A Phase 3 interventional study of Injection of Dysport then placebo and Injection of placebo then Dysport in PARKINSON DISEASE (Disorder), sponsored by University Hospital, Toulouse. Not yet recruiting at 2 sites in France. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University Hospital, Toulouse · Phase 3, Interventional, and Treatment
Among 33 studies in Parkinson Disease by University Hospital, Toulouse — 7 open to participants now, 7 under way, 1 of them phase 3. Parkinson Disease · University Hospital, Toulouse.
Among the 33 studies in Parkinson Disease by University Hospital, Toulouse, this one is the 12th largest by planned enrollment of the 25 interventional ones that give a count, is one of 3 that started in 2026, is one of 2 in phase 3, and was the 33rd registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
Browse Parkinson Disease studies →7 of the 33 studies in Parkinson Disease by University Hospital, Toulouse are open now, in 4 countries. Recruiting first, the newest first:
University Hospital, Toulouse · Sites in France
University Hospital, Toulouse · Sites in France
University Hospital, Toulouse · Sites in France
University Hospital, Toulouse · Sites in France, Germany, Spain and 1 more country
University Hospital, Toulouse · Sites in France
By country, each count listing its studies:
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 6 · Phase 3 3 · Phase 4 1
First in 2002; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 39 is close to the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Median enrollment 38 across the 25 interventional studies, 81 across the 8 observational. Of the 24 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
3 of the studies in Parkinson Disease by University Hospital, Toulouse that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07189468University Hospital, ToulouseAI-based Progression and Medication Response Prediction Study in Parkinson's Disease | 2027-04-01 |
| NCT06885541University Hospital, ToulouseDetection of Internal Tremors by Oscillometry in Parkinson's Patient | 2027-05-10 |
| NCT07578272University Hospital, ToulousePrevention of Medical, Social, and Psychosocial Risks Following a Parkinson's Disease Diagnosis: A Pilot Study | 2027-09-30 |
Among the 33 studies in Parkinson Disease by University Hospital, Toulouse, from their registry updates:
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Tremor is one of the most common symptoms in Parkinson Disease (PD), affecting almost 60% of patients. There is currently no specific treatment for tremor in PD, and 30% of patients develop drug-resistant tremor, making its management more complex. Botulinum toxin (BT) is widely used in neurology, but few studies have been carried out on the effect of BT in parkinsonian tremor without consensus on its management in parkinsonian patients. In this study, the investigators therefore propose to evaluate the effect of BT injected using precision medicine in the treatment of refractory resting tremor in patients with PD, compared with placebo injection.
Parkinson's disease (PD) is the second most common neurodegenerative disease. Tremor is one of the most common symptoms, affecting almost 60% of patients. It has a considerable impact on their quality of life, causing psychosocial stress in over 25% of patients. There is currently no specific treatment for tremor in PD, and 30% of patients develop drug-resistant tremor, making its management more complex. Botulinum toxin (BT) has been approved in France in 1994 and is widely used in neurology. To date, few studies have been carried out on the effect of BT in parkinsonian tremor: most have been open-label and have mixed parkinsonian patients and patients with essential tremor. Therefore, there is no consensus on the management of tremor in patients with PD. Nevertheless, there is a real need for treatment of refractory tremor, particularly in elderly patients, patients who cannot tolerate high doses of medication or patients who are ineligible for neurostimulation. In this study, the investigators therefore propose to evaluate the effect of BT injected using precision medicine in the treatment of refractory resting tremor in parkinsonian patients, compared with placebo injection. The investigators hypothesize that BT treatment improves parkinsonian tremor in a clinically relevant way compared to placebo injection using an optimized and personalized injection technique (doses of toxin and muscles injected). The drug will be injected intramuscularly into the muscles identified as responsible for the tremor, by an investigator specialising in injections. PD patients with resistant tremor will be included and followed up in this study for one year. BT or placebo will be injected at 6 months apart in all patients thanks to the cross over study design.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this cross-over study, the patient will be his or her own control. The patient will receive both treatments at 6 months apart: DYSPORT followed by the placebo (the order of injections has been randomly assigned).
Drug: Injection of Dysport then placebo
In this cross-over study, the patient will be his or her own control. The patient will receive both treatments at 6 months apart: placebo followed by DYSPORT (the order of injections has been randomly assigned).
