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

• ClinicalTrials.gov Identifier: NCT02020980
• Recruitment Status: Completed
• First Posted: December 25, 2013
• Last Update Posted: July 29, 2019
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Tracking Information

• First Submitted Date: December 19, 2013
• First Posted Date: December 25, 2013
• Last Update Posted Date: July 29, 2019
• Study Start Date: April 2014
• Actual Primary Completion Date: March 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 19, 2013)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 19, 2013)

• 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).
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
• 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adult patients with post-stroke lower limb spasticity in Rehabilitation and Neurology Units of hospitals.
• Condition: Lower Limb Spasticity

Intervention

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®)

Study Groups/Cohorts

Post-stroke lower limb spasticity patients

Intervention: Biological: Botulinum toxin type A

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 30, 2016): 186
• Original Estimated Enrollment (submitted: December 19, 2013): 184
• Actual Study Completion Date: March 5, 2018
• Actual Primary Completion Date: March 5, 2018 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02020980
• Other Study ID Numbers: A-92-52120-181
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ipsen
• Study Sponsor: Ipsen
• Collaborators: Not Provided

Investigators

• Study Director: Ipsen Medical Director; Ipsen

• PRS Account: Ipsen
• Verification Date: July 2019