Trial record 15 of 36 for:    "tuberous sclerosis"

Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex (EPISTOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Memorial Health Institute, Poland
Sponsor:
Collaborators:
University of Rome Tor Vergata
Institut National de la Santé Et de la Recherche Médicale, France
Vrije Universiteit Brussel
General University Hospital, Prague
Charite University, Berlin, Germany
Katholieke Universiteit Leuven
Medical University of Vienna
Rudolf Magnus Institute – University of Utrecht
Brigham and Women's Hospital
Information provided by (Responsible Party):
Sergiusz Jozwiak, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:
NCT02098759
First received: March 25, 2014
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The primary objective of clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC.

Secondary objective of the clinical part of EPISTOP is to compare the effects of standard antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.


Condition Intervention
TSC
Tuberous Sclerosis Complex
Epilepsy
Device: epilepsy early diagnosis protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex

Resource links provided by NLM:


Further study details as provided by Children's Memorial Health Institute, Poland:

Primary Outcome Measures:
  • number of patients with epilepsy [ Time Frame: at 24 month of life ] [ Designated as safety issue: No ]
    Full analysis set comprises all patients participating in the study, including the control group. This set will be divided into subsets: control group, TSC patients with epilepsy, and TSC patients with no epilepsy. Among TSC patients with epilepsy, patients with well-controlled seizures and patients with drug-resistant epilepsy will be identified. In full analysis set the blood biomarkers will be analysed. Clinical analysis set will comprise of all TSC infants enrolled in the study and the clinical biomarkers of epileptogenesis (neuroimaging, vEEG, data from medical history) will be analysed in this set. Treatment analysis set will comprise of infants participating in the randomized part of the study and the efficacy of antiepileptic treatment in respect to the point of epilepsy diagnosis (electroencephalographic epileptiform discharges onset in group A and clinical seizures onset in group B) will be assessed in this set.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epilepsy early diagnosis
Infants that have epileptiform discharges on vEEG and no clinical seizures, if their parents/caregivers give consent, will enter the randomized part of the study. Those children will be randomized into two groups: group A will be diagnosed as having epilepsy after subclinical (electroencephalographic) epileptiform discharges, and the patients in group B will be diagnosed as epileptic after clinical seizures appear. All infants diagnosed with epilepsy will receive standard therapy with recommended first line antiepileptic drug starting from the day of diagnosis.
Device: epilepsy early diagnosis protocol
Infants that have epileptiform discharges on vEEG and no clinical seizures, if their parents/caregivers give consent, will enter the randomized part of the study. Those children will be randomized into two groups: group A will be diagnosed as having epilepsy after subclinical (electroencephalographic) epileptiform discharges (based on epilepsy early diagnosis protocol), and the patients in group B will be diagnosed as epileptic after clinical seizures appear. All infants diagnosed with epilepsy will receive standard therapy with recommended first line antiepileptic drug starting from the day of diagnosis.
Experimental: standard epilepsy diagnosis
Infants that have epileptiform discharges on vEEG and no clinical seizures, if their parents/caregivers give consent, will enter the randomized part of the study. Those children will be randomized into two groups: group A will be diagnosed as having epilepsy after subclinical (electroencephalographic) epileptiform discharges, and the patients in group B will be diagnosed as epileptic after clinical seizures appear. All infants diagnosed with epilepsy will receive standard therapy with recommended first line antiepileptic drug starting from the day of diagnosis.
Device: epilepsy early diagnosis protocol
Infants that have epileptiform discharges on vEEG and no clinical seizures, if their parents/caregivers give consent, will enter the randomized part of the study. Those children will be randomized into two groups: group A will be diagnosed as having epilepsy after subclinical (electroencephalographic) epileptiform discharges (based on epilepsy early diagnosis protocol), and the patients in group B will be diagnosed as epileptic after clinical seizures appear. All infants diagnosed with epilepsy will receive standard therapy with recommended first line antiepileptic drug starting from the day of diagnosis.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

Inclusion criteria for TSC patients:

  • male or female infants with a definite diagnosis of TSC (Roach criteria; Roach 1998 or DNA confirmed),
  • age up to 4 months at the moment of enrolment,
  • no clinical seizures seen by caregivers or on baseline videoEEG recording,
  • written informed consent of caregivers. It is possible to give consent for the observational part of the study only. In this case, the child will not enter the randomized part of the study.

