Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease

Phase 3

Completed

• Conditions: Parkinson
• Interventions: Drug: Placebo; Drug: Buspirone

• Registration Number: NCT02617017
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-11-30
• Study Start: 2016-06-17
• Status Verified: 2023-03
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Buspirone	Buspirone	-

Primary Outcome Measures

Name	Time	Method
Between-group comparison of changes in UDysRS scores	Between baseline and week 12

Secondary Outcome Measures

Name	Time	Method
Comparison, in both groups of patients of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3-4 (efficacy)	At week 0,Week2, Week4, Week12, Week13
Comparison, in both groups of patients of side effects (tolerance)	At week Week-2, Week0, Week2, Week4, Week12, Week13
Maximum dose accepted by patients (tolerance)	At week Week-2, Week0, Week2, Week4, Week12, Week13
Comparison, in both groups of patients of MDS-UPDRS part 1-2 (quality of life)	At week Week-2, Week0, Week2, Week4, Week12, Week13
Comparison, in both groups of patients of PDQ-39 (quality of life)	At week 0 and week 12

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France