Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease (BUSPARK)
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|ClinicalTrials.gov Identifier: NCT02617017|
Recruitment Status : Unknown
Verified February 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : November 30, 2015
Last Update Posted : February 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson||Drug: Buspirone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease. Multicenter, International, Placebo-controlled, Randomised, Double Blind Trial|
|Actual Study Start Date :||June 17, 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Capsules of buspirone will be administered orally once a day for 2 weeks (10mg, morning), BID for 2 further weeks (20 mg, morning and evening), TID between weeks 5 and 12 (third intake at noon)
|Placebo Comparator: Placebo||
Capsules of placebo will be administered orally once a day for 2 weeks (10mg, morning), BID for 2 further weeks (20 mg, morning and evening), TID between weeks 5 and 12 (third intake at noon)
- Between-group comparison of changes in UDysRS scores [ Time Frame: Between baseline and week 12 ]
- Comparison, in both groups of patients of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3-4 (efficacy) [ Time Frame: At week 2,Week0, Week4, Week12, Week13 ]
- Comparison, in both groups of patients of MDS-UPDRS part 1-2 (quality of life) [ Time Frame: At week Week-2, Week0, Week2, Week4, Week12, Week1 ]
- Comparison, in both groups of patients of PDQ-39 (quality of life) [ Time Frame: At week 0 et week 12 ]
- Comparison, in both groups of patients of side effects (tolerance) [ Time Frame: At week Week-2, Week0, Week2, Week4, Week12, Week13 ]
- Maximum dose accepted by patients (tolerance) [ Time Frame: At week Week-2, Week0, Week2, Week4, Week12, Week13 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617017
|Contact: Gilles Fénelon, MD||(0)1 49 81 23 02 ext +firstname.lastname@example.org|
|Contact: Florence Couppey, CRA||(0)1 49 81 37 52 ext +email@example.com|
|Henri Mondor Hospital||Recruiting|
|Creteil, France, 94010|
|Contact: Gilles Fénelon, MD (0)1 49 81 23 02 ext +33 firstname.lastname@example.org|
|Principal Investigator:||Gilles Fénelon, MD||Assistance Publique - Hôpitaux de Paris|