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Dopaminergic Loss and Pain in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00940914
First received: July 16, 2009
Last updated: March 29, 2011
Last verified: March 2011
History of Changes
  Purpose

About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain threshold, the investigators will establish correlations between dopaminergic degeneration and pain perception.


Condition Intervention Phase
Parkinson's Disease
Pain
 Drug: ioflupane 123I (DATSCAN®)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Single photon emission computerized tomography (SPECT) will be used to evaluate binding of 123I FP-CIT to dopamine transporters. This exam will allow calculation of the ratio of specific to non specific binding of 123I FP-CIT to dopamine transporters. [ Time Frame: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT. ] [ Designated as safety issue: No ]
  • Pain perception will be evaluated by the determination of subjective pain thresholds (thermal pain thresholds, thermotest). A thermode will be used to determine the heat and cold pain thresholds. [ Time Frame: Image acquisition (SPECT) will be performed after three hours post-injection of 123I FP-CIT. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of Parkinson's disease will be evaluated with the Unified Parkinson's disease Rating Scale (UPDRS) and the Hoehn and Yahr scale [ Time Frame: Evaluation will be done within three hours before image acquisition (SPECT). ] [ Designated as safety issue: No ]
  • Short French version of McGill pain questionnaire (MPQ). [ Time Frame: Evaluation will be done within three hours before image acquisition (SPECT). ] [ Designated as safety issue: No ]
  • Pain intensity will be assessed using a 10 cm visual analogue scale (VAS) (0 = no pain; 10 = worst possible pain). [ Time Frame: Evaluation will be done within three hours before image acquisition (SPECT). ] [ Designated as safety issue: No ]
  • DN4 scale [ Time Frame: Evaluation will be done within three hours before image acquisition (SPECT). ] [ Designated as safety issue: No ]
  • Brief Inventory Pain [ Time Frame: Evaluation will be done within three hours before image acquisition (SPECT). ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression (HAD) scale [ Time Frame: Evaluation will be done within three hours before image acquisition (SPECT). ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2009
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
pain disorders
patients with Parkinson's disease presenting pain disorders
 Drug: ioflupane 123I (DATSCAN®)
One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
Other Names:
  • - N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane
  • - FP-CIT
without pain disorders
patients with Parkinson's disease without pain disorders
 Drug: ioflupane 123I (DATSCAN®)
One administration (2,5 ml) of ioflupane 123I 0,07-0,13 µg/ml; 74 MBq/ml; IV (in the vein)
Other Names:
  • - N-w-fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl)tropane
  • - FP-CIT

Detailed Description:

Parkinson's disease is a frequent neurodegenerative disease leading to motor handicap, cognitive and pain disorders. These pain disorders could be correlated to dopaminergic loss.

The clinical trial will be conducted in a single center (Neurology Department, Purpan Hospital, Toulouse, France). The study is classified as a physiopathology one. Twenty patients with Parkinson's disease, presenting pain disorders or not, will be selected. This clinical trial will last one year. All the exams, including image acquisition will be done the same day. These will take about 6 hours for each patient.

Expected results: Binding of 123I FP-CIT to dopamine transporters should negatively correlate with pain intensity and also with thermal pain thresholds in patients suffering from Parkinson's disease.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinically established Parkinson's disease according to the UKPDSBB (UK Parkinson's Disease Society Brain Bank) (Gibb et Less, 1998; Hugues et al, 1992).
  • Male or Female patients, aged from 30 to 70 years.
  • Patients must benefit from the French Social security system.
  • Patients must give a written informed consent.
  • Female fertile patients must use an efficient method of contraception.

If patients suffer from chronic pain, pain must be related to Parkinson's disease.

Exclusion Criteria:

  • Patients with a syndrome other than the idiopathic Parkinson's disease.
  • Patients suffering from important trembling during the OFF periods or abnormal involuntary movements (dyskinesia) during the ON periods, not allowing the imagery exam to be performed.
  • Patients suffering from another disease causing chronic pain.
  • Patients suffering from cancer.
  • Patients with cognitive dysfunction.
  • Patients not able to complete the scales.
  • Pregnant, breastfeeding or fertile female patients not using an efficient method of contraception.
  • Patients not willing to participle in the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940914

Locations
France
University Hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Christine Brefel-Courbon, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: Elodie Lestimé, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00940914     History of Changes
Other Study ID Numbers: 0730302, AOL 2007
Study First Received: July 16, 2009
Last Updated: March 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Parkinson's disease
pain
dopamine transporters imaging

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 21, 2013