Uses of Idebenone + Side Effects

Study of the drug ‘idebenone’ for Duchenne muscular dystrophy

Uses of Idebenone + Side Effects

Expected end Date

01/12/2013

Location

Austria, Belgium, France, Germany, The Netherlands, Sweden, Switzerland and the USA. For stage 2 of the trial (see below) an additional ~ 15 study centers in Europe and North America will be opened at a later time

This trial is a Phase 3 trial investigating the effect of administering a drug called idebenone to people with Duchenne muscular dystrophy. Idebenone works by increasing the production of energy by the mitochondria- the energy factories of cells.

It is also thought to be able to protect cells from damage due to its anti-oxidative properties.

Idebenone is currently being investigated for its potential to treat a variety of neuromuscular conditions and mitochondrial diseases including Friedreich’s ataxia, for which the drug is approved in Canada (tradename “Catena®”).

This trial follows on from a Phase 2 trial in which idebenone showed promise as a treatment for Duchenne muscular dystrophy. In the Phase 2 trial (called the DELPHI trial), 13 patients received idebenone at a daily dose of 450 mg for 52 weeks.

Compared with eight patients on placebo, the patients on idebenone showed significantly improved heart muscle function. Furthermore, patients receiving idebenone improved on some measures of breathing strength.

Idebenone was also found to not cause any more side-effects than placebo.

This Phase 3 trial (called the DELOS trial) will primarily investigate whether treatment with idebenone (at daily dose of 900 mg) compared to placebo improves breathing strength and lung function in patients with Duchenne.

It will also look at the effect of idebenone on muscle strength, muscle function and quality of life, and test the safety of treatment with idebenone. Patients will receive idebenone or placebo for a period of 12 months.

Who can be involved in the trial?

This study aims to recruit about 240 individuals aged between 10 and 18 years with a diagnosis of Duchenne muscular dystrophy. This diagnosis must have been confirmed by genetic testing or by substantially reduced levels of dystrophin protein. Boys who are able to walk independently as well as wheelchair users can participate in this trial.

The trial will be conducted in two stages.

In the first stage, patients will be enrolled if they have never used glucocorticoids (steroids) or if they have stopped using glucocorticoids at least 12 months prior to the study.

A total of 40 patients from this group will be enrolled at eight study centres in Europe and the USA. The enrolment of patients using glucocorticoids is foreseen later in a second stage of the study.

Participants in the study must not be dependent on assisted ventilation at the beginning of the study and must be able to comply with the study procedures. For more details of who can participate in the trial, see ‘Further trial details’ below.

What happens during the trial?

Participants will be randomly assigned to one of two groups. The first group will take idebenone at 900 mg/day (given as 300 mg three times a day with meals) for a year. The second group will take a placebo. Participating patients are requested to come to the hospital up to eight times within 1 year for assessments of the effectiveness and safety of taking idebenone.

Where is the study taking place?

Stage 1 of the DELOS trial is being carried out in eight study centres in Europe and the USA:• Austria (Vienna)• Belgium (Leuven)• France (Paris)• Germany (Essen)• The Netherlands (Leiden)• Sweden (Stockholm)• Switzerland (Lausanne)

• USA (Philadelphia)

For stage 2 of the trial (patients using glucocorticoids) an additional ~ 15 study centers in Europe and North America will be opened at a later time.

Travel costs will be reimbursed.

In most circumstances, for somebody to participate in a clinical trial, they need to live near the team of people who are conducting the research, because they need to be closely monitored.

How could the results of the trial benefit patients?

If the results from this trial confirm that treatment with idebenone benefits people with Duchenne muscular dystrophy, this study could form the basis for an application for regulatory approval of the use of idebenone as a treatment for people with the condition.

Official name of the Trial:

Phase 3 Study of Idebenone in Duchenne Muscular Dystrophy (DELOS)

Further trial details:

For further information on the trial and detailed inclusion and exclusion please click on the link below. Sometimes these details can be quite technical. If you have any questions please discuss this with your clinician or contact the clinical trial organisers.

http://clinicaltrials.gov/show/NCT01027884

This trial is a Phase 3 trial investigating the effect of administering a drug called idebenone to people with Duchenne muscular dystrophy. Idebenone works by increasing the production of energy by the mitochondria- the energy factories of cells.

It is also thought to be able to protect cells from damage due to its anti-oxidative properties.

Idebenone is currently being investigated for its potential to treat a variety of neuromuscular conditions and mitochondrial diseases including Friedreich’s ataxia, for which the drug is approved in Canada (tradename “Catena®”).

This trial follows on from a Phase 2 trial in which idebenone showed promise as a treatment for Duchenne muscular dystrophy. In the Phase 2 trial (called the DELPHI trial), 13 patients received idebenone at a daily dose of 450 mg for 52 weeks.

Compared with eight patients on placebo, the patients on idebenone showed significantly improved heart muscle function. Furthermore, patients receiving idebenone improved on some measures of breathing strength.

Idebenone was also found to not cause any more side-effects than placebo.

This Phase 3 trial (called the DELOS trial) will primarily investigate whether treatment with idebenone (at daily dose of 900 mg) compared to placebo improves breathing strength and lung function in patients with Duchenne.

It will also look at the effect of idebenone on muscle strength, muscle function and quality of life, and test the safety of treatment with idebenone. Patients will receive idebenone or placebo for a period of 12 months.

Source: https://www.musculardystrophyuk.org/clinical-trials/study-of-the-drug-idebenone-for-duchenne-muscular-dystrophy/

Raxone: Uses, Side Effects, Benefits/Risks | Drugs.com

Uses of Idebenone + Side Effects

Active Substance: idebenone
Common Name: idebenone
ATC Code: N07
Marketing Authorisation Holder: Santhera Pharmaceuticals (Deutschland) GmbH
Active Substance: idebenone
Status: Authorised
Authorisation Date: 2015-09-08
Therapeutic Area: Optic Atrophy, Hereditary, Leber
Pharmacotherapeutic Group: Other nervous system drugs

Therapeutic Indication

Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON).

What is Raxone and what is it used for?

Raxone is a medicine used to treat visual impairment in adults and adolescents aged 12 years and over with Leber’s hereditary optic neuropathy (LHON), an inherited disease characterised by progressive loss of sight. Raxone contains the active substance idebenone.

Because the number of patients with Leber's hereditary optic neuropathy is low, the disease is considered ‘rare’, and Raxone was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 February 2007.

Raxone is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Raxone contains idebenone at a different strength. The reference medicine for Raxone is Mnesis (45 mg tablets).

How is Raxone used?

Raxone can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in LHON. Raxone is available as 150 mg tablets, and the recommended dose is two tablets taken three times a day with food.

How does Raxone work?

The active substance in Raxone, idebenone, is an anti-oxidant agent that acts on mitochondria (the structures inside cells that produce the energy necessary for cells to function). Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.

This means that mitochondria do not work properly to generate energy, and produce toxic forms of oxygen (free radicals) that damage nerve cells in the eye that are needed for vision.

Idebenone is thought to help improve production of energy by restoring mitochondrial function, thereby preventing the cellular damage and the loss of sight seen in LHON.

What benefits of Raxone have been shown in studies?

Raxone has been investigated in one main study involving 85 patients with LHON, in which it was compared with placebo (a dummy treatment) over 24 weeks.

The main measure of effectiveness was improvement in vision, mostly the numbers of letters patients were able to read on a standard eye test chart. By the end of the study, patients treated with Raxone were able to read on average 3 to 6 letters more compared with patients receiving placebo.

Furthermore, some patients who were classified as ‘off chart’ (unable to read any letters on the chart) at the beginning of the study were able to read at least one line during the eye test after treatment, and this was also considered clinically important.

Additionally, 30% of patients treated with Raxone (16 53) had a clinically relevant recovery of vision in at least one eye, compared with 10% of patients (3 29) in the placebo group.

Additional supportive data on the benefits of Raxone came from an expanded access program through which Raxone was made available to individual patients not participating in a clinical study, and from a case record survey, which included data from patients with LHON who did not receive any treatment.

Analyses of all these data showed a consistent pattern whereby generally a larger proportion of patients treated with Raxone had vision improvement compared with untreated or placebo-treated patients.

What are the risks associated with Raxone?

The most common side effects with Raxone (which may affect more than 1 in 10 people) are nasopharyngitis and cough; mild to moderate diarrhoea and back pain are also common (affecting up to 1 in 10 people).

For the full list of all side effects and restrictions with Raxone, see the package leaflet.

Why is Raxone approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Raxone are greater than its risks and recommended that it be approved for use in the EU.

The Committee noted the lack of treatments for preventing or reversing the vision loss in patients with LHON.

The results of the main study showed an improvement in vision in patients treated with Raxone, and this trend towards a beneficial effect was confirmed by additional data from an expanded access program and a case record survey.

With regard to the safety of Raxone, the majority of side effects seen with the medicine were mild or moderate in intensity.

Raxone has been authorised under ‘exceptional circumstances’. This is because it has not been possible to obtain complete information about Raxone due to the rarity of the disease. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Raxone?

Since Raxone has been approved under exceptional circumstances, the company that markets Raxone will conduct additional studies on the long-term effects and safety of Raxone, and will establish and maintain a registry of LHON patients treated with Raxone.

What measures are being taken to ensure the safe and effective use of Raxone?

A risk management plan has been developed to ensure that Raxone is used as safely as possible. this plan, safety information has been included in the summary of product characteristics and the package leaflet for Raxone, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Raxone

The European Commission granted a marketing authorisation valid throughout the European Union for Raxone on 8 September 2015.

For more information about treatment with Raxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Source: https://www.drugs.com/uk/raxone.html

Introducing Idebenone

Uses of Idebenone + Side Effects

Antioxidants are, rightly, having a big moment within the beauty industry. This is because they help prevent or delay damage to skin cells from free radicals such as pollution and sun damage, and we are only just waking up to the reality of the effects of these aggressors on the skin.

Supercharged antioxidant Idebenone, an ingredient in certain Prevage® formulas for which Elizabeth Arden holds the patent in the cosmetic industry, forms the basis of Elizabeth Arden’s entire luxurious Prevage range.

Prevage is Elizabeth Arden’s most premium and high-tech anti-ageing line. So what makes Idebenone so revered and what can it do to help protect your skin? Discover its origin, beauty benefits and where you can find it.

What is Idebenone?

Idebenone is a fine orange antioxidant powder that was originally used medically during organ transplants as it prevents their oxidation.

Idebenone is a very powerful antioxidant that’s found throughout the Prevage lineDr Dendy Engelman, dermatologist, cosmetic and skin cancer surgeon

In 2005, pharmaceutical company Allergen discovered that it also had antioxidant benefits when used topically on the skin and was eager to secure a partner to integrate this ingredient in the cosmetic industry for use in the anti-ageing space. It was here that its relationship with Elizabeth Arden began.

Elizabeth Arden now owns the patent to include Idebenone within its Prevage formulations cosmetically.

“Idebenone is a very powerful antioxidant that’s found throughout the Prevage line,” explains Dr Dendy Engelman, a dermatologist, cosmetic and skin cancer surgeon in New York City.

“It was first used medically but was later found, through topical use, to protect skin cells from environmental damage. This is due to its potent antioxidant behaviour that can improve skin’s appearance – from diminishing the appearance of fine lines and wrinkles, to reducing dryness, and improving skin texture.”

What makes it so good?

“In critical studies, Idebenone was discovered to be much more potent than other antioxidants such as vitamin E,” says Dr Engelman. “The benefits of using Idebenone in particular are that it’s more phyto-protective, so it protects against damage from smoke and different toxic avengers that we encounter on a daily basis.

“The skin appears much healthier-looking and smoother with less hyperpigmentation, photo damage, wrinkles, and fine lines.”

