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NCT05823168
Seizures and Traumatic Brain Injury Rehabilitation
trial testing Antiepileptic Drug in Seizures in 84 participants. Completed in 14 January 2025.
31 December 2022
Quick facts
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 84 |
| Start date | 1 January 2021 |
| Primary completion | 31 December 2022 |
| Estimated completion | 14 January 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Antiepileptic Drug — full drug profile →
Conditions studied
- Seizures — all drugs for Seizures →
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Who can join
Adults 18 to 85, any sex, with Seizures or Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
post-traumatic seizures (PTS) are a common and debilitating complication of traumatic brain injury (TBI) and could have harmful impact on patient disabilty and rehabilitation outcome. In this multicentric prospective observational study we aimed to evaluate the role on functional outcome of patients admitted to neurorehabilitation unit afther traumatic brain injury of: * newly occurring seizures * prescription of antiepileptic prophylactic therapy The inclusion criteria were the following: 1) age ≥ 18; 2) diagnosis of TBI on presentation; 3) admission to a hospital emergency department within 24 h of injury; 4) admission within one month from the injury to the rehabilitation unit to continue clinical care and rehabilitation program; 5) up to 6 months of observation in rehabilitation setting. Were collected the following variables: gender, medical history, age at occurrence of injury, injury characteristics, fracture site, presence of penetrating TBI, presence of subarachnoid haemorrhage, associated neurosurgical procedures (craniotomy, cranioplasty), neurologic and functional assessments, brain imaging, occurrence of seizure, presence and type of anticonvulsant therapy, death during hospitalization. The investigator analysed through logistic regression variables predictors of risk occurrence of seizure, and neurological and functional outcome, respectively assessed with the Glasgow Coma Scale (GCS) and the Functional Independence Measure (FIM).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05823168
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Seizures
Currently open trials in the same condition.
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Other Istituti Clinici Scientifici Maugeri SpA trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05823168 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituti Clinici Scientifici Maugeri SpA
- Last refreshed: 14 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05823168.
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