Gender | Parkinson Disease | Study Subject Participation Status | Clinical Trial Specified Completed | Serious Adverse Event Investigational New Drug Related | E2007 | Mild Adverse Event | Moderate Adverse Event
Item
male or female patients with idiopathic pd who have fulfilled the entry criteria to either e2007-e044-301 or e2007-a001-302 and have completed that study up to and including the final efficacy visit. patients will not be eligible if they withdrew from the core study prior to the final efficacy visit for any reason including lack of efficacy. patients with saes which are ongoing or possibly or probably related to the study drug, will not be eligible for this study. patients with ongoing adverse events categorized as severe and thought to be related to e2007 should not be entered. patients with mild or moderate adverse events thought to be related to e2007 can be entered to the study if the investigator considers it safe.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C0008976 (UMLS CUI [4,1])
C0205369 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C1519255 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
C2698764 (UMLS CUI [6])
C1513302 (UMLS CUI [7])
C1513374 (UMLS CUI [8])
Pregnancy | Breast Feeding
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Infertility | Female Sterilization | Sexual Abstinence | Intrauterine Devices | Contraception, Barrier | Hormonal contraception | Serum pregnancy test (B-HCG) Negative | Urine pregnancy test negative Human Chorionic Gonadotropin, beta | Postmenopausal state | Amenorrhea
Item
2. women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, iud or barrier method plus hormonal method). these patients must have a negative serum or urine b-hcg test at their first study visit. these patients must also be willing to remain on their current form of contraception for the duration of the study. postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential as determined by the investigator.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0021359 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C2985296 (UMLS CUI [7])
C0430060 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C0430057 (UMLS CUI [9,1])
C0106132 (UMLS CUI [9,2])
C0232970 (UMLS CUI [10])
C0002453 (UMLS CUI [11])
Substance Use Disorders
Item
3. patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per dsm iv criteria.
boolean
C0038586 (UMLS CUI [1])
Feeling suicidal | Suicide attempt
Item
4. patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
boolean
C0424000 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
Psychotic symptom Requirement Antipsychotic drug therapy | Antidepressive Agents Dose Stable | Antipsychotic Agents | Clozapine | quetiapine | Indication Movement Disorders
Item
5. patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. patients may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to the baseline visit. use of anti-psychotic medication including clozapine and quetiapine is prohibited even if the indication is for movement disorders.
boolean
C0871189 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1319421 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3])
C0009079 (UMLS CUI [4])
C0123091 (UMLS CUI [5])
C3146298 (UMLS CUI [6,1])
C0026650 (UMLS CUI [6,2])
Abnormality Unstable Complicating Investigational New Drugs Assessment | Liver diseases | Kidney Diseases | Cardiovascular Diseases | Respiration Disorders | Gastrointestinal Diseases | Hematological Disease | Endocrine System Diseases | Metabolic Diseases
Item
6. patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
boolean
C1704258 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0231242 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C1516048 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
Elevated liver enzymes | Elevated total bilirubin | Serum transaminase increased
Item
7. patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
boolean
C0235996 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0859350 (UMLS CUI [3])
Pharmaceutical Preparations Inducing Cytochrome P-450 3A4
Item
8. medication known to induce the enzyme cytochrome p450 3a4 is prohibited throughout the study.
boolean
C0013227 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C3714798 (UMLS CUI [1,3])
tolcapone | Methyldopa | budipine | Reserpine | Seroquel
Item
9. current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel.
boolean
C0246330 (UMLS CUI [1])
C0025741 (UMLS CUI [2])
C0054202 (UMLS CUI [3])
C0035179 (UMLS CUI [4])
C0287163 (UMLS CUI [5])
Condition Affecting Peripheral sensory structure | Condition At risk Central sensory disorder | Parkinson Disease Etiology aspects | Mild sensory impairment | Mild pain | Condition Interferes with Investigational New Drugs Evaluation
Item
10. patients with conditions affecting the peripheral or central sensory system unless related to parkinson's disease (such as mild sensory or pain syndromes limited to off periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0228102 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0679435 (UMLS CUI [2,3])
C0030567 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C3810263 (UMLS CUI [4])
C0278138 (UMLS CUI [5])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0013230 (UMLS CUI [6,3])
C0220825 (UMLS CUI [6,4])
Deep Brain Stimulation | Deep Brain Stimulation Planned
Item
11. patients receiving or with planned (next 12 months) deep brain stimulation.
boolean
C0394162 (UMLS CUI [1])
C0394162 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Condition Study Subject Participation Status Inappropriate
Item
12. patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
ECG abnormality | Prolonged QTc
Item
13. patients with clinically significant ecg abnormalities, including prolonged qtc (defined as qtc ≥ 450 msec).
boolean
C0522055 (UMLS CUI [1])
C1969409 (UMLS CUI [2])
Stereotactic surgery Parkinson Disease | Pallidotomy | Stereotactic surgery Planned
Item
14. patients with previous stereotactic surgery (e.g., pallidotomy) for parkinson's disease or with planned stereotactic surgery during the study period.
boolean
C1735594 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0195893 (UMLS CUI [2])
C1735594 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Pergolide
Item
15. patients on pergolide as of april 5, 2007.
boolean
C0031007 (UMLS CUI [1])