NCT02434549

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_2 pain

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

April 30, 2015

Last Update Submit

October 6, 2018

Conditions

PainCerebral Palsy, Spastic

Keywords

Randomized Controlled TrialPlacebo ControlledDouble BlindedBotulinum Toxin Type AAdultsPainSpasticityCerebral Palsy, SpasticDysport

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Use of other analgesic treatment

    Six weeks after treatment

  • Pain interference

    Six weeks after treatment

Other Outcomes (6)

  • HRQoL (Health-Related Quality of Life)

    Six weeks after treatment

  • Global Impression of Change

    Six weeks after treatment

  • Fatigue Severity Scale

    Six weeks after treatment

  • +3 more other outcomes

Study Arms (2)

Botulinum toxin-A (Dysport®)

ACTIVE COMPARATOR

Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain

Drug: Dysport®

Normal saline

PLACEBO COMPARATOR

Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain

Drug: Normal saline

Interventions

Dysport®DRUG

Intramuscular injections in spastic muscle with regional muscle-related pain

Also known as: AbobotulinumtoxinA
Botulinum toxin-A (Dysport®)
Normal salineDRUG

Intramuscular injections in spastic muscle with regional muscle-related pain

Also known as: 0.9 % NaCl, Physiological saline
Normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Rehabilitation Medicine at Danderyd Hospital AB

Danderyd, 182 88, Sweden

Location

Astrid Lindgren's Children's Hospital at Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Related Publications (1)

  • Jacobson D, Lowing K, Kullander K, Rydh BM, Tedroff K. A First Clinical Trial on Botulinum Toxin-A for Chronic Muscle-Related Pain in Cerebral Palsy. Front Neurol. 2021 Aug 16;12:696218. doi: 10.3389/fneur.2021.696218. eCollection 2021.

    PMID: 34484101DERIVED

MeSH Terms

Conditions

PainCerebral PalsyMuscle Spasticity

Interventions

abobotulinumtoxinASaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Kristina Tedroff, MD, PhD

    Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD. Associate Professor. Senior Consultant Physician.

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

August 1, 2015

Primary Completion

January 26, 2018

Study Completion

October 5, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

SE(2)