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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)

Primary Purpose

Parkinson's Disease, Foot Dystonia

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Botulinum Toxin: Xeomin
Placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Idiopathic Parkinson's disease, Foot (Tiptoe) dystonia, Botulinum Toxin, Muscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Gabriel-MontpiedRecruiting
  • Hôpital La Pitié Salpétrière
  • Hôpital Haut-Levêque
  • CHU Purpan

Outcomes

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).

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.

Full Information

First Posted
May 19, 2009
Last Updated
March 24, 2011
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Merz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00909883
Brief 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)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Merz Pharmaceuticals

4. Oversight

5. Study Description

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 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Foot Dystonia
Keywords
Idiopathic Parkinson's disease, Foot (Tiptoe) dystonia, Botulinum Toxin, Muscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin: Xeomin
Intervention Description
45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injection
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Lacarin
Phone
04.73.75.11.95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Durif
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Gabriel-Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Facility Name
Hôpital La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Haut-Levêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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)

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