeric Rating Scale (NRS). The NRS score for patient self-reporting of pain ranging from 0 (no pain) to 10 (the most severe pain).
2 secondary outcomes
Change in Pain relief on Visual Assessment Scale
Time frame: Baseline visit and every 4 months up to 16 months (Visit 5).
Responder rate using goal Attainment Scale
Time frame: Every 4 months up to 16 months (Visit 5).
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 29 Jul 2019.
Related trials for Lower Limb Spasticity
Active, not recruitingPhase 3
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Not yet recruiting
Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity
Stroke, Post-stroke Spasticity of the Lower Limb
Recruiting
Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity
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Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke
Stroke, Equinovarus Foot
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
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Spasticity, run by Ipsen at 28 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 8 inclusion and 8 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 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
Change in Pain relief on Numeric Rating Scale (time frame: Baseline visit and every 4 months up to 16 months (Visit 5).). 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 29 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.