ID

23543

Beskrivning

Responsible Party: Prof. Dr. Wolf Lagrèze, Prof. Dr. med., University Eye Hospital, Freiburg ClinicalTrials.gov Identifier: NCT01962571 History of Changes Other Study ID Numbers: P000053 2013-002515-10 ( EudraCT Number ) DRKS00005298 ( Registry Identifier: German Clinical Trials Register (DRKS) ) 01KG1306 ( Other Grant/Funding Number: Federal Ministry of Education and Research ) Study First Received: September 30, 2013 Last Updated: October 24, 2016 Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial (TONE) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01962571

Länk

https://clinicaltrials.gov/ct2/show/NCT01962571

Nyckelord

Versioner (1)
  1. 2017-07-08 2017-07-08 -
Uppladdad den

8 juli 2017

DOI

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Eligibility Optic Neuritis NCT01962571 DRKS00005298

Engelsk

Eligibility Optic Neuritis NCT01962571 DRKS00005298

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Written informed consent obtained according to international guidelines and local laws
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. Male and female patients aged ≥ 18 to ≤ 50 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. Patients with ON
Beskrivning

Optic Neuritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0029134
4. First symptoms of ON ≤ 10 days prior to the first administration of investigational product
Beskrivning

Onset of Symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0277793
5. High contrast visual acuity (HCVA) of ≤ 0.5 (decimal system)
Beskrivning

High contrast visual acuity

Datatyp

boolean

Alias
UMLS CUI [1]
C0042812
6. Adequate OCT measurements available
Beskrivning

OCT measurements

Datatyp

boolean

Alias
UMLS CUI [1]
C0523800
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Beskrivning

Control Group

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
Beskrivning

Capacity

Datatyp

boolean

Alias
UMLS CUI [1]
C1516240
2. Simultaneous participation in another interventional trial which could interfere with this trial and/or participation in a clinical trial within the last 3 months before enrolment in this trial
Beskrivning

Study Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
3. Refractive anomalies: Hyperopia > 5 dpt, myopia < -7 dpt, astigmatism > 3 dpt
Beskrivning

Refractive Errors

Datatyp

boolean

Alias
UMLS CUI [1]
C0034951
4. Media opacity
Beskrivning

Media opacity

Datatyp

boolean

Alias
UMLS CUI [1]
C0010038
5. Severe papillitis
Beskrivning

Papillitis

Datatyp

boolean

Alias
UMLS CUI [1]
C2881208
6. Previous ON
Beskrivning

Previous ON

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0029134
UMLS CUI [1,2]
C0205156
7. Any other optic nerve and retinal disease
Beskrivning

Optic nerve and retinal disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0029132
UMLS CUI [2]
C0035309
8. Pre-existing MS or any other neurological disease
Beskrivning

MS or any other neurological disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0027765
9. Congenital diseases: - thrombophilia - phenylketonuria
Beskrivning

Thrombophilia, phenylketonuria

Datatyp

boolean

Alias
UMLS CUI [1]
C0398623
UMLS CUI [2]
C0031485
10. Acquired diseases: - autoimmune diseases, - cardiovascular diseases, - diabetes mellitus, - uncontrolled hypertension (with blood pressure > 140 / 90 mm Hg (cf. chapter 7.7.5)), - any malignancy, - epilepsy, - known tuberculosis with ongoing or unknown activity, - acute gastrointestinal ulceration within the last 3 months prior to randomisation, - acute viral, bacterial or fungal infection, - known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis C Virus, - history of colitis ulcerosa, diverticulitis, or acute enteroanastomosis, - known osteoporosis, - history of thromboembolic events, - elevated haemoglobin level (>17 g/dl in men or >15 g/dl in women) - polycythaemia - any other significant illness potentially interfering with any trial assessment or trial treatment
Beskrivning

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
11. Performing semi-professional or professional sporting activities or physical training
Beskrivning

Sporting activities

Datatyp

boolean

Alias
UMLS CUI [1]
C0577513
12. Pre-treatment with corticosteroids in the last 30 days prior to the onset of optic neuritis
Beskrivning

Corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
13. Pre-treatment with EPO
Beskrivning

EPO

Datatyp

boolean

Alias
UMLS CUI [1]
C0033567
14. Known or persistent abuse of medication, drugs or alcohol
Beskrivning

Substance Use Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
15. Active immunization within 2 weeks prior to randomisation
Beskrivning

Vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0042196
16. Significant surgery within 4 weeks prior to randomisation
Beskrivning

Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
17. Blood donation or bloodletting within 4 weeks prior to screening
Beskrivning

Blood donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
18. Pre-treatment with immunosuppressive or immunomodulatory agents
Beskrivning

Immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
19. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
Beskrivning

Relationship

Datatyp

boolean

Alias
UMLS CUI [1]
C0015608
This section concerns only female patients who are able to have a child: 20. Current or planned pregnancy; nursing period within 3 months from investigational product administration
Beskrivning

