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| Name | Class |
|---|---|
| Merz Pharmaceuticals | INDUSTRY |
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).
Study progress :
After an inclusion visit, patients are randomized in one of the 3 following groups :
First group (PL : placebo) :
Second group (ME : Extrinsic muscle)
Third group (MI : Intrinsic muscle)
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin: Xeomin | Drug | 45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study | ||
| Placebo | Drug | Placebo injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lacarin | Contact | 04.73.75.11.95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Franck Durif | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Purpan | Not yet recruiting | Toulouse | Toulouse | 31059 | France | |
| CHU Gabriel-Montpied |
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| Recruiting |
| Clermont-Ferrand |
| 63003 |
| France |
|
| Hôpital La Pitié Salpétrière | Not yet recruiting | Paris | 75651 | France |
| Hôpital Haut-Levêque | Not yet recruiting | Pessac | 33600 | France |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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