Dysport® Pediatric Lower Limb Spasticity Follow-on Study

NCT ID: NCT01251380

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-01-31

Brief Summary

The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.

Conditions

Cerebral Palsy; Muscle Spasticity; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dysport

Dysport was injected into either one or both lower limbs in up to 4 cycles of treatment, a minimum of 12 weeks apart and up to a maximum of 40 weeks apart. Doses varied from 5 Units (U)/Kg to 20 U/kg for one leg, or from 10 U/Kg to 30 U/kg for two legs, with a maximum dose of no more than 30 U/Kg overall, or 1000 U, whichever was reached first.

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: BIOLOGICAL

Intramuscular (IM) injection on day 1 of each treatment cycle.

Interventions

Botulinum toxin type A

Intramuscular (IM) injection on day 1 of each treatment cycle.

Intervention Type: BIOLOGICAL

Other Intervention Names

AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

Inclusion Criteria

Subjects were eligible for participation in the study if they met the following criteria:

1. Completion of the double blind study (Study 141) up to the Week 12, Week 16, Week 22 or Week 28 follow up visit.

2. Without any major protocol deviations and/or any ongoing adverse events (AEs), either of which, in the opinion of the Investigator would pose an unacceptable risk to the subject were he/she to continue receiving treatment in this open label extension study.

3. Written informed consent obtained from the child's parent(s)/guardian(s) for this study, and assent from the child when and where applicable.

Exclusion Criteria

Subjects were excluded from entering the study for the following reasons:

1. Major limitation in the passive range of motion at the ankle, as defined by maximum ankle dorsiflexion measured by the angle of arrest (XV1) at slow speed <80° (TS angle) in the most affected leg to be injected.

2. Unwillingness or inability to comply with the protocol.

3. Current need for surgery for spasticity of the gastrocnemius-soleus complex (GSC) and/or hamstring muscles (and/or tendons) in the most affected leg to be injected.

4. Treatment with any drug that interferes either directly or indirectly with neuromuscular function (e.g. aminoglycoside antibiotics) or neuroblocking agents used during surgery (e.g. curare) within the last 30 days prior to study medication or a planned treatment with such drugs.

5. Be pregnant and/or lactating.

6. Female subjects, not willing to use contraceptive measures throughout the course of the study if post pubertal and sexually active.

7. An infection at the injection site(s).

8. Planned treatment with any new investigational drug or device during the study period.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Study Director

Role: STUDY_DIRECTOR

Ipsen

Locations

The Children's Hospital

Aurora, Colorado, United States

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Gillette Children's Speciality Healthcare

Saint Paul, Minnesota, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Shriner's Hospital for Children

Portland, Oregon, United States

Texas Scottish Rite - Hospital for Children

Dallas, Texas, United States

Club De Leones Cruz Del Sur Rehabilitation Corporation Punta Arenas

Punta Arenas, , Chile

Dr Roberto Del Rio Hospital

Santiago, , Chile

Neurorehabilitation Laboratory, Pontifical Catholic University

Santiago, , Chile

CHU Jean Minjoz

Besançon, , France

Hospital San José Celaya

Celaya, , Mexico

Centro de Rehabilitacion Infantil

Mexico City, , Mexico

Centro de Rehabilitacion Integral de Queretaro (CRIQ)

Querétaro, , Mexico

Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU

Gdansk, , Poland

B i L- Specjalistyczne Centrum Medyczne

Lodz, , Poland

Non-public Healthcare Unit - Grunwaldzka Clinic

Poznan, , Poland

Non-public Healthcare Unit Mazovian Neurorehabilitatio

Wiązowna, , Poland

Ghulane Military Medical Academy and School of Medicine

Ankara, , Turkey (Türkiye)

Ibn-i-Sina Hospital

Ankara, , Turkey (Türkiye)

Yildirim Beyazit Training and Research Hospital

Ankara, , Turkey (Türkiye)

GATA Haydarpasa Training Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Istanbul University Medical School

Istanbul, , Turkey (Türkiye)

Dokuz Eylül University Medical Faculty

Izmir, , Turkey (Türkiye)

Kocaeli University Medical Faculty

İzmit, , Turkey (Türkiye)

Countries

United States; Chile; France; Mexico; Poland; Turkey (Türkiye)

Other Identifiers

2010-019102-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Y-55-52120-147

Identifier Type: -

Identifier Source: org_study_id