NCT00909883

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2009

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 25, 2011

Status Verified

March 1, 2011

Enrollment Period

2 years

First QC Date

May 19, 2009

Last Update Submit

March 24, 2011

Conditions

Parkinson's DiseaseFoot Dystonia

Keywords

Idiopathic Parkinson's diseaseFoot (Tiptoe) dystoniaBotulinum ToxinMuscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae

Outcome Measures

Primary Outcomes (1)

  • 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).

    one month after the injection of botulinum toxin/placebo

Secondary Outcomes (1)

  • 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.

    one month after injections of placebo or Botulinum toxin

Interventions

Botulinum Toxin: XeominDRUG

45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study

PlaceboDRUG

Placebo injection

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Purpan

Toulouse, Toulouse, 31059, France

NOT YET RECRUITING

CHU Gabriel-Montpied

Clermont-Ferrand, 63003, France

RECRUITING

Hôpital La Pitié Salpétrière

Paris, 75651, France

NOT YET RECRUITING

Hôpital Haut-Levêque

Pessac, 33600, France

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseDystonia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Franck Durif

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Lacarin

CONTACT

04.73.75.11.95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 29, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2012

Last Updated

March 25, 2011

Record last verified: 2011-03

Locations

FR(4)