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
Recruitment status was Recruiting
Sponsor:
University Hospital, Clermont-Ferrand
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
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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:
Genetics Home Reference related topics:
dopa-responsive dystonia
early-onset primary dystonia
Parkinson disease
Perry syndrome
U.S. FDA Resources
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:
Detailed Description:
-
Drug: Botulinum Toxin: Xeomin
45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
Drug: Placebo
Placebo injection
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
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 Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Botulinum Toxins Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013