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)

Parkinson's Disease Clinical Trial

— RBHP 2008  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00909883
• Other study ID #: CHU-0051
• Status: Recruiting
• Phase: Phase 3
• First received: May 19, 2009
• Last updated: March 24, 2011
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: March 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick Lacarin
• Phone: 04.73.75.11.95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Foot Dystonia
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Botulinum Toxin: Xeomin
45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
• Placebo
Placebo injection

Locations

Country	Name	City	State
France	CHU Gabriel-Montpied	Clermont-Ferrand
France	Hôpital La Pitié Salpétrière	Paris
France	Hôpital Haut-Levêque	Pessac
France	CHU Purpan	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Merz Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		one month after the injection of botulinum toxin/placebo	Yes
Secondary	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.		one month after injections of placebo or Botulinum toxin	Yes