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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) (RBHP 2008)

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ClinicalTrials.gov Identifier: NCT00909883
Recruitment Status : Unknown
Verified March 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : May 29, 2009
Last Update Posted : March 25, 2011
Sponsor:
Collaborator:
Merz Pharmaceuticals
Information provided by:
University Hospital, Clermont-Ferrand

May 19, 2009
May 29, 2009
March 25, 2011
September 2009
September 2011   (Final data collection date for primary outcome measure)
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 ]
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: after an injection of placebo or Botulium toxin ]
Complete list of historical versions of study NCT00909883 on ClinicalTrials.gov Archive Site
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 ]
Furthermore, most of injections were realised in the leg muscle (for example in Flexor digitorum longus muscle). [ Time Frame: after an injection of placebo or Botulinum toxin ]
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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)
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)

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).

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).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Parkinson's Disease
  • Foot Dystonia
  • Drug: Botulinum Toxin: Xeomin
    45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
  • Drug: Placebo
    Placebo injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
45
Same as current
September 2012
September 2011   (Final data collection date for primary outcome measure)

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:

  • 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
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00909883
CHU-0051
Not Provided
Not Provided
Not Provided
Pr Franck DURIF, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
Merz Pharmaceuticals
Principal Investigator: Franck Durif University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP