Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432055
• Other study ID #: 20624503
• Secondary ID: EudraCTnumber: 2
• Status: Completed
• Phase: Phase 4
• First received: February 5, 2007
• Last updated: February 23, 2009
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Sunnaas Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment.

Description:

Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lifelong motor dysfunction resulting rom a non-progressive brain lesion occurring pre-, peri- or postnatal before the second year of life. CP consists of different aspect of motor disorder including spasticity, paresis, incoordination and dystonia

There is scarce knowledge about the association between spasticity, pain and physical function in the adult CP-population, and the systematic follow up of patients with CP typically ends at the age of eighteen. Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A (Btx-A) in leg and thigh muscles, and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation.

Botulinum toxin A (Btx- A) is a highly effective treatment in the management of spasticity. The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al. Subsequently, randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP. There is an implicit, and as of yet, unproven assumption that there is no indication for this treatment in the adult CP-population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Unilateral or bilateral spastic CP

• Modified Ashworth Scale (MAS) = 2 in ankle- or knee joint muscles.

• = 18 year of age, = 65 year of age

• Ambulant without walking aids minimum 10 metres in functional equines and/or with pathological knee extension or flexion pattern.

Exclusion Criteria:

• Cognitive impairment.

• No spasticity (MAS < 2 )

• < 18 year of age

• Not ambulant without walking aids

• Pregnant or planning pregnancy

• Btx-A treatment last 6 months

• Orthopedic surgery lower extremity last 18 months

• Obvious skeletal/joint deformity where orthopedic surgery is indicated

• Other diseases which can affect level of function (rheumatoid or neurological )

• New treatment the past four weeks which affect the musculoskeletal system (pain killers, physical therapy, acupuncture)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Drug:
• Botulinum toxin type A (Botox)

• placebo (saline)

Locations

Country	Name	City	State
Norway	Sunnaas Rehabilitation Hospital	Bjoernemyr	Nesoddtangen

Sponsors (2)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis)		8 week	No
Primary	Summary measure of health related quality of life (SF-36)		8 week , 16 week	No
Secondary	Stiffness/spasticity according to VAS		8 week, 16 week	No
Secondary	Questionnaire gait function		8 week, 16 week	No
Secondary	Spasticity in ankle, knee and hip according to Modified Ashworth Scale		8 week,	No
Secondary	3D-gait data (Kinetics,Temporospatial (stride length, velocity)		8 week	No
Secondary	Global Scale		8 week, 16 week	No
Secondary	Timed Up and Go		8 week	No
Secondary	6 minutes walking test		8 week	No
Secondary	Registrations of sample characteristics		0 week	No
Secondary	Registration of adverse reactions		8 week, 16 week	No
Secondary	Pain according to VAS		8 week, 16 week	No