Inclusion criteria for the control group:

  • male or female infants who have undergone routine MRI for reasons other than epilepsy and brain tumor or cortical defects,
  • age up to 24 months at the moment of study entry,
  • written informed consent of caregivers. Exclusion criteria

Exclusion criteria for TSC patients:

  • any type of seizures observed till baseline visit,
  • antiepileptic treatment at or prior to study entry,
  • contraindications to MRI,
  • any severe and/or uncontrolled medical condition that is considered by the investigator as possibly affecting the EPISTOP analyses or procedures.

Exclusion criteria for the control group:

  • any sign or symptom suggesting TSC diagnosis,
  • any type of seizures observed at study entry,
  • antiepileptic treatment at study entry,
  • history of seizures, with the exception of febrile seizures,
  • any severe and/or uncontrolled medical condition that is considered by the investigator as possibly affecting the EPISTOP analyses or procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098759

Contacts
Contact: Sergiusz Jozwiak, Md, PhD 0048228157404 s.jozwiak@czd.pl
Contact: Katarzyna Kotulska-Jozwiak, Md, PhD 0048228157405 k.kotulska@czd.pl

Locations
Austria
Medizinische Universitaet Wien Not yet recruiting
Vienna, Austria
Contact: Martha Feucht, MD, PhD    00431404003805      
Principal Investigator: Martha Feucht, MD, PhD         
Belgium
Vrije Universiteit Brussel Not yet recruiting
Brussels, Belgium
Contact: Anna Jansen, MD, PhD    003224775785      
Principal Investigator: Anna Jansen, MD, PhD         
Katholieke Universiteit Leuven Not yet recruiting
Leuven, Belgium
Contact: Lieven Lagae, MD, PhD    003216343845      
Principal Investigator: Lieven Lagae, MD, PhD         
Czech Republic
Fakultni Nemocnice V Motole Active, not recruiting
Prague, Czech Republic
France
Institut National De La Sante et de la Recherche Medicale Not yet recruiting
Paris, France
Contact: Rima Nabbout, Md, PhD    0033144381536      
Principal Investigator: Rima Nabbout, Md, PhD         
Germany
Charite - Universitaetsmedizin Berlin Not yet recruiting
Berlin, Germany
Contact: Bernhard Weschke, MD, PhD    004930450666617      
Principal Investigator: Bernhard Weschke, MD, PhD         
Italy
Universita Degli Studi Di Roma Tor Vergata Active, not recruiting
Rome, Italy
Netherlands
Universitair Medisch Centrum Utrecht Not yet recruiting
Utrecht, Netherlands
Contact: Floor Jansen, MD, PhD    0031887554341      
Principal Investigator: Floor Jansen, MD, PhD         
Poland
Children's Memorial Health Institute Recruiting
Warsaw, Poland
Contact: Sergiusz Jozwiak, Md, PhD    0048228157404      
Contact: Katarzyna Kotulska-Jozwiak, Md, PhD    0048228157405      
Principal Investigator: Sergiusz Jozwiak, Md, PhD         
Sponsors and Collaborators
Sergiusz Jozwiak
University of Rome Tor Vergata
Institut National de la Santé Et de la Recherche Médicale, France
Vrije Universiteit Brussel
General University Hospital, Prague
Charite University, Berlin, Germany
Katholieke Universiteit Leuven
Medical University of Vienna
Rudolf Magnus Institute – University of Utrecht
Brigham and Women's Hospital
Investigators
Principal Investigator: Seriusz Jozwiak, Md, PhD Children's Memorial Health Institute
  More Information

No publications provided

Responsible Party: Sergiusz Jozwiak, MD, PhD, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier: NCT02098759     History of Changes
Other Study ID Numbers: EPISTOP, 602391
Study First Received: March 25, 2014
Last Updated: April 3, 2014
Health Authority: Poland: Ethics Committee
Czech Republic: Ethics Committee
Italy: Ethics Committee
Germany: Ethics Commission
Austria: Ethikkommission
France: Institutional Ethical Committee
Belgium: Ethics Committee
Netherlands: Independent Ethics Committee

Keywords provided by Children's Memorial Health Institute, Poland:
TSC
tuberous sclerosis complex
epilepsy

Additional relevant MeSH terms:
Tuberous Sclerosis
Epilepsy
Sclerosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Hamartoma
Neoplasms
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development
Nervous System Malformations
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014