Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00291733
Eligibility Criteria:
Inclusion Criteria:
Diagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.
Other inclusion criteria:
* Patients between ages 30 and 80
* Hoehn and Yahr stage of PD over IIb
* Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication
* LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV
* Patient is willing to adhere to protocol requirements as evidence by written informed consent
Exclusion Criteria:
* Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk.
* Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal.
* Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia.
* Patient has a low Mini-mental Examination MMSE score \<25 or has a history of bipolar psychosis or schizophrenia.
* Patient is unwilling to sign an informed consent or to comply with protocol requirements.
* Patient is taking or has taken in the past month amantadine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT00291733
Study Brief:
Protocol Section:
NCT00291733