The science behind the magic of Prevage

Elizabeth Arden’s scientific research regarding the effects of Idebenone on the skin is tested under the rigorous EPF® (Environmental Protection Factor™) protocol.

This assesses how much protection it provides against environmental pollutants (such as pollution and smoke), which can accelerate the signs of ageing.

When the protective properties of Idebenone were compared to five leading antioxidants* against environmental damage, Elizabeth Arden found that Idebenone was proven as a super powerful antioxidant with an EPF rating of 95 100.

Your Prevage regime

Idebenone is present within every Prevage product: from daily cleansers, serums, night creams to foundations and more targeted products the peel-off mask.

To help protect the skin from damage triggered by environmental aggressors and the natural process of skin ageing, Dr Engelman advises beginning your routine with the Prevage Anti-aging Treatment Boosting Cleanser – a light and creamy foaming facial wash that removes impurities and prepares the skin for the rest of the regime.

Across the range: Idebenone is present within every Prevage product

Follow up with one of the brand’s best-selling serums such as Prevage Anti-Ageing + Intensive Repair Daily Serum for a firmer-looking, even-toned and radiant complexion, before adding extra hydration with the Prevage Anti-Ageing moisture cream SPF 30.

“Prevage City Smart Broad Spectrum Hydrating Shield SPF 50 should be the last product you apply before make-up as it contains UV protection and a pollution shield,” says Dr Engelman.

Recognised by experts

The effects of Idebenone on the skin are well known by the beauty industry. In fact, it’s earned Prevage 220 awards** in total, including the prestigious Marie Claire Prix D'Excellence.

Protect your skin

Did you know that the environment is visibly ageing your skin?

Elizabeth Arden has teamed up with Telegraph Spark to reveal the benefits of its latest skincare saviour, Prevage® Progressive Renewal Treatment. Could this progressive overnight peeling treatment transform our beauty regimes for ever?

For more information, visit elizabetharden.co.uk or your nearest Elizabeth Arden counter for your personalised consultation.

Always read the label and test on a small area of skin before use.

*When compared to antioxidants in face products, Idebenone in Prevage® surpasses alpha lipoic acid, kinetin, vitamin C, vitamin E, and ubiquinone in environmental protection against oxidative stress due to sun, smoke and pollution. EPF® and Environmental Protection Factor™ are certification marks and trademarks owned by Pharma Cosmetix Research, L.L.C.

**Awards granted to Elizabeth Arden Prevage products by international press since 2006.

Source: https://www.telegraph.co.uk/beauty/skincare-tips/idebenone-wonder-ingredient/

Idebenone: Health Benefits, Uses, Side Effects, Dosage & Interactions

Uses of Idebenone + Side Effects

Anonymous. Idebenone – monograph. Altern Med Rev 2001;6:83-6.

Artuch R, Colome C, Vilaseca MA, et al. Monitoring of idebenone treatment in patients with Friedreich's ataxia by high-pressure liquid chromatography with electrochemical detection. J Neurosci Methods 2002;115:63-6. View abstract.

Buyse G, Mertens L, Di Salvo G, et al. Idebenone treatment in Friedreich's ataxia: neurological, cardiac, and biochemical monitoring. Neurology 2003;60:1679-81. . View abstract.

Di Prospero NA, Sumner CJ, Penzak SR, et al. Safety, tolerability, and pharmacokinetics of high-dose idebenone in patients with Friedreich ataxia. Arch Neurol 2007;64:803-8. View abstract.

Esposti MD, Ngo A, Ghelli A, et al. The interaction of Q analogs, particularly hydroxydecyl benzoquinone (idebenone), with the respiratory complexes of heart mitochondria. Arch Biochem Biophys 1996;330:395-400. View abstract.

Filla A, Moss AJ. Idebenone for treatment of Friedreich's ataxia? Neurology 2003;60:1569-70.

Geromel V, Darin N, Chretien D, et al. Coenzyme Q(10) and idebenone in the therapy of respiratory chain diseases: rationale and comparative benefits. Mol Genet Metab 2002;77:21-30. View abstract.

Gutzmann H, Hadler D. Sustained efficacy and safety of idebenone in the treatment of Alzheimer's disease: update on a 2-year double-blind multicentre study. J Neural Transm 1998;54:301-10. View abstract.

Hausse AO, Aggoun Y, Bonnet D, et al. Idebenone and reduced cardiac hypertrophy in Friedreich's ataxia. Heart 2002;87:346-9. View abstract.

Ihara Y, Namba R, Kuroda S, et al. Mitochondrial encephalomyopathy (MELAS): pathological study and successful therapy with coenzyme Q10 and idebenone. J Neurol Sci 1989;90:263-71. View abstract.

Ikejiri Y, Mori E, Ishii K, et al. Idebenone improves cerebral mitochondrial oxidative metabolism in a patient with MELAS. Neurology 1996;47:583-5. View abstract.

Lerman-Sagie T, Rustin P, Lev D, et al. Dramatic improvement in mitochondrial cardiomyopathy following treatment with idebenone. J Inherit Metab Dis 2001;24:28-34. View abstract.

Mariotti C, Solari A, Torta D, et al. Idebenone treatment in Friedreich patients: one-year-long randomized placebo-controlled trial. Neurology 2003;60:1676-9. View abstract.

Mashima Y, Hiida Y, Oguchi Y. Remission of Leber's hereditary optic neuropathy with idebenone. Lancet 1992;340:368-9. View abstract.

Pisano P, Durand A, Autret E, et al. Plasma concentrations and pharmacokinetics of idebenone and its metabolites following single and repeated doses in young patients with mitochondrial encephalomyopathy. Eur J Clin Pharmacol 1996;51:167-9. View abstract.

Rego AC, Santos MS, Oliveira CR. Influence of the antioxidants vitamin E and idebenone on retinal cell injury mediated by chemical ischemia, hypoglycemia, or oxidative stress. Free Radic Biol Med 1999;26:1405-17. View abstract.

Rustin P, von Kleist-Retzow JC, Chantrel-Groussard K, et al. Effect of idebenone on cardiomyopathy in Friedreich's ataxia: a preliminary study. Lancet 1999;354:477-9. View abstract.

Schols L, Vorgerd M, Schillings M, et al. Idebenone in patients with Friedreich ataxia. Neurosci Lett 2001;306:169-72. View abstract.

Shivaram KN, Winklhofer-Roob BM, Straka MS, et al. The effect of idebenone, a coenzyme Q analogue, on hydrophobic bile acid toxicity to isolated rat hepatocytes and hepatic mitochondria. Free Radic Biol Med 1998;25:480-92. View abstract.

Weyer G, Babej-Dolle RM, Hadler D, et al. A controlled study of 2 doses of idebenone in the treatment of Alzheimer's disease. Neuropsychobiology 1997;36:73-82. . View abstract.

Source: https://www.rxlist.com/idebenone/supplements.htm

Idebenone

Uses of Idebenone + Side Effects

There are many skin care ingredients that are synonymous with aging skin, but most people who are in the market for anti aging skin care products have ly heard of idebenone.

This chemical was originally produced to treat a number of medical ailments related to aging and has since been used by many skin care companies due to its antioxidant properties.

While some studies are still ongoing, more companies are releasing anti aging skin care products with idebenone, even though its origins were far outside the skin care field.

The Genesis of Idebenone

Idebenone was originally created by a Japanese pharmaceutical company to treat the effects of Alzheimer’s disease, particularly the deterioration of memory. The chemical make-up of idebenone is almost identical to the antioxidant coenzyme Q10.

While its effects on Alzheimer’s patients were limited, some pharmaceutical companies continue to test the chemical’s effectiveness on other cognitive and neurological diseases.

More recently, skin care companies have turned their attention to idebenone and its power as an antioxidant and a free radical fighter as it is believed to be safer than other man-made skin care ingredients.

Idebenone’s Proposed Effects on Aging Skin

Idebenone is being used in a number of anti aging skin care products for a variety of purposes, but its biggest believed benefits come from the powerful antioxidant properties.

