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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 up to 5 years
Awards & highlights
Approved for 50 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2013 Phase 4 trial • 204 Patients • NCT00634920
31%
Oedema peripheral
29%
Urinary tract infection
24%
Anaemia
17%
Hyperlipidaemia
16%
Nasopharyngitis
15%
Pneumonia
15%
Leukopenia
14%
Proteinuria
14%
Aphthous stomatitis
14%
Acne
13%
Oedema
12%
Diarrhoea
11%
Hypercholesterolaemia
10%
Polyomavirus test positive
10%
Myalgia
10%
Cough
10%
Rash
9%
Osteoporosis
8%
Gastroenteritis
8%
Blood creatinine increased
8%
Hypokalaemia
8%
Headache
7%
Pyrexia
6%
Pain in extremity
6%
Upper respiratory tract infection
6%
Erectile dysfunction
6%
Arthralgia
6%
Oral fungal infection
6%
Wound
5%
Sepsis
5%
Basal cell carcinoma
5%
Cytomegalovirus infection
4%
Urosepsis
4%
Lymphocele
4%
Wound infection
4%
Transplant rejection
4%
Pyelonephritis
4%
Infection
4%
Chest pain
3%
Depression
3%
Atrial fibrillation
3%
Hydronephrosis
3%
Fatigue
3%
General physical health deterioration
2%
Epilepsy
2%
Pneumocystis jiroveci pneumonia
2%
Vomiting
2%
Bronchitis
2%
Herpes zoster
2%
Squamous cell carcinoma
2%
Cerebral haemorrhage
2%
Renal impairment
2%
Infected lymphocele
1%
Renal cyst
1%
Foot fracture
1%
Nephrotic syndrome
1%
Hypoglycaemia
1%
Osteonecrosis
1%
Neck pain
1%
Dysuria
1%
Haematuria
1%
Osteoarthritis
1%
Haematemesis
1%
Graft complication
1%
Hyperglycaemia
1%
Ketoacidosis
1%
Convulsion
1%
Monoparesis
1%
Paraesthesia
1%
Myocardial infarction
1%
Gastritis
1%
Melaena
1%
Thrombosis
1%
Hyperkalaemia
1%
Gangrene
1%
Viral infection
1%
Complications of transplant surgery
1%
Back pain
1%
Gout
1%
Acute myocardial infarction
1%
Cardiac arrest
1%
Cardiac failure
1%
Abdominal hernia
1%
Abdominal pain
1%
Constipation
1%
Pain
1%
Campylobacter infection
1%
Clostridium colitis
1%
Cystitis
1%
Device related infection
1%
Epstein-Barr viraemia
1%
Erysipelas
1%
Gastroenteritis norovirus
1%
Gastroenteritis viral
1%
Lung infection
1%
Rectal abscess
1%
Respiratory tract infection viral
1%
Post-traumatic pain
1%
Postoperative fever
1%
Subdural haematoma
1%
Diabetes mellitus inadequate control
1%
Adenocarcinoma
1%
Small cell lung cancer stage unspecified
1%
Cerebral infarction
1%
Cerebrovascular accident
1%
Cerebrovascular disorder
1%
Nephropathy toxic
1%
Urethral stenosis
1%
Urinary retention
1%
Pulmonary embolism
1%
Vesicoureteral reflux surgery
1%
Deep vein thrombosis
1%
Haematoma
1%
Vena cava thrombosis
1%
Hirsutism
1%
Overdose
1%
Bladder perforation
1%
Dehydration
1%
Lung neoplasm malignant
1%
Gastrointestinal haemorrhage
1%
Joint dislocation
1%
Radius fracture
1%
Post procedural haemorrhage
1%
Chronic myeloid leukaemia
1%
Presyncope
1%
Subarachnoid haemorrhage
1%
Syncope
1%
Dizziness
1%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Everolimus (CNI-free)
Control (CsA)

Awards & Highlights

Approved for 50 Other Conditions
This treatment demonstrated efficacy for 50 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
148 Previous Clinical Trials
57,183 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
28,352 Total Patients Enrolled
~4 spots leftby Dec 2025
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