Parkinson DiseaseNCT07145190
SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment
An observational study of Parkinson Disease, run by Bial - Portela C S.A. at 12 sites in Germany.
Trial summary
The purpose of the study is to generate real-world evidence data for the on-demand treatment with SL-APO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- SL-APO
- How many people
- 90 participants
- Where
- 12 sitesGermany
- Study dates
- 27 Aug 2025to Feb 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients experiencing OFF symptoms which cannot be managed by oral anti-PD medication. For clarification, patients who have previously been exposed to apomorphine can also be included in the study.
Who may be able to join
- The patient is ≥ 18 years of age.
- The patient has a clinical diagnosis of idiopathic Parkinson's disease.
- The patient will initiate SL-APO for the treatment of OFF episodes according to the SmPC.
- The patient is not currently on titration or maintenance dose for SL-APO.
- The patient has provided written informed consent to participate in this study.
Who cannot join
- The patient is participating in a clinical trial with an investigational drug.
- The patient has presented with dementia or evidence of cognitive decline as determined by the investigator.
- The patient has a history of psychotic disorder.
- The patient presents any other contraindication according to the SL-APO SmPC.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Germany12 sites, 11 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation
Berlin, 10117
Patricia Krause, Dr. med., patricia.krause@charite.de
- Suspended
Alexianer St. Joseph Berlin-Weißensee GmbH
Berlin, 13088
- Recruiting
Praxis für Neurologie
Berlin, 15366
Martin Delf, Dr. med., 03342422930, dr.delf@neuroprax.de
- Not yet recruiting
Katholisches Klinikum Bochum gGmbH, Universitätsklinikum St.Josef-Hospital, Klinik für Neurologie
Bochum, 44791
Siegfried Muhlack, Prof. Dr., 0234509-0, siegfried.muhlack@rub.de
- Recruiting
UNIVERSITÄTSKLINIKUM FREIBURG - Neurozentrum Klinik für Neurologie und Neurophysiologie im Neurozentrum
Freiburg im Breisgau, D-79106
Michel Rijntjes, Prof Dr med, 076127053570
- Recruiting
Praxis für Neurologie und Psychiatrie
Fulda, 36037
Fabian Sprengel, Dr., info@neuro-fulda.de
- Recruiting
Klinik am Tharandter Wald
Hetzdorf, 09633
Peter Themann, Dr., 03520927711, themann@reha-hetzdorf.de
- Recruiting
Klinik für Neurologie und Neurologische Frührehabilitation
Osnabrück, 49076
Tobias Warnecke, Prof. Dr., 05414056501, tobias.warnecke@klinikum-os.de
- Recruiting
Die Nerven Docs
Siegen, 57072
Markus Diedrichs, 027152455, m.diedrichs@neurologiesiegen.de
- Recruiting
Neurologische Klinik Sorpesee
Sundern, 59846
Pan-Montojo Puga, Prof. Dr., 02935807336, francisco.pan-montojo@klinik-sorpesee.de
- Recruiting
Praxis für Neurologie und Geriatrie
Ulm, 89073
Jan Kassubek, Prof Dr med, 073166400, jan.kassubek@uni-ulm.de
- Recruiting
Neurologie am Funkerberg
Wusterhausen, 15711
Andreas Funke, Dr. med., 01709095741
About this study
Official title: SL-APO in the Treatment of Patients With Parkinson's Disease: a Real-world Evidence Study to Identify Titration and Usage Schemes - SL-START
The purpose of the study is to generate real-world evidence data for the on-demand treatment with SL-APO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.
Read the detailed description
This study is a prospective, observational, real-word evidence study. It is a non-interventional study according to article 2(4) of the Clinical Trials Regulation. Visits are documented as they occur in the routine of the practice or PD clinic.
The medical evaluation that leads to a treatment plan for the patient is not part of this study. The treatment plan may not include SL-APO. This study protocol becomes relevant only after unbiased prescription of SL-APO. Under no circumstances will access to treatment be contingent upon participation in the study. No additional procedures or examinations are required besides the ones already performed per local medical practice.
Patients who will initiate SL-APO according to the SmPC are potential study patients. After the patient's consent to participate in the study, the study starts with the baseline visit at the site (dark blue icon). The tolerance and efficacy of 10 mg SL-APO is tested for a patient in the OFF-state. In case of an insufficient "ON"-response of the first 10 mg dose, dose finding continues with titration at home (light blue house). The Titration follow-up (FU) takes place during the dose finding phase preferably when the patient has reached the preferred dose. The Titration FU can take place as a call or on-site. If a patient is not in the optimal dose during the Titration FU, they will be called again, as per their practice routine. Note, the only data collected from the Titration FU is if the optimal dose according to the HCP has been reached (and the date of the call). Patients will keep a Patient Titration Diary from the baseline visit to the end of titration. The diary entries are started from the 2nd intake of SL-APO. This is regardless of whether the intake takes place at home or in the clinical environment. Patients will keep a Patient Maintenance Diary after the end of titration until the end of the study. For at least the first 7 days and a minimum of 10 intakes, the Patient Maintenance Diary is kept daily, followed by a weekly entry. At 3 and 6 months, FU visits take place at the site. The 6-month FU visit marks the end of the study. The Investigator will decide if patients should continue to be prescribed the maintenance dose after the end of the trial.
