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, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Taiwan, Thailand, Turkey, 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, Arizona
Status
Address
TGen APNNA
Phoenix, Arizona, 85012
David Geffen School of Medicine at UCLA, Los Angeles, California
Status
Address
David Geffen School of Medicine at UCLA
Los Angeles, California, 90005-1752
UCSF Benioff Children s Hospital, Oakland, California
Status
Address
UCSF Benioff Children s Hospital
Oakland, California, 94609
Rady Children s Hospital, San Diego, California
Status
Address
Rady Children s Hospital
San Diego, California, 92123
Aurora, Colorado
Status
Address
University of Colorado School of Medicine
Aurora, Colorado, 80045
Connecticut Childrens Medical Cntr, Hartford, Connecticut
Status
Address
Connecticut Childrens Medical Cntr
Hartford, Connecticut, 06106
University of Chicago Medical Center, Chicago, Illinois
Status
Address
University of Chicago Medical Center
Chicago, Illinois, 60637
Minnesota Epilepsy Group, Saint Paul, Minnesota
Status
Address
Minnesota Epilepsy Group
Saint Paul, Minnesota, 55102
Atlantic Health Systems, Morristown, New Jersey
Status
Address
Atlantic Health Systems
Morristown, New Jersey, 07962
Cinn Children Hosp Medical Center, Cincinnati, Ohio
Status
Address
Cinn Children Hosp Medical Center
Cincinnati, Ohio, 45229-3039
Oregon Health Sciences University, Portland, Oregon
Status
Address
Oregon Health Sciences University
Portland, Oregon, 97239
Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania
Status
Address
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Texas Scottish Rite Hos for Child, Dallas, Texas
Status
Address
Texas Scottish Rite Hos for Child
Dallas, Texas, 75219
Texas Childrens Hospital, Houston, Texas
Status
Address
Texas Childrens Hospital
Houston, Texas, 77030
International Sites
Novartis Investigative Site, Randwick, New South Wales, Australia
Status
Address
Novartis Investigative Site
Randwick, New South Wales, 2031
Novartis Investigative Site, Nedlands, Western Australia, Australia
Status
Address
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site, Brussel, Belgium
Status
Address
Novartis Investigative Site
Brussel, , 1090
Novartis Investigative Site, Bruxelles, Belgium
Status
Address
Novartis Investigative Site
Bruxelles, , 1200
Novartis Investigative Site, Gent, Belgium
Status
Address
Novartis Investigative Site
Gent, , 9000
Novartis Investigative Site, Leuven, Belgium
Status
Address
Novartis Investigative Site
Leuven, , 3000
Novartis Investigative Site, Vancouver, British Columbia, Canada
Status
Address
Novartis Investigative Site
Vancouver, British Columbia, V6H 3V4
Novartis Investigative Site, Cali, Valle Del Cauca, Colombia
Status
Address
Novartis Investigative Site
Cali, Valle Del Cauca, 760012
Novartis Investigative Site, Amiens, France
Status
Address
Novartis Investigative Site
Amiens, , 80054
Novartis Investigative Site, Bron Cedex, France
Status
Address
Novartis Investigative Site
Bron Cedex, , 69677
Novartis Investigative Site, Lille, France
Status
Address
Novartis Investigative Site
Lille, , 59037
Novartis Investigative Site, Marseille, France
Status
Address
Novartis Investigative Site
Marseille, , 13885
Novartis Investigative Site, Strasbourg, France
Status
Address
Novartis Investigative Site
Strasbourg, , 67000
Novartis Investigative Site, Budapest, Hungary
Status
Address
Novartis Investigative Site
Budapest, , 1145
Novartis Investigative Site, Bari, BA, Italy
Status
Address
Novartis Investigative Site
Bari, BA, 70124
Novartis Investigative Site, Bologna, BO, Italy
Status
Address
Novartis Investigative Site
Bologna, BO, 40139
Novartis Investigative Site, Pavia, PV, Italy
Status
Address
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site, Roma, RM, Italy
Status
Address
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site, Siena, SI, Italy
Status
Address
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site, Okayama-city, Okayama, Japan
Status
Address
Novartis Investigative Site
Okayama-city, Okayama, 700-8558
Novartis Investigative Site, Suita, Osaka, Japan
Status
Address
Novartis Investigative Site
Suita, Osaka, 565 0871
Novartis Investigative Site, Shizuoka-city, Shizuoka, Japan
Status
Address
Novartis Investigative Site
Shizuoka-city, Shizuoka, 420-8688
Novartis Investigative Site, Osaka, Japan
Status
Address
Novartis Investigative Site
Osaka, , 534-0021
Novartis Investigative Site, Seoul, Korea, Republic of
Status
Address
Novartis Investigative Site
Seoul, , 03080
Novartis Investigative Site, Seoul, Korea, Republic of
Status
Address
Novartis Investigative Site
Seoul, , 03722
Novartis Investigative Site, Seoul, Korea, Republic of
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