Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01577992
• Date of registration: 07/11/2011
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Toulouse
• Public title: Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy MSA-DOUL
• Scientific title: Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
• Date of first enrolment: December 2011
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01577992
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Christine Brefel-Courbon, MD
• Affiliation: University Hospital, Toulouse

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients from 50 to 80 years old (Male and female)

- Patients suffering of a diagnosis possible or probable MSA-P with the international
criteria (2008).

- Patients with clinical diagnosis of Parkinson's disease according to the criteria of
the UKPDSBB (Gibb et Lees, 1988; Hughes et al, 1992)

- Patients with no cognitive troubles

- Patients who give their informed and signed consent.

- Patients affiliated to a social protection program

Exclusion Criteria:

- Patient suffering from an other parkinson syndrome than MSA and PD, by example
progressive supranuclear palsy, corticobasal degeneration…

- Patient suffering of a diagnosis possible or probable MSA-C with the international
criteria

- Patient suffering from another pathology causing chronic pain (rheumatic disease,
traumatic or orthopedic pathologies…)

- Patient under tutelage, curatella or law protection



Age minimum: 50 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Pain Threshold

Intervention(s)

Procedure: determination of objective and subjective pain threshold

Drug: Levodopa test

Primary Outcome(s)

Subjective pain threshold [Time Frame: 60 minutes]

Secondary Outcome(s)

Objective nociceptive pain threshold [Time Frame: 15 minutes]

Secondary ID(s)

HAO 2009

0931403

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondation de France