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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT02020980
First received: December 19, 2013
Last updated: November 25, 2014
Last verified: November 2014
  Purpose

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 Intervention
Lower Limb Spasticity
Drug: Botulinum Toxin Type A (BoNT-A) Injection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in Pain relief on Numeric Rating Scale [ Time Frame: Baseline visit and every 4 months up to 16 months (Visit 5). ] [ Designated as safety issue: No ]
    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:
  • Change in Pain relief on Visual Assessment Scale [ Time Frame: Baseline visit and every 4 months up to 16 months (Visit 5). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 184
Study Start Date: April 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Post-stroke lower limb spasticity patients Drug: Botulinum Toxin Type A (BoNT-A) Injection

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020980

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Spain
Hospital Marítimo Oza Recruiting
A Coruña, Spain
Hospital General de Albacete Not yet recruiting
Albacete, Spain
Hospital de Cruces Recruiting
Bilbao, Spain
Hospital de Galdácano Recruiting
Bilbao, Spain
Hospital Guadalajara Not yet recruiting
Guadalajara, Spain
Hospital Dr Negrín Not yet recruiting
Las Palmas, Spain
Hospital Insular Recruiting
Las Palmas, Spain
Hospital San Pedro Not yet recruiting
Logroño, Spain
Hospital Lugo Not yet recruiting
Lugo, Spain
Hospital 12 Octubre Recruiting
Madrid, Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain
Hospital Alcorcón Recruiting
Madrid, Spain
Hospital General de Móstoles Recruiting
Madrid, Spain
Hospital Principe de Asturias de Alcalá de Henares Recruiting
Madrid, Spain
Fundación Jimenez Díaz Recruiting
Madrid, Spain
Hospital Son Espases Recruiting
Mallorca, Spain
Hospital Ourense Not yet recruiting
Ourense, Spain
Clinica Ubarmin Recruiting
Pamplona, Spain
Hospital Virgen de la Vega Not yet recruiting
Salamanca, Spain
Hospital de Donosti Not yet recruiting
San Sebastián, Spain
Hospital Gral de Segovia Withdrawn
Segovia, Spain
Hospital Universitario Canarias Recruiting
Tenerife, Spain
Hospital de la Candelaria Recruiting
Tenerife, Spain
Hospital Virgen de la Salud Not yet recruiting
Toledo, Spain
Hospital Reina Sofía Recruiting
Tudela, Spain
Hospital Clinico Valladolid Recruiting
Valladolid, Spain
Hospital Xeral de Vigo Recruiting
Vigo, Spain
Hospital Universitario de Alaba Recruiting
Vitoria, Spain
Hospital de Basurto Recruiting
Vizcaya, Spain
Hospital Gorliz Recruiting
Vizcaya, Spain
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Elena Hernández Yuste, BSc. MBA Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02020980     History of Changes
Other Study ID Numbers: A-92-52120-181
Study First Received: December 19, 2013
Last Updated: November 25, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014