MedTrace Logo

Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

NCT02986880 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-05-25

No results posted yet for this study

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.

Conditions

  • Cervical Spasm
  • Radiotherapy Side Effect
  • Botulinum Toxin

Interventions

DRUG

Botulinum toxin A

PROCEDURE

Placebo

Injection of sodium chloride (NaCl) 9/1000

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Christine Bach · Hopital Foch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-01-10
Completion
2014-01-10

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02986880 on ClinicalTrials.gov