The role of Buspirone in attenuating involuntary movements (Dyskinesias) in patients with Parkinson's disease.

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2014-005422-35-GB
• Date of registration: 02/04/2015
• Prospective Registration: Yes
• Primary sponsor: Imperial College London-Imperial College Healthcare NHS Trust
• Public title: The role of Buspirone in attenuating involuntary movements (Dyskinesias) in patients with Parkinson's disease.
• Scientific title: THE ROLE OF BUSPIRONE IN ATTENUATING LEVODOPA-INDUCED DYSKINESIAS IN PATIENTS WITH PARKINSON'S DISEASE: A CLINICAL AND POSITRON EMISSION TOMOGRAPHY STUDY WITH 11C-PHNO. - The role of buspirone in LIDs in patients with Parkinson’s disease.
• Date of first enrolment: 28/05/2015
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005422-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Paola Piccini
• Affiliation: Imperial College London - Imperial College NHS Trust

• Name: Paola Piccini
• Affiliation: Imperial College London - Imperial College NHS Trust

Key inclusion & exclusion criteria

Inclusion criteria:
The inclusion/exclusion criteria include non-depressed, non-demented PD subjects with no other history of neurological or psychiatric illness and who are not receiving any medication with known direct action on the 5-HT system.
All patients will have a clinical diagnosis of idiopathic Parkinson's disease according to UK Parkinson's Disease Society Brain Bank diagnostic criteria.
The participants will be people above the age of 40 and under the age of 80.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion criteria:
Subjects that have developed dementia and/or Parkinson plus syndromes.
Subjects with depression and/or anxiety disorders history will be excluded.
Subjects with epilepsy and/or other neurological conditions will be excluded.
Subjects with acute porphyria history will be excluded.
Subjects that are receiving medication with known action on the 5-HT system.
Subjects with a clinical history that Buspirone is contraindicated.
Subject with a clinical history of acute intoxication with alcohol, hypnotics, analgesics, or antipsychotic drugs.
Patients with severe renal or hepatic impairment.
Women of child bearing potential will be provided with a beta human chorionic gonadotropin (b-HCG) pregnancy test (by urine dipstick method) on each visit prior to the administration of the Buspirone. An additional urine b-HCG pregnancy test will be performed on each PET visit. Positive results of this b-HCG test exclude potential participants from this study.
Pregnant and breast feeding women are excluded from this study.
Patients who recently took part in clinical studies or underwent medical procedures involving ionizing radiation will be excluded from participation in the PET part of the study if participation will lead to an ionising radiation exposure >10mSv in the past 12 months.
Patients found to have contraindications to having an MRI scan (e.g, claustrophobia, metal implants).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Levodopa induced dyskinesias within Parkinson's disease.
MedDRA version: 17.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Buspirone Hydrochloride
Product Name: Buspirone Hydrochloride
Pharmaceutical Form: Tablet
INN or Proposed INN: Buspirone Hydrochloride
Concentration type: equal
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To demonstrate that buspirone which is a serotonine (5HT1A) antagonist will reduce the levels of synaptic dopamine generated from the serotonergic terminals after L-dopa administration. This will be associated with a reduction in dyskinesia intensity in PD patients.

Primary end point(s): We will assess/measure whether the severity of Levodopa-induced dyskinesias improves by the administration of Buspirone prior to Levodopa and we will compare this to placebo.
We anticipate that Buspirone will be efficient in attenuating the Levodopa-induced dyskinesias in Parkinson's disease patients without counteracting Levodopa's main effects.

Secondary Objective: To elucidate more the role of dysregulated DA transmission from striatum for groups of patients with PD with different degrees of severity in LIDs through analysis with data already gained from our previous studies. This will be confirmed by functional Imaging with PET and 11C-PHNO targeting postsynaptic D2/3 receptors on a Buspirone+Levodopa vs Placebo+Levodopa acute challenge.

Secondary ID(s)

14HH2382

139087

Source(s) of Monetary Support

The Michael J Fox Foundation for Parkinson's Research

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 12/10/2018
• Date Completed: 23/01/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-005422-35/results