Trials / Completed
CompletedNCT02020980
RELIEF Study: Lower Limb Pain Relief After Injection Cycles in Adults Suffering From Lower Limb Spasticity Following Stroke
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 186 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2018-03-05
- Completion
- 2018-03-05
- First posted
- 2013-12-25
- Last updated
- 2019-07-29
Locations
28 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT02020980. Inclusion in this directory is not an endorsement.