Status:
UNKNOWN
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)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Merz Pharmaceuticals
Conditions:
Parkinson's Disease
Foot Dystonia
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
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 f...
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 Flex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00909883
Start Date
September 1 2009
End Date
September 1 2012
Last Update
March 25 2011
Active Locations (4)
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1
CHU Purpan
Toulouse, Toulouse, France, 31059
2
CHU Gabriel-Montpied
Clermont-Ferrand, France, 63003
3
Hôpital La Pitié Salpétrière
Paris, France, 75651
4
Hôpital Haut-Levêque
Pessac, France, 33600