Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment
Study Purpose
The purpose of this study is to evaluate the long-term safety in patients with TSC and
refractory seizures who are currently receiving everolimus treatment in the
Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued
treatment as judged by the investigator at the completion of EXIST-3
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
2 Years - 65 Years
Gender
All
More Inclusion & Exclusion Criteria
Key
Inclusion Criteria:
- Patient is currently enrolled in the Novartis-sponsored EXIST-3 study, receiving
everolimus, and has fulfilled all its requirements.
- Patient is currently benefiting from treatment with everolimus, as determined by the
Investigator.
- Patient has demonstrated compliance, as assessed by the Investigator,with the parent
study protocol requirements.
- Patient is willing and able to comply with scheduled visits and treatment plans.
- Written informed consent/adolescent assent obtained prior to enrolling into the
roll-over study.
Key
Exclusion Criteria:
- Patient has been permanently discontinued from everolimus study treatment in EXIST-3
study.
- Everolimus is approved for patients with TSC and refractory seizures and is
reimbursed in the local country.
- Patients who are receiving everolimus in combination with unapproved or experimental
treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the
purpose of seizure control.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 3
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Novartis Pharmaceuticals
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Active, not recruiting
Countries
Australia, Belgium, Canada, Colombia, France, Hungary, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Tuberous Sclerosis Complex
Additional Details
This is a multi-center, open label study to evaluate the long term safety of everolimus
in patients with TSC and refractory seizures currently being treated in the
Novartis-sponsored study EXIST-3 study and are judged by their parent study investigator
as benefiting from the current study treatment. The study is expected to remain open for
approximately 10 years (or until 31-Dec-2022 in the UK) from First Patient First Visit
(FPFV).
Patients will continue to be treated in this study until they are no longer benefiting
from their everolimus treatment as judged by the Investigator or until one of the
protocol defined discontinuation criteria is met or everolimus becomes commercially
available according to local regulations.
Arms & Interventions
Arms
Experimental: everolimus
everolimus, 2mg dispersible tablets
Interventions
Drug: - everolimus
everolimus, 2mg dispersible tablets
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
TGen APNNA, Phoenix 5308655, Arizona 5551752
Status
Address
TGen APNNA
Phoenix 5308655, Arizona 5551752, 85012
David Geffen School of Medicine at UCLA, Los Angeles 5368361, California 5332921
Status
Address
David Geffen School of Medicine at UCLA
Los Angeles 5368361, California 5332921, 90005-1752
UCSF Benioff Children s Hospital, Oakland 5378538, California 5332921
Status
Address
UCSF Benioff Children s Hospital
Oakland 5378538, California 5332921, 94609
Rady Children s Hospital, San Diego 5391811, California 5332921
Status
Address
Rady Children s Hospital
San Diego 5391811, California 5332921, 92123
Aurora 5412347, Colorado 5417618
Status
Address
University of Colorado School of Medicine
Aurora 5412347, Colorado 5417618, 80045
Connecticut Childrens Medical Cntr, Hartford 4835797, Connecticut 4831725
Status
Address
Connecticut Childrens Medical Cntr
Hartford 4835797, Connecticut 4831725, 06106
University of Chicago Medical Center, Chicago 4887398, Illinois 4896861
Status
Address
University of Chicago Medical Center
Chicago 4887398, Illinois 4896861, 60637
Minnesota Epilepsy Group, Saint Paul 5045360, Minnesota 5037779
Status
Address
Minnesota Epilepsy Group
Saint Paul 5045360, Minnesota 5037779, 55102
Atlantic Health Systems, Morristown 5101427, New Jersey 5101760
Status
Address
Atlantic Health Systems
Morristown 5101427, New Jersey 5101760, 07962
Cinn Children Hosp Medical Center, Cincinnati 4508722, Ohio 5165418
Status
Address
Cinn Children Hosp Medical Center
Cincinnati 4508722, Ohio 5165418, 45229-3039
Oregon Health Sciences University, Portland 5746545, Oregon 5744337
Status
Address
Oregon Health Sciences University
Portland 5746545, Oregon 5744337, 97239
Childrens Hospital of Philadelphia, Philadelphia 4560349, Pennsylvania 6254927
Status
Address
Childrens Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, 19104
Texas Scottish Rite Hos for Child, Dallas 4684888, Texas 4736286
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