Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial

Pain Clinical Trial

— BATCP  

Official title:

Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02434549
• Other study ID #: BATCP
• Status: Terminated
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: October 5, 2018

Study information

• Verified date: October 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this double-blinded, placebo-controlled study is to test if treatment with Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 5, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Spastic Cerebral Palsy.

• Chronic pain, related to spastic muscle. Chronic pain defined as: 1)Recurring regional pain for at least three months AND 2)Pain intensity on average for the last 24 hours =3 on Numerical Rating Scale.

• Signed Informed consent.

Exclusion Criteria:

• Allergy/hypersensitivity to Dysport® or any of its components.

• Pregnancy.

• Women who breastfeed their children.

• Treatment with Botulinum toxin-A within the last five months.

• If there has been dose changes in any muscle-tone altering medication within two weeks of Visit 1.

• A clear degenerative cause behind the pain as elucidated by the clinical examination (e.g. history of osteoarthritis).

• Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Muscle Spasticity
• Pain
• Paralysis

Intervention

Drug:
• Dysport®
Intramuscular injections in spastic muscle with regional muscle-related pain
• Normal saline
Intramuscular injections in spastic muscle with regional muscle-related pain

Locations

Country	Name	City	State
Sweden	Department of Rehabilitation Medicine at Danderyd Hospital AB	Danderyd
Sweden	Astrid Lindgren's Children's Hospital at Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Kristina Tedroff	Danderyd Hospital, Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HRQoL (Health-Related Quality of Life)	Mean change at Visit 3 (six weeks after treatment) compared to baseline in the Short Form 36 v2 Health-related Quality of Life questionnaire (SF-36v2)	Six weeks after treatment
Other	Global Impression of Change	Proportion of responders at Visit 3 (six weeks after treatment) in the Global Impression of Change Scale (PGIC) derived as at least "Minimally improved".	Six weeks after treatment
Other	Fatigue Severity Scale	Proportion of responders at Visit 3 (six weeks after treatment) in the Fatigue Severity Scale (FSS) derived as a reduction in mean score of =1 point.	Six weeks after treatment
Other	Spasticity	Proportion of responders at Visit 3 (six weeks after treatment) derived as achieving reduction of spasticity of >1 scale steps on the Modified Ashworth Scale (MAS)	Six weeks after treatment
Other	Range of Motion	Proportion of responders at Visit 3 (six weeks after treatment) derived as improvement in passive joint range of motion (ROM) = 10 degrees.	Six weeks after treatment
Other	Adverse Events	Frequency of adverse events	Six weeks after treatment
Primary	Pain intensity	Proportion of responders derived as reduction of intensity of pain of =2 points on the Numerical Rating Scale (NRS) at Visit 3 (six weeks after treatment) compared to baseline.	Six weeks after treatment
Secondary	Use of other analgesic treatment	Categories of change in the use of analgesic treatments, derived as Increase, No change, or Decrease at Visit 3 (six weeks after treatment), compared to baseline.	Six weeks after treatment
Secondary	Pain interference	Proportion of responders derived as a reduction in mean interference score of =1 on the Brief Pain Inventory (BPI-SF) at Visit 3 (six weeks after treatment) compared to baseline.	Six weeks after treatment