SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment

RecruitingOBSERVATIONAL
Enrollment

90

Participants

Timeline

Start Date

August 27, 2025

Primary Completion Date

February 29, 2028

Study Completion Date

February 29, 2028

Conditions
Parkinson Disease
Interventions
DRUG

SL-APO

"Patients should start with a dose of 10 mg SL-APO. Dose initiation should occur when the patient is having an OFF episode. If the patient tolerates the 10 mg dose, and responds adequately (meaning satisfactory motor response within 30 minutes), the maintenance dose should be 10 mg. If the dose is tolerated but the response is insufficient, continue to titrate in 5 mg increments when the patient is having an OFF episode and assess response until an effective and tolerable dose is achieved, up to a maximum of 30 mg per dose and up to five times a day. If an ON response is achieved and if clinically warranted, consider the need to further up-titrate as tolerated to achieve a better ON response. The minimal interval between doses is 2 hours, with no more than one dose of SL-APO per OFF episode."

Trial Locations (12)

10117

NOT_YET_RECRUITING

Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation, Berlin

13088

NOT_YET_RECRUITING

Alexianer St. Joseph Berlin-Weißensee GmbH, Berlin

15366

RECRUITING

Praxis für Neurologie, Berlin

15711

RECRUITING

Neurologie am Funkerberg, Wusterhausen

36037

NOT_YET_RECRUITING

Praxis für Neurologie und Psychiatrie, Fulda

44791

NOT_YET_RECRUITING

Katholisches Klinikum Bochum gGmbH, Universitätsklinikum St.Josef-Hospital, Klinik für Neurologie, Bochum

49076

NOT_YET_RECRUITING

Klinik für Neurologie und Neurologische Frührehabilitation, Osnabrück

57072

NOT_YET_RECRUITING

Die Nerven Docs, Siegen

59846

NOT_YET_RECRUITING

Neurologische Klinik Sorpesee, Sundern

89073

NOT_YET_RECRUITING

Praxis für Neurologie und Geriatrie, Ulm

D-79106

NOT_YET_RECRUITING

UNIVERSITÄTSKLINIKUM FREIBURG - Neurozentrum Klinik für Neurologie und Neurophysiologie im Neurozentrum, Freiburg im Breisgau

09633

NOT_YET_RECRUITING

Klinik am Tharandter Wald, Hetzdorf

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT07145190 - SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment | Biotech Hunter | Biotech Hunter