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NCT03457961
Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong
trial testing Perampanel in Focal Epilepsy in 80 participants. Status unknown.
1 July 2021
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 23 July 2016 |
| Primary completion | 1 July 2021 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Perampanel (PERAMPANEL) — full drug profile →
Conditions studied
- Focal Epilepsy — all drugs for Focal Epilepsy →
- Generalized Epilepsy — all drugs for Generalized Epilepsy →
- Partial Seizures, Simple — all drugs for Partial Seizures, Simple →
Sponsor
Chinese University of Hong Kong
Who can join
12 and older, any sex, with Focal Epilepsy or Generalized Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Epilepsy is a chronic neurological disease which affects approximately 70,000 patients in Hong Kong and 50 billion people worldwide. Among these patients one-third remained unresponsive to antiepileptic agents. Continual drug manipulation is an essential therapeutic option for these patients with refractory epilepsy. In particular, rational polytherapy has become the mainstay of treatment for the sub-group of patients who have failed two or more antiepileptic drugs (AEDs). A substantial amount of research has shown that N-methyl-D-aspartate receptors (NMDA) may play a key role in the pathophysiology of several neurological diseases, including epilepsy. Animal models of epilepsy and clinical studies demonstrate that NMDA receptors activity and expression can be altered in association with epilepsy and particularly in some specific seizure types. NMDA receptor antagonists have been shown to have antiepileptic effects in both clinical and preclinical studies. There is some evidence that conventional antiepileptic drugs may also affect NMDA receptor function. Aims: To investigate the medium to long-term effects of AMPA/NMDA receptor antagonist in an Asian cohort as there is a relative lack of clinical data in this population To explore the efficacy of AMPA/NMDA receptor antagonist in patients with partial onsets seizures that may secondarily generalize and the specific side effects of AMPA/NMDA receptor antagonist in relation to behavioral problems. Methods: A semi-prospective design is adopted to recruit patients who are indicated and started on AMPA/NMDA receptor antagonist aged 12 or above in Hong Kong. This study will collect information about demographic details, medical history and seizure information. Assessment of seizure frequency is based on seizure diary and interviews with family members. Physical examination, electrocardiogram and other medical information relevant to the follow-up of the patient will be collected.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03457961
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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 NCT03457961 (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 Chinese University of Hong Kong
- Last refreshed: 27 August 2020
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/NCT03457961.
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