For example, wrinkles, fine lines, and even age spots all form in the process of natural aging, but these issues also have a great deal to do with exposure to the sun.

UV rays contain free radicals that destroy skin cells from the inside out and damage both elastin and collagen, which causes skin to sag and wrinkle. It is believed that creams containing idebenone may be prevent wrinkles by fighting free radicals and protecting skin cells.

The healthier the skin is, the more collagen it produces, which helps it look firmer. Idebenone may also be helpful in reducing inflammatory responses in the skin, as well as redness and swelling.

Possible Side Effects

While few problems have arisen from the use of idebenone-based skin creams, some individuals have experienced redness, irritation, and stinging. If you’re considering the use of this product, the best way to avoid any possible irritation is to understand your own skin type.

If you have skin that is sensitive to many beauty products, you may want to test a small patch of skin first, before applying it elsewhere on your body.

All products that contain idebenone are sold over the counter.

However, if you have experienced outbreaks with anti aging creams in the past, you should see your doctor or skin care specialist to discuss any possible problems that may arise with the use of idebenone creams.

Using Idebenone Cream Effectively

There are a number of creams on the market today that are using this chemical as their main ingredient. However, since most of these creams are more expensive than other over-the-counter brands, you should learn to use them to their full potential.

Before you apply any kind of idebenone anti aging cream to your face, open your pores with a facial steamer for ten to fifteen minutes. Once the steaming is complete, pat your face dry with a clean, soft cloth. Never rub your face with a towel in order to dry it, as this might irritate the skin.

Once your skin is completely dry, apply the cream directly to problem areas and work outward, using your fingertips. The steaming will allow the cream to penetrate deeper for better results. Be sure to store idebenone creams away from sunlight, as UV rays may weaken its antioxidants over time.

Source: https://thedermreview.com/idebenone/

Ubiquinone Uses, Benefits & Side Effects – Drugs.com Herbal Database

Uses of Idebenone + Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 17, 2019.

What are other common names?

  • Coenzyme Q-10
  • Adelir
  • Coenzyme Q10
  • Coenzyme Q10
  • CoQ10
  • Heartcin
  • Inokiton
  • Mitoquinone
  • Neuquinone
  • Taidecanone
  • Ubidecarenone
  • Ubiquinol
  • Ubiquinone-10
  • Udekinon

Ubiquinone is also known as Coenzyme Q10 or CoQ10. It is used by some people to improve heart function and treat heart failure. Others may use it to help lower high blood pressure. Some people believe CoQ10 will help with nerve problems in diseases diabetes or migraines. Others may take it to help with muscle or nerve problems caused by not enough CoQ10.

  • Always check with your doctor before you use a natural product. Some products may not mix well with drugs or other natural products.

  • This product may interfere with some lab tests. Be sure to talk with your doctor about this and all drugs you are taking.

  • Take extra care if you are taking drugs to thin your blood. These are drugs warfarin (Coumadin).

  • Take extra care and check with your doctor if you have:

    • Heart problems

    • High blood pressure

    • Diabetes

  • Upset stomach

  • Stomach cramps

  • Loss of appetite

  • Tiredness

  • Change in color of urine

  • Signs of a very bad reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat. Go to the ER right away.

  • Very bad throwing up

  • Very bad belly pain

  • Very bad loose stools

  • Very bad headache

  • Blood in your stool or stools are dark and tar colored

  • Throwing up blood

2016-11-28

This information is not specific medical advice and does not replace information you receive from your healthcare provider. Only your healthcare provider has the knowledge and training to provide advice that is right for you.

You should not rely on this information in deciding whether or not to use, or accept your healthcare provider’s advice regarding use of, any natural products or similar treatments, therapies, or life-style choices.

This information does not endorse any natural products or similar treatments, therapies, or life-style choices as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information.

It does NOT include all information about natural products, possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to you. You must talk with your healthcare provider for complete information about your health and treatment options.

Copyright © 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Source: https://www.drugs.com/npc/ubiquinone.html

healthyincandyland.com