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

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ClinicalTrials.gov Identifier: NCT02617017
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Parkinson Drug: Buspirone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buspirone Drug: Buspirone
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 Drug: 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)




Primary Outcome Measures :
  1. Between-group comparison of changes in UDysRS scores [ Time Frame: Between baseline and week 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Comparison, in both groups of patients of PDQ-39 (quality of life) [ Time Frame: At week 0 et week 12 ]
  4. Comparison, in both groups of patients of side effects (tolerance) [ Time Frame: At week Week-2, Week0, Week2, Week4, Week12, Week13 ]
  5. Maximum dose accepted by patients (tolerance) [ Time Frame: At week Week-2, Week0, Week2, Week4, Week12, Week13 ]


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Gilles Fénelon, MD (0)1 49 81 23 02 ext +33 gilles.fenelon@aphp.fr
Contact: Florence Couppey, CRA (0)1 49 81 37 52 ext +33 florence.couppey@aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Gilles Fénelon, MD    (0)1 49 81 23 02 ext +33    gilles.fenelon@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Gilles Fénelon, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02617017     History of Changes
Other Study ID Numbers: P130909
2015-002332-41 ( EudraCT Number )
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parkinson disease
Levodopa induce dyskinesia

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action