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

Phase 1

• Conditions: evodopa 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; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-005422-35-GB
• Lead Sponsor: Imperial College London-Imperial College Healthcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-02
• Study Completion: 2017-01-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 8

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified