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:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01239628
First received: November 10, 2010
Last updated: March 27, 2014
Last verified: March 2014
  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 ]

Enrollment: 34
Study Start Date: December 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (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
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: 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: March 27, 2014
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 July 24, 2014