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The role of striatal serotonergic terminals in L-dopa induced-dyskinesia in Parkinson's disease patients: An in vivo Positron emission tomography (PET) study

The role of striatal serotonergic terminals in L-dopa induced-dyskinesia in Parkinson's disease patients: a proof of concept study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN03683971
Enrollment
300
Registered
2012-07-31
Start date
2008-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease Nervous System Diseases Parkinson's disease

Interventions

Open label use of buspirone together with L-dopa in an aim to alleviate dyskinesias and to study the role of serotonergic terminals in L-dopa induced dyskinesia with PET. Visit 1: Patients will take

Sponsors

Imperial College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Parkinson's disease patients and healthy individuals Parkinson's disease patients 1. Age between 50-80 2. Were diagnosed with PD according to the UK PD Society Brain Bank criteria (Hughes et al., 1992) 3. On L-dopa treatment during the time of the study 4. Responsive to L-dopa with more than 25% reductions in Unified PD Rating Scale (UPDRS) part III motor scores 5. More than 6 months on L-DOPA 6. Non-demented [mini?mental state examination (MMSE = 26] 7. No psychiatric disorders as screened with a structured clinical interview for DSM-IV Axis I Disorders (SCID-I) 8. Do not fail screening for depression [Beck Depression Inventory - II (BDI-II) < 17; Hamilton Rating Scale for Depression (HRSD) < 14] 9. None of the subjects had received anti-depressant therapy in the past or any other medication with known action on the serotonergic system 10. No more than 1.5 body mass index (BMI) units changes over the last 12 months Healthy individuals 1. Age between 50-80 2. Non-demented (MMSE = 26) 3. No psychiatric disorders as screened with a structured clinical interview for DSM-IV Axis I Disorders (SCID-I) 4. Do not fail screening for depression (BDI-II < 17; HRSD < 14) 5. None of the subjects had received anti-depressant therapy in the past or any other medication with known action on the serotonergic system 6. No more than 1.5 BMI units changes over the last 12 months 7. Were not on any medication 8. No previous history of neurological or psychiatric illness

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Dyskinesias assesments with Abnormal Involuntary Movement Scale (AIMS) 2. Reduction of abnormal dopamine release in the striatum of Parkinson's disease patients as measured with PET Measured 150 minutes following administration of medication.

Secondary

MeasureTime frame
Changes in motor function as measured with Unified Parkinson's Disease Rating Scale (UPDRS) part III motor scale measured 150 minutes following administration of medication.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026