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Antioxidant
Oral Idebenone for Fatty Liver Disease
Phase 1 & 2
Waitlist Available
Led By Natalie Torok, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of NASH: NAFLD activity score (NAS) of 4 or greater with a score of 1 for each of the following (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2)
Fibrosis (Ishak fibrosis score ≥1 on liver biopsy) within 6 months of enrollment with MELD<10, or based on MRE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 60: assessment of aes
Awards & highlights
Study Summary
This trial is testing a new drug to treat non-alcoholic steatohepatitis, a fatty liver disease. They will test how well the drug works and if it is safe.
Who is the study for?
Adults over 18 with non-alcoholic steatohepatitis (NASH) and moderate liver fibrosis can join this study. They must have a specific level of fat, inflammation, and cell damage in the liver but not severe liver dysfunction or other serious health issues like heart disease or recent drug trial participation.Check my eligibility
What is being tested?
The trial is testing Idebenone, an oral medication, against a placebo to see if it's safe and can improve liver health in NASH patients. Participants are randomly chosen to receive either the real drug or a fake pill without knowing which one they get.See study design
What are the potential side effects?
While the side effects for Idebenone in treating NASH aren't fully known yet, potential risks may include digestive discomfort, fatigue, skin reactions or headaches as commonly seen with new treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with NASH with a specific severity score.
Select...
My liver has some scarring but my overall liver function is still good.
Select...
I am an adult over 18 and not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 60: assessment of aes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 60: assessment of aes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary outcome measures
Change in fibrosis stage
Side effects data
From 2021 Phase 4 trial • 199 Patients • NCT0277400534%
Total
19%
Headache
17%
Nasopharyngitis
10%
Diarrhoea
8%
Nausea
8%
Alanine aminotransferase increased
7%
Blood creatine phosphokinase increased
7%
Abdominal pain upper
7%
Aspartate aminotransferase increased
7%
Oropharyngeal pain
6%
Cough
5%
Back pain
5%
Gamma-glutamyltransferase increased
4%
Toothache
4%
Influenza
4%
Fatigue
4%
Abdominal pain
4%
Sinusitis
4%
Depression
3%
Vomiting
3%
Dyspepsia
3%
Malaise
3%
Pyrexia
3%
Blood triglycerides increased
3%
Rash
3%
Visual impairment
3%
Upper respiratory tract infection
3%
Eye pain
2%
Hypertriglyceridaemia
2%
Gastroenteritis
2%
Neutrophil count increased
2%
Pain
2%
Influenza like illness
2%
Bronchitis
2%
Gastroenteritis viral
2%
Nasal congestion
2%
White blood cell count decreased
2%
Hypertension
2%
Ear pain
2%
Abdominal discomfort
2%
Seasonal allergy
2%
Urinary tract infection
2%
Lymphocyte count increased
2%
Neutrophil count decreased
2%
Protein urine present
2%
Neck pain
2%
Somnolence
2%
Anxiety
2%
Chromaturia
2%
Urine abnormality
2%
Dysmenorrhoea
2%
Lower respiratory tract infection
2%
Bacterial test positive
2%
Blood alkaline phosphatase increased
2%
Blood bilirubin increased
2%
Blood cholesterol increased
2%
Insomnia
2%
Myalgia
2%
Suicide attempt
2%
Arthralgia
2%
Dizziness
1%
Gastritis
1%
Eosinophilic oesophagitis
1%
Myocardial Infarction
1%
Pancreatitis
1%
Trichomoniasis
1%
Photopsia
1%
Suicidal ideation
1%
Vulvovaginitis
1%
Multiple organ dysfunction syndrome
1%
Hypogammaglobulinaemia
1%
Pupils unequal
1%
Malpositioned teeth
1%
Tooth disorder
1%
Coronary artery disease
1%
Lacrimation increased
1%
Photophobia
1%
Disease Reoccurance
1%
Diverticulitis intestinal perforated
1%
Chest pain
1%
Dental caries
1%
Cardiac Arrest
1%
Food poisoning
1%
Appendicitis
1%
Ankle fracture
1%
Dental necrosis
1%
Frequent bowel movements
1%
Infrequent bowel movements
1%
Gastrointestinal pain
1%
Diverticulitis
1%
Syncope
1%
Hereditary optic atrophy
1%
Pyelonephritis
1%
Ocular hyperaemia
1%
Tooth impacted
1%
Viral infection
1%
Salivary hypersecretion
1%
Thermal burn
1%
Excessive cerumen production
1%
Tachycardia
1%
Gastrooesophageal reflux disease
1%
Tooth infection
1%
Product administration error
1%
Weight increased
1%
Chills
1%
Haematocrit decreased
1%
Acne
1%
Cyst
1%
Urine ketone body present
1%
Bronchitis viral
1%
Bacterial abdominal infection
1%
Bacteriuria
1%
Polyp
1%
Tooth abscess
1%
Pharyngitis streptococcal
1%
Tonsillar hypertrophy
1%
Rhinitis
1%
Scab
1%
Synovial cyst
1%
Mood swings
1%
Ear infection
1%
Foot fracture
1%
Upper-airway cough syndrome
1%
Candida infection
1%
Hot flush
1%
Cellulitis
1%
Pulpitis dental
1%
Conjunctivitis
1%
Sunburn
1%
Tendon rupture
1%
Head injury
1%
Skin laceration
1%
Pain in jaw
1%
Ingrown hair
1%
Periarthritis
1%
Pharyngitis
1%
Skin infection
1%
Heat stroke
1%
Oral herpes
1%
Foreign body in eye
1%
Hallucination
1%
Rash pruritic
1%
Dehydration
1%
White blood cells urine positive
1%
Decreased appetite
1%
Periostitis
1%
Prostatitis
1%
Allergic bronchitis
1%
Contusion
1%
Radius fracture
1%
Blood urea decreased
1%
Corneal abrasion
1%
Blood creatinine increased
1%
Lower limb fracture
1%
Burning sensation
1%
Raynaud's phenomenon
1%
Overdose
1%
Blood uric acid increased
1%
Mood altered
1%
Gastric pH decreased
1%
Hypercholesterolaemia
1%
Testicular pain
1%
Epistaxis
1%
Upper respiratory tract congestion
1%
Intervertebral disc protrusion
1%
Osteoporosis
1%
Generalised tonic-clonic seizure
1%
Fluid retention
1%
Pain in extremity
1%
Anogenital warts
1%
Glycosuria
1%
Hyperlipidaemia
1%
Tendonitis
1%
Dysphonia
1%
Hyperaesthesia
1%
Respiratory acidosis
1%
Orthosis user
1%
Pregnancy of partner
1%
Dyspnoea
1%
Alopecia
1%
Sinus congestion
1%
Skin irritation
1%
Skin lesion
1%
Orthostatic hypotension
1%
Rash maculo-papular
1%
Miscarriage of partner
1%
Hepatic failure
1%
Hypoacusis
1%
Thyroiditis
1%
Vision blurred
1%
Visual acuity reduced
1%
Abdominal migraine
1%
Constipation
1%
Medical device pain
1%
Hypersensitivity
1%
Enterobiasis
1%
Eye infection
1%
Fungal skin infection
1%
Blood urea increased
1%
Mean cell volume increased
1%
Eosinophil count increased
1%
Haemoglobin decreased
1%
Liver function test increased
1%
Lymphocyte count decreased
1%
Monocyte count decreased
1%
Monocyte count increased
1%
Red blood cell count decreased
1%
Transaminases increased
1%
Urinary sediment present
1%
Musculoskeletal chest pain
1%
Musculoskeletal discomfort
1%
Migraine
1%
Ophthalmic migraine
1%
Presyncope
1%
Seizure
1%
Sinus headache
1%
Tremor
1%
Adjustment disorder with depressed mood
1%
Anger
1%
Confusional state
1%
Depressed mood
1%
Depressive symptom
1%
Panic attack
1%
Restlessness
1%
Sleep disorder
1%
Suicidal behaviour
1%
Cervical dysplasia
1%
Asthma
1%
Skin fissures
1%
Drug reaction with eosinophilia and systemic
1%
Anaemia
1%
Splenomegaly
1%
Motion sickness
1%
Hyperthyroidism
1%
Blepharitis
1%
Eye haemorrhage
1%
Eyelid pain
1%
Hepatosplenomegaly
1%
Gastrointestinal viral infection
1%
Hepatitis C
1%
Herpes zoster
1%
Hordeolum
1%
Infection
1%
Arthropod bite
1%
Arthropod sting
1%
Wound
1%
Blood bicarbonate decreased
1%
Blood creatine phosphokinase
1%
Blood glucose increased
1%
Blood phosphorus decreased
1%
Hallucination, visual
1%
Irritability
1%
Polydipsia psychogenic
1%
Haematuria
1%
Nephrolithiasis
1%
Pruritus
1%
Psoriasis
1%
Major depression
1%
Psychotic behaviour
1%
Acute kidney injury
1%
Urobilinogen urine increased
1%
Ketoacidosis
1%
Metabolic acidosis
1%
Epilepsy
1%
Multiple sclerosis
1%
Alcohol abuse
1%
Anxiety disorder
1%
Delirium
1%
Hyponatraemia
1%
Arthritis
1%
Pulmonary congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Raxone
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IdebenoneExperimental Treatment1 Intervention
Participants will take Idebenone 200 mg for 48 weeks, with study visits in clinic for physical and laboratory assessments at weeks 0, 2, 4, 12, 24, 36, and 48 weeks during treatment period and at 4, and 12 weeks after the last dose.
Group II: PlaceboPlacebo Group1 Intervention
Participants will take Placebo for 48 weeks, with study visits in clinic for physical and laboratory assessments at weeks 0, 2, 4, 12, 24, 36, and 48 weeks during treatment period and at 4, and 12 weeks after the last dose.
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?
Stanford UniversityLead Sponsor
2,396 Previous Clinical Trials
17,341,510 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
110 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,364 Previous Clinical Trials
4,315,357 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
9,985 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Natalie Torok, MD1.02 ReviewsPrincipal Investigator - Stanford University
Stanford University
2 Previous Clinical Trials
139 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
139 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been recruited for this research endeavor?
"Unfortunately, this research project is no longer accepting patients. It was initially posted on July 30th 2021 and its information was last amended on October 24th 2022. If you are still looking for other studies related to NASH, there are currently 234 clinical trials in need of volunteers while 5 separate experiments require participants with Idebenone treatment."
Answered by AI
Are participants being enrolled in this investigation currently?
"Unfortunately, this medical trial is no longer accepting patients. The first posting was on July 30th 2021 and the last update occurred October 24 2022. There are currently 234 clinical trials recruiting for non-alcoholic steatohepatitis (NASH) and 5 trials actively enrolling participants to study Idebenone's effects."
Answered by AI
Have there been other investigations utilizing Idebenone?
"Currently, there are 5 active trials for Idebenone with two of them at stage 3. Hangzhou, Zhejiang is the primary site hosting these studies but they are also offered in another five locations."
Answered by AI
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