A Multicentric, Drug-Repositioning, Self Controlled Case Series (SCCS) Clinical Trial to Evaluate the Efficacy and Safety of Perampanel in Improving Behavioral Symptoms and Increasing the Quality of Life in Patients with White-Sutton syndrome (POGZ-Related Disorder)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520611-14-00

Acronym

5MILLE_CT1

Enrollment

Registered

2025-02-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

White-Sutton syndrome (POGZ-Related Disorder)

Brief summary

Evaluation of differences in total CBCL scores, administered before (at baseline) and at month 6, during Perampanel intake at minimum dosage

Detailed description

Evaluation of differences in scores of all neuropsychological scales administered before (at baseline) and during (at month 12 or 18) Perampanel intake. Recording of: - Medical history; - Clinical features; - Pharmacological history; - Physical examination; - Instrumental evaluation; - Neuropsychological assessment

Interventions

DRUGFycompa 4 mg film-coated tablets

DRUGFycompa 2 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Evaluation of differences in total CBCL scores, administered before (at baseline) and at month 6, during Perampanel intake at minimum dosage	—

Secondary

Measure	Time frame
Evaluation of differences in scores of all neuropsychological scales administered before (at baseline) and during (at month 12 or 18) Perampanel intake. Recording of: - Medical history; - Clinical features; - Pharmacological history; - Physical examination; - Instrumental evaluation; - Neuropsychological assessment	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026