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mTOR inhibitor
Long-Term Safety of Everolimus for Tuberous Sclerosis
Phase 3
Waitlist Available
Research Sponsored by Novartis 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 day 1 up to approximately 10 years, assessed every 12 weeks,
Awards & highlights
Study Summary
This trial is for patients with TSC and refractory seizures who are currently receiving everolimus treatment and are determined to be benefiting from it, in order to evaluate the long-term safety of the treatment.
Who is the study for?
This trial is for patients with Tuberous Sclerosis Complex (TSC) and hard-to-treat seizures who are already part of the EXIST-3 study, taking everolimus, and seeing benefits. They must have followed the previous study's rules well and agree to keep doing so. People can't join if they've stopped everolimus in EXIST-3 or if it's now approved and paid for in their country.Check my eligibility
What is being tested?
The trial is looking at the long-term safety of a drug called everolimus in patients with TSC who experience seizures that don’t respond well to other treatments. These patients have seen improvements from this drug during a prior study (EXIST-3) and will continue treatment under observation.See study design
What are the potential side effects?
Everolimus may cause mouth ulcers, skin problems, infections due to a weakened immune system, high blood sugar levels, kidney issues, lung or breathing problems, delayed wound healing among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 up to approximately 10 years, assessed every 12 weeks,
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to approximately 10 years, assessed every 12 weeks,
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurances of adverse events and serious adverse events
Secondary outcome measures
Percentage of patients with clinical benefit
Side effects data
From 2019 Phase 3 trial • 235 Patients • NCT0317623863%
Stomatitis
27%
Decreased appetite
26%
Hyperglycaemia
25%
Aspartate aminotransferase increased
24%
Rash
23%
Alanine aminotransferase increased
22%
Cough
19%
Anaemia
16%
Weight decreased
16%
Fatigue
16%
Blood cholesterol increased
15%
Gamma-glutamyltransferase increased
15%
Diarrhoea
13%
Pneumonitis
12%
Upper respiratory tract infection
12%
Headache
12%
Nausea
12%
Hypertriglyceridaemia
11%
Back pain
11%
Pruritus
9%
Myalgia
9%
Insomnia
9%
Blood lactate dehydrogenase increased
8%
Arthralgia
8%
Dyspnoea
8%
Productive cough
8%
Dyspepsia
8%
Oedema peripheral
7%
Dysgeusia
7%
Pain in extremity
6%
Constipation
6%
Pyrexia
6%
Hypertension
5%
Neutrophil count decreased
5%
Dyslipidaemia
5%
Asthenia
5%
Hypercholesterolaemia
5%
Aphthous ulcer
5%
Pneumonia
5%
Urinary tract infection
5%
Lymphoedema
5%
Epistaxis
5%
Thrombocytopenia
5%
Blood alkaline phosphatase increased
5%
Dry skin
4%
Abdominal pain
4%
Hypokalaemia
4%
Hypophosphataemia
4%
Mouth ulceration
4%
Toothache
4%
Peripheral swelling
4%
Rhinorrhoea
4%
Acne
4%
Urticaria
4%
Blood creatinine increased
3%
Cellulitis
3%
White blood cell count decreased
3%
Face oedema
3%
Vomiting
3%
Nail disorder
3%
Abdominal discomfort
3%
Abdominal pain upper
3%
Diabetes mellitus
3%
Depression
3%
Non-cardiac chest pain
3%
Influenza
3%
Nasopharyngitis
3%
Pharyngitis
3%
Haemoglobin decreased
3%
Oropharyngeal pain
3%
Hyperkalaemia
3%
Hyperlipidaemia
3%
Paraesthesia
3%
Alopecia
3%
Dermatitis acneiform
2%
Influenza like illness
2%
Mucosal inflammation
2%
Flank pain
2%
Neck pain
2%
Musculoskeletal pain
2%
Platelet count decreased
2%
Hypoaesthesia
2%
Eczema
2%
Onychomadesis
2%
Dizziness
2%
Rash maculo-papular
2%
Haemorrhoids
2%
Pain
2%
Vitamin D deficiency
2%
Pleural effusion
2%
Blood triglycerides increased
1%
Gastric ulcer
1%
Abdominal distension
1%
Ascites
1%
Cardiopulmonary failure
1%
Gait inability
1%
Haematochezia
1%
Bone pain
1%
Interstitial lung disease
1%
Urethritis
1%
Ingrowing nail
1%
Eye pain
1%
Tachycardia
1%
Vision blurred
1%
Atypical pneumonia
1%
Herpes virus infection
1%
Gastroenteritis
1%
Muscular weakness
1%
Urosepsis
1%
Cartilage injury
1%
Ligament sprain
1%
Liver function test increased
1%
Eastern cooperative oncology group performance status worsened
1%
Joint stiffness
1%
Femur fracture
1%
Spinal pain
1%
Onycholysis
1%
Contrast media allergy
1%
Asthma
1%
