A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

Hopital Foch1 site in 1 country14 target enrollmentJune 2011

ConditionsCervical Spasm Radiotherapy Side Effect Botulinum Toxin

InterventionsBotulinum toxin A Placebo

DrugsBotulinum toxin A

Overview

Phase: Phase 2
Intervention: Botulinum toxin A
Conditions: Cervical Spasm
Sponsor: Hopital Foch
Enrollment: 14
Locations: 1
Primary Endpoint: Cervical mobility degree
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.

The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

January 10, 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients from 18 to 75 years old;
•malignant Tumor of aerodigestive ways, in forgiveness;
•Treatment containing the external radiotherapy ended since \> 6 months
•Life expectancy \> 6 months;
•patient complaining from cervical spasms with functional disability;
•Negative Pregnancy test;
•Women under effective contraception;
•Patients benefiting from a national insurance scheme;
•Patient having given a written consent.

Exclusion Criteria

•Cervico-facial Surgery with reconstruction by pedicled flap
•Implantable Chamber with catheter in the internal jugular vein near the spasm;
•Muscular, neurological Pathology or malformative pulling a disorder of perception of the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper limbs;
•Disorder generalized by the muscular activity (ex myasthenia);
•Cervical osseous or muscular Pathology pulling pains and disability before the beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the cervical radiography, the slipped disc);
•Previous cervical injection of botulinum toxin ;
•Local Infection at the level of one of the sites proposed for injection;
•Histories of epilepsy;
•Patients presenting a hypersensitivity to the botulinum neurotoxin A or in one of its excipients;
•Patients under anticoagulation therapy, Under antibiotic treatment by aminoglycosides or amino 4 quinoline, under myorelaxant treatment or that must undergo an intervention with curarisation;

Arms & Interventions

Group D1

Patients receiving the toxin in SCM and the placebo in trapezius muscle and splenius capitis. Patients receiving the dose of 30 units (U) at injection point, totalling 120 U.