Maintenance Therapy of the Effects of Donepezil-iGaLa Combined Therapy in Post-Stroke Chronic Aphasia: Identification of Predictive Biomarkers of Efficacy.

Status Not authorised · 1 EU/EEA countries · 1 sites · Protocol Don-iGALA

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Not authorised

Participants planned 12

Countries 1

Sites 1

Chronic post-stroke aphasia.

Sponsor: Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Decision date (initial): 2025-02-25
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

CTIS Part I — objectives, methods, condition coding

Chronic post-stroke aphasia.

Sponsor organisations, regulatory contacts, third parties

Sponsor organisation: Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Address: Calle De Severo Ochoa 35, Parque Tecnologico De Andalucia Parque Tecnologico De Andalucia
City: Malaga
Postcode: 29590
Country: Spain

Organisation: Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Contact name: Rocío Moreno / Elvira Bonilla

Organisation: Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Contact name: Rocío Moreno / Elvira Bonilla

1 EU/EEA country · 1 investigational sites

Country	MS status	Planned subjects	Sites
Spain	Not authorised	12	1
Rest of world	—	0	—

1 site · Not authorised

Hospital Universitario Virgen De La Victoria

UGC Neurología y Neurofisiología, Calle Del Arroyo Teatinos Sn, 29010, Malaga

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-06	Spain	Not acceptable 2025-02-24	2025-02-25