Upper Limb Spasticity After Stroke Clinical Trial
— DECIDEOfficial title:
A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)
| NCT number | NCT01239628 |
| Other study ID # | A-48-52120-152 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 2010 |
| Est. completion date | December 2015 |
| Verified date | March 2020 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.
| Status | Terminated |
| Enrollment | 45 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subject able to comply with the protocol - Provision of written informed consent prior to collecting the data - Male or female patients of 18 years or older - Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated Exclusion Criteria: - The subject has already been included in this survey - Patients who already received BoNT-A treatment for upper limb spasticity - Patients with known intolerance for BoNT-A - Subjects unable to comply with the protocol |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | St- Augustinus | Antwerpen | |
| Belgium | ZNA Middelheim | Antwerpen | |
| Belgium | AZ St-Jan | Brugge | |
| Belgium | RevalidatieZiekenhuis RevArte | Edegem | |
| Belgium | AZ Sint Lucas | Gent | |
| Belgium | Revalidatiecentrum St Ursula | Herk-de-Stad | |
| Belgium | ZOL, Campus Sint Barbara | Lanaken | |
| Belgium | Heilig Hart Ziekenhuis | Lier | |
| Belgium | Hôpital Marie Curie | Lodelinsart | |
| Belgium | CHU Leonardo da Vinci | Montigny-le-Tilleul | |
| Belgium | CHPLT Peltzer | Verviers |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Documentation of the injection intervals | 3 years | ||
| Primary | Documentation of treatment modalities | 3 years | ||
| Secondary | Documentation of the main reason(s) for change in injection intervals | 3 years | ||
| Secondary | Documentation of the main reason(s) for dose change(s) | 3 years | ||
| Secondary | Documentation of the patient satisfaction with the treatment | 3 years | ||
| Secondary | Documentation of the physician satisfaction with the treatment | 3 years |