Dehydration
1%
Viral infection
1%
Soft tissue infection
1%
Cardiac failure
1%
Large intestinal haemorrhage
1%
Hyponatraemia
1%
Dental caries
1%
Hypomagnesaemia
1%
Pain in jaw
1%
Cardiac arrest
1%
Left ventricular failure
1%
Ventricular tachycardia
1%
Abdominal hernia
1%
Diabetes mellitus inadequate control
1%
Joint effusion
1%
Metastases to lung
1%
Folliculitis
1%
Furuncle
1%
Gingivitis
1%
Lower respiratory tract infection
1%
Oral herpes
1%
Sinusitis
1%
Hypocalcaemia
1%
Breast pain
1%
Dyspnoea exertional
1%
Haemoptysis
1%
Wheezing
1%
Palmar-plantar erythrodysaesthesia syndrome
1%
Hot flush
1%
Atrial fibrillation
1%
Dysphagia
1%
Gastric haemorrhage
1%
Tumour necrosis
1%
Gastrooesophageal reflux disease
1%
Oral pain
1%
Musculoskeletal chest pain
1%
Rash papular
1%
Rash pruritic
1%
Respiratory failure
1%
Skin ulcer
1%
Pulmonary embolism
1%
Pulmonary oedema
1%
Overdose
1%
Leukopenia
1%
Neutropenia
1%
Tumour pain
1%
Central nervous system haemorrhage
1%
Hydrocephalus
1%
Intracranial aneurysm
1%
Lethargy
1%
Acute kidney injury
1%
Renal failure
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Asian
Non-Asian
Trial Design
1Treatment groups
Experimental Treatment
Group I: everolimusExperimental Treatment1 Intervention
everolimus, 2mg dispersible tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
everolimus
2005
Completed Phase 3
~1550
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,147 Total Patients Enrolled
8 Trials studying Tuberous Sclerosis
769 Patients Enrolled for Tuberous Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are already taking everolimus as part of another study sponsored by Novartis, called EXIST-3, and have completed all the necessary steps for that study.I am taking everolimus with other treatments for seizures, but AEDs are okay.Everolimus is approved and covered for my TSC-related seizures in my country.My current treatment with everolimus is working for me.
Research Study Groups:
This trial has the following groups:- Group 1: everolimus
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are young adults within the target age range for this experiment?
"The eligibility requirements for this trial include being over 2 years old and under 65."
Answered by AI
What was the outcome of everolimus's FDA evaluation?
"Everolimus has received a safety rating of 3. This is because it is a Phase 3 trial, which means that there is both some efficacy data as well as multiple rounds of supportive safety data."
Answered by AI
What are the main conditions that everolimus is used to treat?
"Everolimus is most commonly used to treat kidney transplant rejection, but it can also be prescribed for conditions like Waldenstrom macroglobulinemia, lung cancer, and advanced carcinoid tumors."
Answered by AI
What is the clinical evidence to support everolimus use?
"everolimus was first researched in 2008 at the Sheba Medical Center. Out of the 98 ongoing clinical trials, 405 have been completed with a large portion taking place in Oakland, California."
Answered by AI
Are there many different research institutions conducting this clinical trial in Canada?
"There are 15 sites enrolling patients in this trial, with some notable locations including UCSF Benioff Children s Hospital in Oakland, University of Chicago Medical Center in Chicago, and TGen/APNNA SC in Phoenix."
Answered by AI
Can patients sign up for this experiment right now?
"According to the clinicaltrials.gov website, this clinical trial is not currently looking for new participants. The study was posted on April 2nd, 2017 and had its last edit on September 29th, 2022. There are 694 other studies that are actively recruiting patients."
Answered by AI
How many people are being allowed to participate in this research?
"Unfortunately, this clinical trial is not currently seeking patients. The listing was created on April 2nd, 2017 and last edited September 29th, 2022. However, there are 596 other active trials for sclerosis and 98 for everolimus that may be of interest."
Answered by AI
Which type of patients are eligible for participation in this research?
"Eligible patients for this clinical study must have sclerosis and be between 2 to 65 years old. The target number of participants is 206 individuals."
Answered by AI
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