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)

Sponsor
University Hospital, Clermont-Ferrand
Study ID
NCT00909883
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Sep 30, 2009
Status verified
Mar 2011
Primary completion
Sep 30, 2011
Completion
Sep 30, 2012

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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 ]

Central Contacts

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