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RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke (RELIEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020980
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief 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. 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.


Condition or disease Intervention/treatment
Lower Limb Spasticity Biological: Botulinum toxin type A

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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2014
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Group/Cohort Intervention/treatment
Post-stroke lower limb spasticity patients Biological: Botulinum toxin type A

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.

Other Name: AbobotulinumtoxinA (Dysport®)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change in Pain relief on Visual Assessment Scale [ Time Frame: Baseline visit and every 4 months up to 16 months (Visit 5). ]
    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).

  2. Responder rate using goal Attainment Scale [ Time Frame: Every 4 months up to 16 months (Visit 5). ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020980


Locations
Show Show 28 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02020980    
Other Study ID Numbers: A-92-52120-181
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents