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Antioxidant

1 for Leber Optic Neuropathy (RHODOS Trial)

Phase 2
Waitlist Available
Led By Prof Thomas Klopstock, MD
Research Sponsored by Santhera Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved

Summary

This study is meant to assess the effectiveness of idebenone on visual function measures in patients with Leber's Hereditary Optic Neuropathy over a 6 months period.

Eligible Conditions
  • Leber Optic Neuropathy

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 2021 Phase 4 trial • 199 Patients • NCT02774005
34%
Total
19%
Headache
17%
Nasopharyngitis
10%
Diarrhoea
8%
Nausea
8%
Alanine aminotransferase increased
7%
Oropharyngeal pain
7%
Aspartate aminotransferase increased
7%
Abdominal pain upper
7%
Blood creatine phosphokinase increased
6%
Cough
5%
Gamma-glutamyltransferase increased
5%
Back pain
4%
Influenza
4%
Toothache
4%
Fatigue
4%
Sinusitis
4%
Abdominal pain
4%
Depression
3%
Eye pain
3%
Dyspepsia
3%
Upper respiratory tract infection
3%
Visual impairment
3%
Rash
3%
Vomiting
3%
Malaise
3%
Blood triglycerides increased
3%
Pyrexia
2%
Urine abnormality
2%
Seasonal allergy
2%
Lower respiratory tract infection
2%
Urinary tract infection
2%
Anxiety
2%
Blood cholesterol increased
2%
Bacterial test positive
2%
Gastroenteritis viral
2%
Myalgia
2%
Suicide attempt
2%
Neutrophil count decreased
2%
Ear pain
2%
Bronchitis
2%
Gastroenteritis
2%
Blood alkaline phosphatase increased
2%
Blood bilirubin increased
2%
Lymphocyte count increased
2%
Neutrophil count increased
2%
Chromaturia
2%
Hypertension
2%
Dizziness
2%
Influenza like illness
2%
Pain
2%
Arthralgia
2%
Somnolence
2%
Insomnia
2%
Dysmenorrhoea
2%
Nasal congestion
2%
Abdominal discomfort
2%
Protein urine present
2%
White blood cell count decreased
2%
Hypertriglyceridaemia
2%
Neck pain
1%
Polyp
1%
Periostitis
1%
Candida infection
1%
Raynaud's phenomenon
1%
Mean cell volume increased
1%
Musculoskeletal chest pain
1%
Anogenital warts
1%
Skin fissures
1%
Blood creatine phosphokinase
1%
Tendon rupture
1%
Tendonitis
1%
Ingrown hair
1%
Photopsia
1%
Foot fracture
1%
Sunburn
1%
Presyncope
1%
Cervical dysplasia
1%
Scab
1%
Gastrointestinal pain
1%
Syncope
1%
Hepatitis C
1%
Radius fracture
1%
Overdose
1%
Polydipsia psychogenic
1%
Rash pruritic
1%
Gastrointestinal viral infection
1%
Blood bicarbonate decreased
1%
Urine ketone body present
1%
Burning sensation
1%
Glycosuria
1%
Motion sickness
1%
Bacteriuria
1%
Ear infection
1%
Oral herpes
1%
Lymphocyte count decreased
1%
Synovial cyst
1%
Hyperaesthesia
1%
Haematuria
1%
Hyperthyroidism
1%
Restlessness
1%
Multiple sclerosis
1%
Musculoskeletal discomfort
1%
Suicidal ideation
1%
Hordeolum
1%
Major depression
1%
Product administration error
1%
Blepharitis
1%
Contusion
1%
Foreign body in eye
1%
Suicidal behaviour
1%
Urinary sediment present
1%
Ophthalmic migraine
1%
Eye haemorrhage
1%
Fungal skin infection
1%
Transaminases increased
1%
Panic attack
1%
Lacrimation increased
1%
Photophobia
1%
Gastrooesophageal reflux disease
1%
Osteoporosis
1%
Hot flush
1%
Corneal abrasion
1%
Frequent bowel movements
1%
Drug reaction with eosinophilia and systemic
1%
Arthropod bite
1%
Lower limb fracture
1%
Pulmonary congestion
1%
Thermal burn
1%
Generalised tonic-clonic seizure
1%
Skin irritation
1%
Epilepsy
1%
Migraine
1%
Alcohol abuse
1%
Anxiety disorder
1%
Psychotic behaviour
1%
Hereditary optic atrophy
1%
Thyroiditis
1%
Ocular hyperaemia
1%
Constipation
1%
Eosinophilic oesophagitis
1%
Food poisoning
1%
Gastritis
1%
Salivary hypersecretion
1%
Tooth disorder
1%
Hepatosplenomegaly
1%
Hypersensitivity
1%
Bacterial abdominal infection
1%
Bronchitis viral
1%
Cellulitis
1%
Herpes zoster
1%
Infection
1%
Viral infection
1%
Head injury
1%
Monocyte count decreased
1%
Monocyte count increased
1%
Pruritus
1%
Psoriasis
1%
Orthostatic hypotension
1%
Rash maculo-papular
1%
Hypoacusis
1%
Eyelid pain
1%
Enterobiasis
1%
Eye infection
1%
Arthropod sting
1%
Wound
1%
Haemoglobin decreased
1%
Liver function test increased
1%
Red blood cell count decreased
1%
Periarthritis
1%
Conjunctivitis
1%
Infrequent bowel movements
1%
Skin lesion
1%
Delirium
1%
Heat stroke
1%
Sleep disorder
1%
Skin laceration
1%
Nephrolithiasis
1%
Tooth impacted
1%
Pancreatitis
1%
Multiple organ dysfunction syndrome
1%
Hypogammaglobulinaemia
1%
Appendicitis
1%
Diverticulitis intestinal perforated
1%
Pyelonephritis
1%
Trichomoniasis
1%
Ankle fracture
1%
Urobilinogen urine increased
1%
Ketoacidosis
1%
Metabolic acidosis
1%
Miscarriage of partner
1%
Hepatic failure
1%
Splenomegaly
1%
Tachycardia
1%
Chest pain
1%
Chills
1%
Cyst
1%
Medical device pain
1%
Pharyngitis
1%
Pharyngitis streptococcal
1%
Pulpitis dental
1%
Rhinitis
1%
Skin infection
1%
Tooth abscess
1%
Tooth infection
1%
Blood creatinine increased
1%
Blood glucose increased
1%
Blood phosphorus decreased
1%
Blood urea decreased
1%
Blood urea increased
1%
Blood uric acid increased
1%
Eosinophil count increased
1%
Gastric pH decreased
1%
Haematocrit decreased
1%
Weight increased
1%
Decreased appetite
1%
Hypercholesterolaemia
1%
Arthritis
1%
Intervertebral disc protrusion
1%
Seizure
1%
Tremor
1%
Adjustment disorder with depressed mood
1%
Anger
1%
Confusional state
1%
Depressive symptom
1%
Hallucination
1%
Hallucination, visual
1%
Irritability
1%
Mood altered
1%
Prostatitis
1%
Testicular pain
1%
Allergic bronchitis
1%
Asthma
1%
Dysphonia
1%
Dyspnoea
1%
Epistaxis
1%
Myocardial Infarction
1%
Disease Reoccurance
1%
Malpositioned teeth
1%
Cardiac Arrest
1%
Diverticulitis
1%
Anaemia
1%
Vulvovaginitis
1%
Acute kidney injury
1%
Coronary artery disease
1%
Excessive cerumen production
1%
Pupils unequal
1%
Vision blurred
1%
Visual acuity reduced
1%
Abdominal migraine
1%
Dental caries
1%
Dental necrosis
1%
White blood cells urine positive
1%
Dehydration
1%
Fluid retention
1%
Hyperlipidaemia
1%
Hyponatraemia
1%
Pain in extremity
1%
Pain in jaw
1%
Sinus headache
1%
Depressed mood
1%
Mood swings
1%
Respiratory acidosis
1%
Sinus congestion
1%
Tonsillar hypertrophy
1%
Upper respiratory tract congestion
1%
Upper-airway cough syndrome
1%
Orthosis user
1%
Pregnancy of partner
1%
Acne
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Raxone

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Idebenone
Group II: 2Placebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idebenone
FDA approved

Find a Location

Who is running the clinical trial?

Santhera PharmaceuticalsLead Sponsor
30 Previous Clinical Trials
2,651 Total Patients Enrolled
Prof Thomas Klopstock, MDPrincipal InvestigatorKlinikum der Universität München - Grosshadern, Neurologische Klinik und Poliklinik
Prof Patrick F Chinnery, MDPrincipal InvestigatorClinical Research Facility, 4th Floor Leazes Wing, Royal Victoria Infirmary
~5 spots leftby Nov 2025
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