Drug: Injection of placebo then Dysport
Both treatments, first DYSPORT 500UI for 6 months then placebo, also for 6 months, will be administered intramuscularly using the same schedule and procedures thus allowing the blind to be maintained. The two injections will be carried at 6 months apart: the drug will be injected intramuscularly, into the muscles identified as responsible for the tremor, by an investigator specialized in carrying out injections. The doses injected will depend on the severity of the tremor and the number of muscles injected, which is conditioned by the tremor phenotype.
Both treatments, first placebo for 6 months then DYSPORT 500UI, also for 6 months, will be administered intramuscularly using the same schedule and procedures thus allowing the blind to be maintained. The two injections will be carried at 6 months apart: the drug will be injected intramuscularly, into the muscles identified as responsible for the tremor, by an investigator specialized in carrying out injections. The doses injected will depend on the severity of the tremor and the number of muscles injected, which is conditioned by the tremor phenotype.
The effect of botulinum toxin on the resting tremor of the upper limb refractory to treatments
It will be assessed by the PGI-C (Patient Global Impression-Change) score completed by the patient six weeks after injection and compared between treatments.
Time frame: 7,5 months
The effect of botulinum toxin on the resting tremor: evolution evaluated by the investigator
It will be assessed by the CGI-C (Clinician Global Impression-Change) investigator-level change score, six weeks after injection.
Time frame: 7,5 months
The effect of botulinum toxin on the resting tremor: severity evaluated by the investigator
It will be assessed by the delta of severity scores at the CGI-S (Clinician Global Impression-Severity) investigator level between injection and six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the resting tremor: amplitude evaluated by the investigator
It will be assessed by the delta of the item score 3.17 (amplitude) at the MDS-UPDRS III investigator level between injection and six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the resting tremor: patient-assessed severity
It will be assessed by the delta of severity scores at the patient scale PGI-S (Patient Global Impression-Severity) between injection and six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the postural tremor: evolution evaluated by the investigator
It will be assessed by the change score at the CGI-C investigator scale, at six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the postural tremor: severity evaluated by the investigator
It will be assessed by the delta of severity scores at the CGI-S investigator level between injection and six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the postural tremor: amplitude evaluated by the investigator
It will be assessed by the delta of item 3.21 (amplitude) at the MDS-UPDRS III investigator level between injection and six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the postural tremor: patient-assessed change
It will be assessed by the PGI-C scale score completed by the patient six weeks after injection and compared between groups.
Time frame: 7,5 months
The effect of botulinum toxin on the postural tremor: patient-assessed severity
It will be assessed by the delta of severity scores on the PGI-S (Patient Global Impression-Severity) scale completed by the patient between the injection and six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): duration
It will be assessed by the proportion of time the patient has a tremor, measured using an actimeter for 7 days prior to the assessment visit.
Time frame: 12 months
The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): amplitude
It will be assessed by the mean angular amplitude measured using motion sensors placed on the hand and arm at six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): frequency
It will be assessed by the mean frequency in Hertz (Hz) measured using motion sensors placed on the hand and arm at six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the patient's experience: life quality
It will be assessed by the delta of the patient's quality of life score on the PDQ-39 self-administered questionnaire between injection and six weeks post-injection.
Time frame: 7,5 months
The effect of botulinum toxin on the patient's experience: daily life activities
It will be assessed by the delta of the daily life activities score by the MDS-UPDRS scale, parts one and two between injection and six weeks post-injection.
Time frame: 7,5 months
The safety of use for botulinum toxin: muscle weakness (1)
It will be assessed by the delta of the measurement in Newton of the manual dynamometer, for the treated hand, between injection and six weeks after injection.
Time frame: 7,5 months
The safety of use for botulinum toxin: muscle weakness (2)
It will be assessed by the delta of the severity scores for muscle weakness in the treated hand, on the PGI-S (Patient Global Impression Severity) scale, completed by the patient between the injection and six weeks after the injection.
Time frame: 7,5 months
The safety of use for botulinum toxin: adverse events
It will be assessed by all the adverse events collected during the study.
Time frame: 12 months
The factors associated with good response to botulinum toxin treatment
The correct response to treatment will be determined from the scores of the PGI-S patient scale on the severity of the tremor and on the severity of the muscle weakness.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
Of 67 phase 3 interventional studies under Parkinson Disease, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 36 months is close to that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Oct 2026 → Dec 2026, primary completion Oct 2029 → Dec 2029 and completion Oct 2029 → Dec 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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