- Conditions
- Parkinson Disease
- Being tested
- SL-APO
- Keywords
- Kynmobi, SL-APO
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL-APODrug
Also called Kynmobi
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.
| Study group | Role | What they receive |
|---|---|---|
| SL-START | SL-APO is available as a treatment initiation pack, containing two sublingual films of each strength (total of 30 films). The treatment initiation pack is usually used at the start of treatment to find an effective and tolerable dose. Depending on the patient response, not all doses in this pack may be needed. Receives: Drug: SL-APO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the most frequent dose used after dose-adjustment
The purpose of the study is to generate real-world evidence data for the on-demand treatment with SLAPO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start27 Aug 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Kassubek, Prof Dr med, Principal investigator, Praxis für Neurologie und Geriatrie (Ulm)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145190
- Sponsor's protocol ID
- BIA-KYNMB-401
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SL-APO in the Treatment of Patients With Parkinson's Disease: a Real-world Evidence Study to Identify Titration and Usage Schemes - SL-START
- ClinicalTrials.gov ID
- NCT07145190
- Acronym / sponsor ID
- BIA-KYNMB-401
- Conditions
- Parkinson Disease
- Keywords
- Kynmobi, SL-APO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to generate real-world evidence data for the on-demand treatment with SL-APO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.
Detailed description
This study is a prospective, observational, real-word evidence study. It is a non-interventional study according to article 2(4) of the Clinical Trials Regulation. Visits are documented as they occur in the routine of the practice or PD clinic.
The medical evaluation that leads to a treatment plan for the patient is not part of this study. The treatment plan may not include SL-APO. This study protocol becomes relevant only after unbiased prescription of SL-APO. Under no circumstances will access to treatment be contingent upon participation in the study. No additional procedures or examinations are required besides the ones already performed per local medical practice.
Patients who will initiate SL-APO according to the SmPC are potential study patients. After the patient's consent to participate in the study, the study starts with the baseline visit at the site (dark blue icon). The tolerance and efficacy of 10 mg SL-APO is tested for a patient in the OFF-state. In case of an insufficient "ON"-response of the first 10 mg dose, dose finding continues with titration at home (light blue house). The Titration follow-up (FU) takes place during the dose finding phase preferably when the patient has reached the preferred dose. The Titration FU can take place as a call or on-site. If a patient is not in the optimal dose during the Titration FU, they will be called again, as per their practice routine. Note, the only data collected from the Titration FU is if the optimal dose according to the HCP has been reached (and the date of the call). Patients will keep a Patient Titration Diary from the baseline visit to the end of titration. The diary entries are started from the 2nd intake of SL-APO. This is regardless of whether the intake takes place at home or in the clinical environment. Patients will keep a Patient Maintenance Diary after the end of titration until the end of the study. For at least the first 7 days and a minimum of 10 intakes, the Patient Maintenance Diary is kept daily, followed by a weekly entry. At 3 and 6 months, FU visits take place at the site. The 6-month FU visit marks the end of the study. The Investigator will decide if patients should continue to be prescribed the maintenance dose after the end of the trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SL-START | – | Drug: SL-APOSL-APO is available as a treatment initiation pack, containing two sublingual films of each strength (total of 30 films). The treatment initiation pack is usually used at the start of treatment to find an effective and tolerable dose. Depending on the patient response, not all doses in this pack may be needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients experiencing OFF symptoms which cannot be managed by oral anti-PD medication. For clarification, patients who have previously been exposed to apomorphine can also be included in the study.
Key inclusion criteria (5 listed)
- The patient is ≥ 18 years of age.
- The patient has a clinical diagnosis of idiopathic Parkinson's disease.
- The patient will initiate SL-APO for the treatment of OFF episodes according to the SmPC.
- The patient is not currently on titration or maintenance dose for SL-APO.
- The patient has provided written informed consent to participate in this study.
Key exclusion criteria (4 listed)
- The patient is participating in a clinical trial with an investigational drug.
- The patient has presented with dementia or evidence of cognitive decline as determined by the investigator.
- The patient has a history of psychotic disorder.
- The patient presents any other contraindication according to the SL-APO SmPC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SL-APOAlso: KynmobiPatients 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. | Drug | SL-START |
Primary outcome
Identify the most frequent dose used after dose-adjustment
Time frame: Up to 6 months
The purpose of the study is to generate real-world evidence data for the on-demand treatment with SLAPO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Kassubek, Prof Dr med principal investigator
Praxis für Neurologie und Geriatrie (Ulm)
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Bial - Portela C S.A. at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruben Arnelas (+351229866100, clinical.trials@bial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the most frequent dose used after dose-adjustment (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.