Informações:
Falhas:
ID
43789
Descrição
An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications; ODM derived from: https://clinicaltrials.gov/show/NCT02082249
Link
https://clinicaltrials.gov/show/NCT02082249
Palavras-chave
Versões (2)
- 01/05/2016 01/05/2016 -
- 20/09/2021 20/09/2021 -
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Advanced Parkinson's Disease NCT02082249
Eligibility Advanced Parkinson's Disease NCT02082249
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Parkinson's Disease NCT02082249
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Carbidopa / Levodopa
Item
subjects completing 12 weeks treatment in study m12-921 who would benefit from long-term treatment from abt-slv187. alternatively, subjects who (i) participated in the phase 2 study m12-925 (ii) would, in the opinion of the investigator, benefit from abt-slv187 treatment in the study m12-923, (iii) did not discontinue the m12-925 study due to safety reason, and (iv) meet all entry requirements.
boolean
C0353697 (UMLS CUI [1])
informed consent
Item
the subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
boolean
C0021430 (UMLS CUI [1])
Previous treatment continue
Item
the subject must be willing to continue on treatment.
boolean
C0420262 (UMLS CUI [1])
subject is enrolled in another clinical trial
Item
subject is enrolled in another clinical trial
boolean
C2348568 (UMLS CUI [1])
interfere with patient
Item
psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
boolean
C0525058 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0525058 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
contraindication to continued levodopa therapy
Item
medical, laboratory, or surgical issues deemed by the investigator to be clinically significant and in the opinion of the pi, would be a contraindication to continued levodopa therapy.
boolean
C1301624 (UMLS CUI [1])
C0023570 (UMLS CUI [2])
C0023570 (UMLS CUI [2])
Patient Non-Compliance
Item
uncooperative attitude or reasonable likelihood for non-compliance with the protocol
boolean
C0376405 (UMLS CUI [1])
suicidal ideation
Item
subject has current significant suicidal ideation as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the columbia-suicide severity rating scale completed at the week 12 visit of study m12-921 or at the baseline visit of the current study for m12-925 study subjects.
boolean
C0424000 (UMLS CUI [1])
unsuitable candidate to continue to receive
Item
consideration by the investigator, for any reason, that the subject is an unsuitable candidate to continue to receive abt-slv187
boolean
C3839545 (UMLS CUI [1,1])
C2002915 (UMLS CUI [1,2])
C2002915 (UMLS CUI [1,2])