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)

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborator: Merz Pharmaceuticals
• Treatments: Botulinum Toxins

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