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Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles)

NCT00909883 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-03-25

No results posted yet for this study

Summary

Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is characterized by an abnormal involuntary movement which is very uncomfortable (difficult to walk) and painful for the patient.

Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum longus, different doses used, heterogeneous population with many types of dystonia included, open studies).

Conditions

Interventions

DRUG

Botulinum Toxin: Xeomin

45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study

DRUG

Placebo

Placebo injection

Sponsors & Collaborators

  • Merz Pharmaceuticals

    collaborator INDUSTRY

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Franck Durif · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-09-30
Completion
2012-09-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00909883 on ClinicalTrials.gov