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Clinical efficacy analysis of perampanel in patients with epilepsy comorbid sleep disorders

Clinical efficacy analysis of perampanel in patients with epilepsy comorbid sleep disorders

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093593
Enrollment
Unknown
Registered
2024-12-09
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy comorbidities sleep disorders

Interventions

Patients with epileptic comorbidities with sleep disorders who had not previously taken antiepileptic drugs:The initial dose of Perampanel was 2mg/ night and increased to 4mg/ night after 2 weeks. Pat
Epilepsy comorbidities sleep disorder patients who had previously taken an antiepileptic drug and had seizures that were not controlled for nearly a month:The initial dose of Perampanel was 2mg/ night
Epilepsy comorbidities patients with sleep disorders who had previously taken two antiepileptic drugs and had seizures that were not controlled for nearly a month:The initial dose of Perampanel was 2m
Epilepsy comorbidities sleep disorder patients who had previously taken three antiepileptic drugs and had seizures that were not controlled for nearly a month:The initial dose of Perampanel was 2mg/ n

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for epilepsy of the International League against Epilepsy (ILAE) in 2017, and meet the diagnostic criteria of the International Classification of Sleep Disorders, third edition; 2. Age 14-60 years old, education level can complete the relevant examination; 3. Chinese handedness was rated as right-handedness; 4. no other neurological diseases, no family history of genetic disease; 5. Based on 1 month before the application of pirampanel, the frequency of seizures could not be controlled, and the frequency of seizures was two or more times; 6. Treatment with other fixed antiepileptic drugs plus pirampanil alone lasted for three months or more; 7. The subject or guardian voluntarily agrees to participate in this study and can provide complete case data.

Exclusion criteria

Exclusion criteria: 1. Progressive central nervous system diseases, serious heart, lung, liver, kidney diseases; 2. Taking immunosuppressants, central nervous system inhibitors, sleeping pills and other drugs that may affect sleep; Individuals with unstable recurrent affective disorder who are using antipsychotics or have a mental illness or a suicide attempt within 1 year prior to enrollment; 3. Women who are pregnant, breastfeeding and do not take contraceptive measures; 4. People with lactose intolerance, lactose deficiency or rare genetic diseases such as glucose-lactose absorption disorder; 5. Allergic to the drug or ingredient; 6. Patients with severe sleep disorders;

Design outcomes

Primary

MeasureTime frame
polysomnography (PSG);Pittsburgh Sleep Quality Index Scale;Insomnia Severity Index Scale;Epworth Sleepiness Scale;Hamilton Anxiety Scale;Hamilton Depression Scale;Difference in seizure frequency at 1, 2, 3 months post-medication administration from pre-treatment baseline data;Drug side effects;

Countries

China

Contacts

Public ContactXu Zucai

Affiliated Hospital of Zunyi Medical University

docxzc@126.com+86 133 6866 3217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026