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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05072015
Other study ID # 8355
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2022
Est. completion date March 2028

Study information

Verified date January 2022
Source University Hospital, Strasbourg, France
Contact Mathieu ANHEIM
Phone +33 3 88 12 85 35
Email mathieu.anheim@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump Secundary purposes: - Motor complications evolution at 6 months, 2 and 3 years - MDS UPDRS III score at 6 months, 1, 2 and 3 years - non motor complications evolution at 6 months, 1, 2 and 3 years - cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years - cutaneous and digestive complications at 6 months, 1, 2 and 3 years - neuropathy occurrence at 6 months, 1, 2 and 3 years - medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date March 2028
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion criteria: - Parkinson disease (UKPDSSB criteria) - Patient with fluctuations and/or dyskinesia , who need treatment with deep brain stimulation, apomorphin pump or duodopa pump - MOCA >20 - patient >21 years of age - patient who has signed protocol acceptation Exclusion criteria: - patient who did not give his acceptation for the protocol - patient with another parkinsonian syndrome than Parkinson' s disease - MOCA<20 - Patient who does not need second line treatment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Mathieu ANHEIM Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement Evaluate the evolution of motor fluctuations and dyskinesias at one year in patients. treated with one of the 3 TSLs (bilateral stimulation of the subthalamic nucleus, apomorphine pump and duodopa pump. the higher the score, the more the disease is installed 1 year
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