A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke (DECIDE)
This study is ongoing, but not recruiting participants.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01239628
First received: November 10, 2010
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition |
|---|
|
Upper Limb Spasticity After Stroke |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A National, Prospective, Non-interventional Survey 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 Post-CVA (Cerebrovascular Accident) |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Documentation of the injection intervals [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Documentation of treatment modalities [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Documentation of the main reason(s) for change in injection intervals [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Documentation of the main reason(s) for dose change(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Documentation of the patient satisfaction with the treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Documentation of the physician satisfaction with the treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
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
Patients with a history of stroke, suffering from upper limb spasticity
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239628
Locations
| Belgium | |
| St- Augustinus | |
| Antwerpen, Belgium | |
| ZNA Middelheim | |
| Antwerpen, Belgium | |
| Revalidatieziekenhuis Hof Ter Schelde | |
| Antwerpen, Belgium | |
| AZ St-Jan | |
| Brugge, Belgium, 8000 | |
| AZ Saint Lucas | |
| Gent, Belgium, 9000 | |
| Virga Jesseziekenhuis | |
| Hasselt, Belgium | |
| ZOL, Campus Sint Barbara | |
| Lanaken, Belgium | |
| Heilig Hart Ziekenhuis | |
| Lier, Belgium | |
| CHU Vesale | |
| Montigny-Le-Tilleul, Belgium | |
| CHPLT/CRF Peltzer | |
| Verviers, Belgium | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Medical Director, Neurology | Ipsen |
More Information
No publications provided
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT01239628 History of Changes |
| Other Study ID Numbers: | A-48-52120-152 |
| Study First Received: | November 10, 2010 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Muscle Spasticity Stroke Cerebral Infarction Stress, Psychological Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Behavioral Symptoms Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013