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Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432055
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : February 24, 2009
The Royal Norwegian Ministry of Health
Information provided by:
Sunnaas Rehabilitation Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Botulinum toxin type A (Botox) Drug: placebo (saline) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: I
Drug: Botulinum toxin type A (Botox)
Placebo Comparator: II Drug: placebo (saline)

Primary Outcome Measures :
  1. Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis) [ Time Frame: 8 week ]
  2. Summary measure of health related quality of life (SF-36) [ Time Frame: 8 week , 16 week ]

Secondary Outcome Measures :
  1. Stiffness/spasticity according to VAS [ Time Frame: 8 week, 16 week ]
  2. Questionnaire gait function [ Time Frame: 8 week, 16 week ]
  3. Spasticity in ankle, knee and hip according to Modified Ashworth Scale [ Time Frame: 8 week, ]
  4. 3D-gait data (Kinetics,Temporospatial (stride length, velocity) [ Time Frame: 8 week ]
  5. Global Scale [ Time Frame: 8 week, 16 week ]
  6. Timed Up and Go [ Time Frame: 8 week ]
  7. 6 minutes walking test [ Time Frame: 8 week ]
  8. Registrations of sample characteristics [ Time Frame: 0 week ]
  9. Registration of adverse reactions [ Time Frame: 8 week, 16 week ]
  10. Pain according to VAS [ Time Frame: 8 week, 16 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432055

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Sunnaas Rehabilitation Hospital
Bjoernemyr, Nesoddtangen, Norway, 1450
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
The Royal Norwegian Ministry of Health
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Study Chair: Johan K Stanghelle, Professor MD Research Departement, Sunnaas Rehabilitation Hospital
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Responsible Party: Johan K Stanghelle, Sunnaas Rehabilitation Hospital Identifier: NCT00432055    
Other Study ID Numbers: 20624503
EudraCTnumber: 2006-001427-19
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009
Keywords provided by Sunnaas Rehabilitation Hospital:
Cerebral Palsy
Spastic contractures
Botulinum toxin type A
Additional relevant MeSH terms:
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Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents