Clinical trial NCT00909883: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parkinson's Disease
Foot Dystonia
Keywords: Idiopathic Parkinson's disease
Foot (Tiptoe) dystonia
Botulinum Toxin
Muscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Merz Pharmaceuticals
First posted: 2009-05-29
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: one month after the injection of botulinum toxin/placebo
Secondary outcomes:
measure: 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.
timeFrame: one month after injections of placebo or Botulinum toxin
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Gabriel-Montpied
city: Paris
country: France
facility: Hôpital La Pitié Salpétrière
city: Pessac
country: France
facility: Hôpital Haut-Levêque
city: Toulouse
country: France
facility: CHU Purpan
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Franck Durif
role: PRINCIPAL_INVESTIGATOR
References: