Kliinilise uuringu otsus nr RKU-4/31

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

20.05.2024 nr RKU-4/31

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Otsuka Pharmaceutical Development & Commercialization Inc. esitas

20.03.2024 Ravimiametile taotluse ravimi kliinilise uuringu teostamiseks määruse (EL)

536/2014 artikli 5 (1) ja ravimiseaduse (RavS) § 991 lõikes 1 sätestatud tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 2 ja lõike 3 alusel

anda uuringu sponsorile Otsuka Pharmaceutical Development & Commercialization Inc. loa

ravimi kliinilise uuringu läbiviimiseks vastavalt esitatud uuringuplaanile nr 20-AVP-786-306

järgmistel tingimustel:

uuringuplaani number: 20-AVP-786-306 (versioon 3.9 kuupäevaga 13. juuni 2023)

uuringu referentsnumber: 20-049

uuringu nimetus: „A Phase 3, multicenter, randomized, double-blind, placebo-controlled

study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan

hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with

dementia of the Alzheimer’s type“

uuringu sponsor: Otsuka Pharmaceutical Development & Commercialization Inc.

uuritavate arv Eestis: 13

vastutavad uurijad ja uuringukeskused:

- Dr Katrin Gross-Paju, Clinic4U OÜ, Kotka Tn 12 C, 11315 Tallinn, Eesti

- Dr Ülla Linnamägi, Tartu Ülikooli Kliinikum, L. Puusepa tn 8, 50406 Tartu, Eesti

- Dr Kairi Mägi, Marienthali Kliinik OÜ, Kotka Tn 12 C, 11315 Tallinn, Eesti

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

Boris Reznichenko

Otsuka Pharmaceutical Development &

Commercialization Inc.

2440 Research Boulevard

20850-3238 Rockville

AMEERIKA ÜHENDRIIGID

2 (2)

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

20.05.2024 nr RKU-4/31

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor Otsuka Pharmaceutical

Development & Commercialization Inc. on 20.03.2024 to conduct a clinical trial under the

conditions stipulated in Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian

Medicinal Products Act (MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 2 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no 20-AVP-786-306 under the following conditions:

protocol no: 20-AVP-786-306 (Version 3.9, dated June 13, 2023)

full title of the trial: A Phase 3, multicenter, randomized, double-blind, placebo-controlled

study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan

hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with

dementia of the Alzheimer’s type

sponsor of the trial: Otsuka Pharmaceutical Development & Commercialization Inc.

number of subjects in Estonia: 13

principal investigators and study locations:

- Dr Katrin Gross-Paju, Clinic4U OÜ, Kotka Tn 12 C, 11315 Tallinn, Estonia

- Dr Ülla Linnamägi, Tartu University Hospital, L. Puusepa tn 8, 50406 Tartu, Estonia

- Dr Kairi Mägi, Marienthali Kliinik OÜ, Kotka Tn 12 C, 11315 Tallinn, Estonia

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

annulled by the administrative court, he or she may submit a complaint to the Tartu

Boris Reznichenko

Otsuka Pharmaceutical Development &

Commercialization Inc.

2440 Research Boulevard

20850-3238 Rockville

UNITED STATES

2 (2)

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

(digitally signed)

Katrin Kiisk

Director General