Gynaecological Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
This section concerns only female patients who are able to have a child: 21. Unwillingness to use one of the following safe combination methods of contraception within 3 months from investigational product administration to achieve a PEARL index of <1: female condom, diaphragm or coil, each used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
Beskrivning

Contraceptive Methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
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Similar models

Eligibility Optic Neuritis NCT01962571 DRKS00005298

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
1. Written informed consent obtained according to international guidelines and local laws
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. Male and female patients aged ≥ 18 to ≤ 50 years
boolean
C0001779 (UMLS CUI [1])
Optic Neuritis
Item
3. Patients with ON
boolean
C0029134 (UMLS CUI [1])
Onset of Symptoms
Item
4. First symptoms of ON ≤ 10 days prior to the first administration of investigational product
boolean
C0277793 (UMLS CUI [1])
High contrast visual acuity
Item
5. High contrast visual acuity (HCVA) of ≤ 0.5 (decimal system)
boolean
C0042812 (UMLS CUI [1])
OCT measurements
Item
6. Adequate OCT measurements available
boolean
C0523800 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Capacity
Item
1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
boolean
C1516240 (UMLS CUI [1])
Study Participation Status
Item
2. Simultaneous participation in another interventional trial which could interfere with this trial and/or participation in a clinical trial within the last 3 months before enrolment in this trial
boolean
C2348568 (UMLS CUI [1])
Refractive Errors
Item
3. Refractive anomalies: Hyperopia > 5 dpt, myopia < -7 dpt, astigmatism > 3 dpt
boolean
C0034951 (UMLS CUI [1])
Media opacity
Item
4. Media opacity
boolean
C0010038 (UMLS CUI [1])
Papillitis
Item
5. Severe papillitis
boolean
C2881208 (UMLS CUI [1])
Previous ON
Item
6. Previous ON
boolean
C0029134 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Optic nerve and retinal disease
Item
7. Any other optic nerve and retinal disease
boolean
C0029132 (UMLS CUI [1])
C0035309 (UMLS CUI [2])
MS or any other neurological disease
Item
8. Pre-existing MS or any other neurological disease
boolean
C0026769 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
Thrombophilia, phenylketonuria
Item
9. Congenital diseases: - thrombophilia - phenylketonuria
boolean
C0398623 (UMLS CUI [1])
C0031485 (UMLS CUI [2])
Comorbidity
Item
10. Acquired diseases: - autoimmune diseases, - cardiovascular diseases, - diabetes mellitus, - uncontrolled hypertension (with blood pressure > 140 / 90 mm Hg (cf. chapter 7.7.5)), - any malignancy, - epilepsy, - known tuberculosis with ongoing or unknown activity, - acute gastrointestinal ulceration within the last 3 months prior to randomisation, - acute viral, bacterial or fungal infection, - known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis C Virus, - history of colitis ulcerosa, diverticulitis, or acute enteroanastomosis, - known osteoporosis, - history of thromboembolic events, - elevated haemoglobin level (>17 g/dl in men or >15 g/dl in women) - polycythaemia - any other significant illness potentially interfering with any trial assessment or trial treatment
boolean
C0009488 (UMLS CUI [1])
Sporting activities
Item
11. Performing semi-professional or professional sporting activities or physical training
boolean
C0577513 (UMLS CUI [1])
Corticosteroids
Item
12. Pre-treatment with corticosteroids in the last 30 days prior to the onset of optic neuritis
boolean
C0001617 (UMLS CUI [1])
EPO
Item
13. Pre-treatment with EPO
boolean
C0033567 (UMLS CUI [1])
Substance Use Disorder
Item
14. Known or persistent abuse of medication, drugs or alcohol
boolean
C0038586 (UMLS CUI [1])
Vaccination
Item
15. Active immunization within 2 weeks prior to randomisation
boolean
C0042196 (UMLS CUI [1])
Surgery
Item
16. Significant surgery within 4 weeks prior to randomisation
boolean
C0543467 (UMLS CUI [1])
Blood donation
Item
17. Blood donation or bloodletting within 4 weeks prior to screening
boolean
C0005794 (UMLS CUI [1])
Immunosuppression
Item
18. Pre-treatment with immunosuppressive or immunomodulatory agents
boolean
C0021079 (UMLS CUI [1])
Relationship
Item
19. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
boolean
C0015608 (UMLS CUI [1])
Gynaecological Status
Item
This section concerns only female patients who are able to have a child: 20. Current or planned pregnancy; nursing period within 3 months from investigational product administration
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive Methods
Item
This section concerns only female patients who are able to have a child: 21. Unwillingness to use one of the following safe combination methods of contraception within 3 months from investigational product administration to achieve a PEARL index of <1: female condom, diaphragm or coil, each used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
boolean
C0700589 (UMLS CUI [1])
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