Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

NCT ID: NCT00432055

Last Updated: 2009-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-01-31

Brief 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.

Detailed 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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

I

Botox

Group Type: EXPERIMENTAL

Botulinum toxin type A (Botox)

Intervention Type: DRUG

II

Group Type: PLACEBO_COMPARATOR

placebo (saline)

Intervention Type: DRUG

Interventions

Botulinum toxin type A (Botox)

Intervention Type: DRUG

placebo (saline)

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role: collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sunnaas Rehabilitation Hospital

Principal Investigators

Johan K Stanghelle, Professor MD

Role: STUDY_CHAIR

Research Departement, Sunnaas Rehabilitation Hospital

Locations

Sunnaas Rehabilitation Hospital

Bjoernemyr, Nesoddtangen, Norway

Countries

Norway

Other Identifiers

EudraCTnumber: 2006-001427-19

Identifier Type: -

Identifier Source: secondary_id

20624503

Identifier Type: -

Identifier Source: org_study_id