ID

43976

Description

A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations; ODM derived from: https://clinicaltrials.gov/show/NCT00360412

Link

https://clinicaltrials.gov/show/NCT00360412

Keywords

Versions (2)
  1. 6/1/17 6/1/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00360412

English

Eligibility Parkinson's Disease NCT00360412

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0030567
UMLS CUI [3]
C2348568
UMLS CUI [4,1]
C0008976
UMLS CUI [4,2]
C0205369
UMLS CUI [4,3]
C0205197
UMLS CUI [5,1]
C1519255
UMLS CUI [5,2]
C0013230
UMLS CUI [5,3]
C0439849
UMLS CUI [6]
C2698764
UMLS CUI [7]
C1513302
UMLS CUI [8]
C1513374
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0021359
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0004764
UMLS CUI [7]
C2985296
UMLS CUI [8,1]
C0430060
UMLS CUI [8,2]
C1513916
UMLS CUI [9,1]
C0430057
UMLS CUI [9,2]
C0106132
UMLS CUI [10]
C0232970
UMLS CUI [11]
C0002453
3. patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per dsm iv criteria.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
4. patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
Description

Feeling suicidal | Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0038663
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.
Description

Psychotic symptom Requirement Antipsychotic drug therapy | Antidepressive Agents Dose Stable | Antipsychotic Agents | Clozapine | quetiapine | Indication Movement Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1319421
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0040615
UMLS CUI [4]
C0009079
UMLS CUI [5]
C0123091
UMLS CUI [6,1]
C3146298
UMLS CUI [6,2]
C0026650
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.
Description

Abnormality Unstable Complicating Investigational New Drugs Assessment | Liver diseases | Kidney Diseases | Cardiovascular Diseases | Respiration Disorders | Gastrointestinal Diseases | Hematological Disease | Endocrine System Diseases | Metabolic Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0231242
UMLS CUI [1,4]
C0013230
UMLS CUI [1,5]
C1516048
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0018939
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0025517
7. patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
Description

Elevated liver enzymes | Elevated total bilirubin | Serum transaminase increased

Data type

boolean

Alias
UMLS CUI [1]
C0235996
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0859350
8. medication known to induce the enzyme cytochrome p450 3a4 is prohibited throughout the study.
Description

Pharmaceutical Preparations Inducing Cytochrome P-450 3A4

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C3714798
9. current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel.
Description

tolcapone | Methyldopa | budipine | Reserpine | Seroquel

Data type

boolean

Alias
UMLS CUI [1]
C0246330
UMLS CUI [2]
C0025741
UMLS CUI [3]
C0054202
UMLS CUI [4]
C0035179
UMLS CUI [5]
C0287163
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0228102
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0679435
UMLS CUI [3,1]
C0030567
UMLS CUI [3,2]
C0015127
UMLS CUI [4]
C3810263
UMLS CUI [5]
C0278138
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0013230
UMLS CUI [6,4]
C0220825
11. patients receiving or with planned (next 12 months) deep brain stimulation.
Description

Deep Brain Stimulation | Deep Brain Stimulation Planned

Data type

boolean

Alias
UMLS CUI [1]
C0394162
UMLS CUI [2,1]
C0394162
UMLS CUI [2,2]
C1301732
12. patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
Description

Condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
13. patients with clinically significant ecg abnormalities, including prolonged qtc (defined as qtc ≥ 450 msec).
Description

ECG abnormality | Prolonged QTc

Data type

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C1969409
14. patients with previous stereotactic surgery (e.g., pallidotomy) for parkinson's disease or with planned stereotactic surgery during the study period.
Description

Stereotactic surgery Parkinson Disease | Pallidotomy | Stereotactic surgery Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1735594
UMLS CUI [1,2]
C0030567
UMLS CUI [2]
C0195893
UMLS CUI [3,1]
C1735594
UMLS CUI [3,2]
C1301732
15. patients on pergolide as of april 5, 2007.
Description

Pergolide

Data type

boolean

Alias
UMLS CUI [1]
C0031007
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Similar models

Eligibility Parkinson's Disease NCT00360412

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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