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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) (RBHP 2008)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merz Pharma France
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00909883
First received: May 19, 2009
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease
Foot Dystonia
Drug: Botulinum Toxin: Xeomin
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: one month after injections of placebo or Botulinum toxin ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Botulinum Toxin: Xeomin
    45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
    Drug: Placebo
    Placebo injection
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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909883

Contacts
Contact: Patrick Lacarin 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
France
CHU Gabriel-Montpied Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Hôpital La Pitié Salpétrière Not yet recruiting
Paris, France, 75651
Hôpital Haut-Levêque Not yet recruiting
Pessac, France, 33600
CHU Purpan Not yet recruiting
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Merz Pharma France
Investigators
Principal Investigator: Franck Durif University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Pr Franck DURIF, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00909883     History of Changes
Other Study ID Numbers: CHU-0051
Study First Received: May 19, 2009
Last Updated: March 24, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Idiopathic Parkinson's disease
Foot (Tiptoe) dystonia
Botulinum Toxin
Muscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Parkinsonian Disorders
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014