Parkinson's DiseasePhase 3RBHP 2008NCT00909883
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)
A Phase 3 study testing Botulinum Toxin: Xeomin in people with Parkinson's Disease and Foot Dystonia, run by University Hospital, Clermont-Ferrand at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease, Foot Dystonia
- What is being tested?
- Botulinum Toxin: Xeomin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2009to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU Gabriel-Montpied
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
- Not yet recruiting
Hôpital La Pitié Salpétrière
Paris, 75651
- Not yet recruiting
Hôpital Haut-Levêque
Pessac, 33600
- Not yet recruiting
CHU Purpan
Toulouse, Toulouse, 31059
About this study
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).
Read the 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).
- Conditions
- Parkinson's Disease, Foot Dystonia
- Being tested
- Botulinum Toxin: Xeomin, Placebo
- Keywords
- Idiopathic Parkinson's disease, Foot (Tiptoe) dystonia, Botulinum Toxin, Muscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae
- Medical subject headings
- Parkinson Disease, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin: XeominDrug
45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
PlaceboDrug
Placebo injection
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: one month after injections of placebo or Botulinum toxin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Investigators
- Franck Durif, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909883
- Sponsor's protocol ID
- CHU-0051
- Acronym
- RBHP 2008
- Status last verified
- Mar 2011
- First submitted
- 19 May 2009
- Last updated
- 25 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00909883
- Acronym / sponsor ID
- RBHP 2008 / CHU-0051
- Conditions
- Parkinson's Disease, Foot Dystonia
- Keywords
- Idiopathic Parkinson's disease, Foot (Tiptoe) dystonia, Botulinum Toxin, Muscles : Flexor digitorum longus/ Flexor digitorum brevis/ quadratus plantae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 29 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin: Xeomin45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study | Drug | – |
| PlaceboPlacebo injection | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck Durif principal investigator
University Hospital, Clermont-Ferrand
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin: Xeomin in people with Parkinson's Disease and Foot Dystonia, run by University Hospital, Clermont-Ferrand at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lacarin (04.73.75.11.95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2011.