Trial document




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  DRKS00017811

Trial Description

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Title

Register on the prognosis of acute symptomatic seizures

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Trial Acronym

PROSE register

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Acute symptomatic seizures are symptoms of an acute disturbance of the brain which can result directly from a damage to the brain itself (e.g., traumatic brain injury) or indirectly from conditions that affect the whole organism (e.g., hypoglycaemia).

Depending on the individual situation, it may be reasonable to apply or not to apply substances which lower the risk of further seizures ("antiepileptic drugs") for a short period of time (i.e., during the "acute phase"). As the risk of subsequent unprovoked seizures is low (10-years risk: <20%), a long-term antiepileptic treatment is usually not necessary.

However, until now, evidence on the risk of subsequent unprovoked seizures is limited, and relevant data were acquired several decades ago. With the aid of the PROSE register, we aim at, firstly, determining the risk of seizure relapse after an acute symptomatic first seizure that were treated according to current clinical guidelines. Secondly, we aim at identifying clinical variables associated with a higher or lower risk of seizure relapse.

The results of the PROSE register will help clinicians in the future to give tailored therapeutic recommendations to their patients affected by acute symptomatic epileptic seizures.

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Brief Summary in Scientific Language

Acute symptomatic seizures (ASS) are symptoms of an acute disturbance of brain function. Following an operational definition, ASS occur in close temporal relationship to specific types of acute brain injury or systemic conditions (Beghi et al., Epilepsia 2010). ASS are a particularly frequent phenomenon in neurological and neurosurgical intensive care medicine. According to a significant study published in 2009 (Hesdorffer et al., Epilepsia), the cumulative 10-years risk of unprovoked seizure relapse after an acute symptomatic seizure is 19% (12-months risk: 13%).

Following this finding, current clinical guidelines recommend to treat acute symptomatic seizures with antiepileptic drugs for a short time only (during the "acute phase") or not at all (see AWMF S1 guideline on first epileptic seizures and epilepsy in adults, 2017, or ESO guideline, European Stroke Journal 2017).

However, evidence for this recommendation is low as it is mainly based on the study mentioned above. Patients included in that study had their index seizures between 1955 and 1984, and it remains unclear as to whether and at what time they were treated with antiepileptic drugs. Clinical experience shows that patients with ASS are frequently treated far longer than clinically necessary (Vorderwülbecke et al., J Neurol 2018).

The PROSE register aims at following up on patients with ASS but without long-term antiepileptic drug treatment. The expected results of the study shall demonstrate that (or: in which cases) antiepileptic drugs can be discontinued safely before a patient is discharged from the intensive care unit, without a relevant risk of unprovoked seizure relapse.

Most ASS result from a structural cause (Beleza, Neurologist 2012), and the risk of seizure relapse in patients with ASS due to structural brain lesions is of special interest for many neurologists. Therefore, the PROSE register especially focuses on the subgroup of ASS with structural aetiology.

Participants will be followed up for at least 12 months to verify or falsify the following primary hypothesis: After an acute symptomatic first epileptic seizure of structural aetiology (e.g, cerebrovascular, traumatic), the 12-months risk for unprovoked seizure relapse is not higher than 25%, even if patients were not treated with antiepileptic drugs or treated for a short period only.

The secondary hypothesis reads: Acute symptomatic first seizures due to structural CNS lesions have a higher risk for unprovoked seizure relapse than acute symptomatic first seizures due to another aetiology (e.g., metabolic).

This study is coordinated by the research group on Clinical and Experimental Epileptology at Charité - Universitätsmedizin Berlin and is conducted as a multicentre study within the IGNITE! study network (Initiative of German Neuro-Intensive Trial Engagement).

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Organizational Data

  •   DRKS00017811
  •   2019/08/13
  •   [---]*
  •   yes
  •   Approved
  •   EA2/016/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G40.5 -  Special epileptic syndromes
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Interventions/Observational Groups

  •   After an acute symptomatic first seizure, participants will be followed up for 12 months and interviewed regarding seizure relapse, seizure related hospitalisation, antiepileptic medication, and overall functional outcome.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Occurrence and time point of a first unprovoked epileptic seizure relapse within 12 months after the acute symptomatic first seizure.

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Secondary Outcome

Occurrence and time point of additional acute symptomatic seizures; initiation of an antiepileptic medication; seizure related rehospitalisation; overall functional outcome (Modified Rankin Score).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/09/18
  •   115
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Acute symptomatic first epileptic seizure

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Exclusion Criteria

Status epilepticus

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Addresses

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    • Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Epilepsie-Zentrum Berlin-Brandenburg
    • Mr.  Prof. Dr. med.  Martin  Holtkamp 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Neurologie
    • Mr.  Dr. med.  Bernd  Vorderwülbecke 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Neurologie
    • Ms.  Dr. med.  Julia  Nichtweiß 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.