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Corticosteroid
oral prednisone for Optic Neuritis
Phase 2 & 3
Waitlist Available
Research Sponsored by London Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one and six months
Awards & highlights
Study Summary
Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose corticosteroids are already been chosen by the patient and the diagnosing physician will be contacted for screening and enrollment. Patients will then be randomized to receive equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve function assessments will be compared at baseline, prior to treatment, one and six months post corticosteroid treatment. This will allow for a comparison on whether the route of medication plays a role in the effectiveness of treatment with high dose corticosteroids.
Eligible Conditions
- Optic Neuritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one and six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one and six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
High contrast visual acuity
P100 latency of the Visual Evoked Potential in the affected eye
contrast sensitivity
Side effects data
From 2013 Phase 4 trial • 204 Patients • NCT0063492031%
Urinary tract infection
28%
Oedema peripheral
21%
Nasopharyngitis
15%
Diarrhoea
13%
Blood creatinine increased
12%
Hyperlipidaemia
12%
Anaemia
11%
Gout
11%
Arthralgia
10%
Gingival hyperplasia
10%
Leukopenia
9%
Polyomavirus test positive
9%
Transplant rejection
8%
Hirsutism
8%
Cytomegalovirus infection
8%
Fatigue
8%
Dizziness
8%
Depression
7%
Upper respiratory tract infection
7%
Cough
7%
Herpes zoster
6%
Pneumonia
6%
Gastroenteritis
6%
Headache
5%
Hyperkalaemia
5%
Hypercholesterolaemia
5%
Pyelonephritis
5%
Myalgia
5%
Actinic keratosis
5%
Rash
5%
Lymphocele
4%
Proteinuria
4%
Pain in extremity
4%
Oedema
3%
Urosepsis
3%
Osteoporosis
3%
Dehydration
3%
Squamous cell carcinoma
2%
Hypoglycaemia
2%
Abdominal pain
2%
Cystitis
2%
Sepsis
2%
Toxicity to various agents
2%
Basal cell carcinoma
2%
Hypokalaemia
2%
Erectile dysfunction
2%
Acne
2%
Cholelithiasis
2%
Wound
2%
Chest pain
1%
Hydronephrosis
1%
Epilepsy
1%
Impaired gastric emptying
1%
Diabetic neuropathy
1%
Ventricular fibrillation
1%
Ketoacidosis
1%
Supraventricular tachycardia
1%
Glomerulonephritis rapidly progressive
1%
Encephalitis
1%
Transurethral prostatectomy
1%
Nephrectomy
1%
Diabetic ketoacidosis
1%
Arterial stenosis
1%
Febrile neutropenia
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Atrial fibrillation
1%
Cardiac failure
1%
Polycystic liver disease
1%
Vertigo
1%
Colitis
1%
Diabetic gastroparesis
1%
Pain
1%
Graft versus host disease
1%
Abscess
1%
Acute tonsillitis
1%
Cytomegalovirus gastroenteritis
1%
Erysipelas
1%
Gastroenteritis salmonella
1%
H1N1 influenza
1%
Herpes simplex
1%
Infection
1%
Pyelonephritis acute
1%
Renal cyst infection
1%
Subcutaneous abscess
1%
Femur fracture
1%
Poisoning
1%
Pubis fracture
1%
Rib fracture
1%
Norovirus test positive
1%
Breast cancer
1%
Haemangioma
1%
Non-small cell lung cancer
1%
Parathyroid tumour benign
1%
Cerebrovascular accident
1%
Benign prostatic hyperplasia
1%
Breast enlargement
1%
Dyspnoea
1%
Gastroenteritis caliciviral
1%
Pelvic fracture
1%
BK virus infection
1%
Radius fracture
1%
Osteonecrosis
1%
Bowen's disease
1%
Cerebral haemorrhage
1%
Knee arthroplasty
1%
Manual lymphatic drainage
1%
Oral fungal infection
1%
Hyperparathyroidism
1%
Death
1%
Metaplasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control (CsA)
Everolimus (CNI-free)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: oral prednisoneExperimental Treatment1 Intervention
1250mg oral prednisone daily for 3 days
Group II: IV methylprednisoloneActive Control1 Intervention
1000mg IV methylprednisolone daily for 3 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
FDA approved
Find a Location
Who is running the clinical trial?
London Health Sciences CentreLead Sponsor
143 Previous Clinical Trials
49,911 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
28,376 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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