Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease (NCT02617017) | Clinical Trial Compass
CompletedPhase 3
Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease
France99 participantsStarted 2016-06-17
Plain-language summary
Parkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor complications that impair quality of life for patients with PD. The mechanisms of these dyskinesias remain unclear, but several hypotheses have been put forward: non continuous, pulsatile stimulation of dopaminergic receptors, or alterations of other neurotransmitters within the motor striatum such as glutamate and serotonin.
Few strategies are now available to treat severe LID:
* Medications: reduction of dopaminergic treatment, addition of amantadine,
* Functional neurosurgery. The purpose of this study is to investigate the efficacy of buspirone in PD patients suffering from dyskinesias. The role of serotonin in the occurrence of LID was recently demonstrated in transplant PD patients and a test double-blind, single dose was achieved. Following administration of 10 mg oral buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of buspirone had already been reported in 1991 and 1994, but identification of buspirone as a serotonin receptor agonist has been reported more recently.
This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial, the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible dose/effect relationship and (4) check the hypothesis of a better therapeutic ratio using the association of buspirone and amantadine instead than a single drug.
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* The subject is an out-patient between 35 year and 80 years of age
* Diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria
* Dyskinesias are present more than 25% of the waking day according to item 4-1 of MDS-UPDRS
* Dyskinesias are at least moderately disabling item 4-2 of MDS-UPDRS replaced by Dyskinesias are at least slightly disabling item 4-2 of MDS-UPDRS (amendment n°2)
* The subject is able to identify dyskinesia, ON and OFF, and apply to his/her own state
* Stable dose of anti-Parkinsonian drugs for at least 4 weeks up to the screening
* The subject is considered as being optimally treated at the time of inclusion
* Written and signed informed consent to participate in the study
* Maximal Hoehn and Yahr staging : III in "ON" phases, IV in "OFF"
* Active affiliation to social security
* Menopausal or under contraception for woman
Exclusion Criteria
* Female subjects : pregnant or lactating
* Atypical parkinsonian syndrome
* Weight less than 40 Kgs
* Mini-Mental State Examination (MMSE) less than 24
* The subject is participating in another clinical study within the past 12 weeks
* Planned participation in another therapeutic clinical study
* Previous treatment with buspirone, less than 6 months before Week 0
* Known allergy to buspirone
* Known lactose intolerance
* Clinically significant illness that might interfere with the study
* Dementia or other psychiatric illnes…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Between-group comparison of changes in UDysRS scores