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Status unknownNCT00909883RBHP 2008Updated Mar 25, 2011

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)

A Phase 3 interventional study of Botulinum Toxin: Xeomin and Placebo in Parkinson's Disease and Foot Dystonia, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 4 sites in France. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-03-25.

Sponsored by University Hospital, Clermont-Ferrand · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

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).

Read the detailed description

Study progress :

After an inclusion visit, patients are randomized in one of the 3 following groups :

  • First group (PL : placebo) :

    • J0 : Patient will receive 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
    • J+1month : First evaluation
    • J+3 months : Patient will receive again 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
    • J+4 months : Last evaluation

  • Second group (ME : Extrinsic muscle)

    • J0 : Patient will receive 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
    • J+1 month : First evaluation
    • J+3 months : Patient will receive again 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae
    • J+4 months : Last evaluation

  • Third group (MI : Intrinsic muscle)

    • J0 : Patient will receive 1 injection of placebo in the Flexor digitorum longus and 1 injection of Botulinum toxin (100U) in the Flexor digitorum brevis or in the quadratus plantae
    • J+1 month : First evaluations
    • J+3 months : Patient will receive again 1 injection of placebo in the Flexor digitorum longus and 1 injection of Botulinum toxin (100U) in the Flexor digitorum brevis or in the quadratus plantae
    • J+4 months : Last evaluations

During injections (J0 and J+3M), we will measure the pain induced by injections (EVA) For each evaluation (J+1M and J+4M), following evaluations will be made: clinical improvement (CGI), dystonia evaluation (duration and severity, Burke scale), pain (EVA) and quality of life (PDQ39).

02

Conditions studied

  • Parkinson's Disease
  • Foot Dystonia

Keywords

  • Idiopathic Parkinson's disease
  • Foot (Tiptoe) dystonia
  • Botulinum Toxin
  • Muscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae
03

In context

Parkinson Disease

4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's planned enrollment of 45 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age : 30-75 years
  • Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank"
  • Patient with unilateral tiptoe dystonia. Dystonia must be present more than 1h /day and induce difficulties to walk (severity index ≥ 3 (1 : light, 2 : moderate, 3 : severe, 4 : very severe)).
  • Patients never treated with botulinum toxin or already treated for more than 6 months.
  • Affiliation to social security
  • Agreement of patients

Exclusion criteria

Exclusion Criteria:

  • Patients suffering of an atypical Parkinson syndrome
  • Patient with a bilateral tiptoe dystonia
  • Patients with contraindication to the botulinum toxin use
  • Women without efficient contraception
  • Person who participate to an other study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (estimated)

Interventions

  • DrugBotulinum Toxin: Xeomin

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

  • DrugPlacebo

    Placebo injection

06

What researchers measure

Primary outcomes

  1. In a controlled double blind and randomized study, we want to show that intramuscular injections of botulinum toxin are beneficial to reduced dystonia and associated pain in patient with foot dystonia (compared to placebo injections).

    Time frame: one month after the injection of botulinum toxin/placebo

Secondary outcomes

  1. Efficiency comparison of injections made in leg muscle (Flexor digitorum longus) between injections made directly in foot muscle (Flexor digitorum brevis or quadratus plantae) - Effects of injections on pain and quality of life.

    Time frame: one month after injections of placebo or Botulinum toxin

07

Study locations

1 of 4 sites recruiting
  • CHU Gabriel-Montpied
    Clermont-Ferrand, 63003, France
    Recruiting
  • Hôpital La Pitié Salpétrière
    Paris, 75651, France
    Not yet recruiting
  • Hôpital Haut-Levêque
    Pessac, 33600, France
    Not yet recruiting
  • CHU Purpan
    Toulouse, 31059, France
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00909883
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Merz Pharmaceuticals
First posted
May 29, 2009
Start date
Sep 2009
Primary completion
Sep 2011 (estimated)
Completion
Sep 2012 (estimated)
Last update
Mar 25, 2011

Study contacts

Patrick Lacarin
Contact
placarin@chu-clermontferrand.fr
04.73.75.11.95
Franck Durif
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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