NCT02986880

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Botulinum toxin A
PROCEDURE	Placebo	Injection of sodium chloride (NaCl) 9/1000

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-01-10
• Completion: 2014-01-10
• First posted: 2016-12-08
• Last updated: 2017-05-25

Locations

1 site across 1 country: France