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Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease (BUSPARK)

Primary Purpose

Parkinson

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Buspirone

Placebo

About this trial

This is an interventional treatment trial for Parkinson focused on measuring Parkinson disease, Levodopa induce dyskinesia

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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 illness
Drug or alcohol abuse replaced by Substance use disorder (alcohol i.e. > 3 drinks per day for men and > 2 drinks per day for women,drug, medicinal product) (amendment n°1)
Legal incapacity or limited legal capacity
Deep brain stimulation performed less than 12 months before protocol initiation, or unstable parameters of stimulation 4 weeks before week 0
Severe renal and / or hepatic impairment
History of seizures or epilepsy

Sites / Locations

Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Buspirone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Between-group comparison of changes in UDysRS scores

Secondary Outcome Measures

Comparison, in both groups of patients of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3-4 (efficacy)

Comparison, in both groups of patients of MDS-UPDRS part 1-2 (quality of life)

Comparison, in both groups of patients of PDQ-39 (quality of life)

Comparison, in both groups of patients of side effects (tolerance)

Maximum dose accepted by patients (tolerance)

Full Information

NCT ID

NCT02617017

First Posted

November 25, 2015

Last Updated

April 11, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02617017

Brief Title

Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease

Acronym

BUSPARK

Official Title

Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease. Multicenter, International, Placebo-controlled, Randomised, Double Blind Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 17, 2016 (Actual)

Primary Completion Date

March 23, 2023 (Actual)

Study Completion Date

March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson

Keywords

Parkinson disease, Levodopa induce dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buspirone

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Buspirone

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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)

Primary Outcome Measure Information:

Title

Between-group comparison of changes in UDysRS scores

Time Frame

Between baseline and week 12

Secondary Outcome Measure Information:

Title

Comparison, in both groups of patients of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3-4 (efficacy)

Time Frame

At week 0,Week2, Week4, Week12, Week13

Title

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, Week13

Title

Comparison, in both groups of patients of PDQ-39 (quality of life)

Time Frame

At week 0 and week 12

Title

Comparison, in both groups of patients of side effects (tolerance)

Time Frame

At week Week-2, Week0, Week2, Week4, Week12, Week13

Title

Maximum dose accepted by patients (tolerance)

Time Frame

At week Week-2, Week0, Week2, Week4, Week12, Week13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 illness Drug or alcohol abuse replaced by Substance use disorder (alcohol i.e. > 3 drinks per day for men and > 2 drinks per day for women,drug, medicinal product) (amendment n°1) Legal incapacity or limited legal capacity Deep brain stimulation performed less than 12 months before protocol initiation, or unstable parameters of stimulation 4 weeks before week 0 Severe renal and / or hepatic impairment History of seizures or epilepsy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Rémy, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Henri Mondor Hospital

City

Creteil

ZIP/Postal Code

94010

Country

France

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Citations:

PubMed Identifier

31356217

Citation

McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.

Results Reference

derived

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Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease

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