Parkinson DiseasePhase 2NCT06247410
Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease
A Phase 2 study testing Rotigotine 8Mg/24Hrs Patch in people with Parkinson Disease, run by SocraTec R&D GmbH at 8 sites in Germany.
Trial summary
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of… 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?
- Rotigotine 8Mg/24Hrs Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 8 sitesGermany
- Study dates
- 23 Aug 2021to 30 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- ethnic origin: Caucasian
- age: 18 years or older
- diagnosis of idiopathic Parkinson's disease
- administration of a stable dose of at least 8 mg/24 h rotigotine including use of an 8 mg/24 h patch for at least 2 weeks prior to enrolment
- agreement to refrain from swimming, bathing or using a sauna on the assessment days
- written informed consent obtained, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial
Who cannot join
- Safety concerns
- existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products
- existing and/or history of dermatitis (eczema; excluding seborrheic skin by Parkinson's disease)
- existing and/or history of psoriasis
- existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator's assessment
- history of or current drug or alcohol dependence
Show all 20Show fewer
- existing medical condition or psychiatric condition which, in the opinion of the investigator, could jeopardize or compromise the patient's well-being or ability to participate in this study
- lifetime history of suicide attempt
- suicidal ideation in the past 6 months
- administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the patient
- diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the patient
- contact to persons in foreign risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the patient
- known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the patient
- For female patients with childbearing potential only:
- positive pregnancy test at screening examination
- pregnant or lactating women
- female patients who do not agree to apply highly effective contraceptive methods
- Administrative reasons
- patients suspected or known not to follow instructions
- patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Neuroakademie Alzenau GbR
Alzenau in Unterfranken, Bavaria, 63755
Neurologisches Fachkrankenhaus für Bewegungsstörungen/ Parkinson
Beelitz-Heilstätten, Brandenburg, 14547
Praxis für Neurologie Dr. med. Christian Oehlwein
Gera, Thuringia, 07551
Curiositas ad Sanum Studien- und Beratungs GmbH Innklinikum Haag i.OB
Haag in Oberbayern, Bavaria, 83527
Gertrudis-Klinik Parkinson-Zentrum GmbH
Leun, Hesse, 35638
Curiositas ad Sanum Studien- und Beratungs GmbH
München, Bavaria, 80331
Universitätsklinikum Ulm Neur. Studienzentrale im RKU
Ulm, Baden-Wurttemberg, 89081
Parkinson-Klinik Ortenau GmbH & Co. KG
Wolfach, Baden-Wurttemberg, 77709
About this study
Official title: Comparative, Randomized, Open, Crossover Clinical Trial to Investigate Adhesiveness of a Newly Developed Rotigotine-containing Transdermal Patch in Patients With Parkinson's Disease
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product.
It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.
Read the detailed description
This multi-centre, open, randomized (order of treatments), multiple dose trial will be performed in a 4-period, 2-sequence-crossover design. A washout phase is not needed, i.e. the IMP application of the 2nd study period may take place the day of the IMP removal of the 1st study period (direct switch-over) and so forth.
Patients with a diagnosis of idiopathic Parkinson's disease and a continuous and stable dose of rotigotine (at least 8 mg/24 h) including use of an 8 mg/24 hours patch will be randomized.
In each of the 4 periods 1 patch, either of Test or Reference will be applied, with a release rate of 8 mg/24 h rotigotine each. Each patch will remain applied for 24 h.
Assessment of patch adhesion will be performed 5 min after application of each patch as well as at the end of the application interval prior to removal of the patch.
The clinical trial will be performed as a crossover investigation with intra-individual comparison, thus reducing variability of the patch adhesion parameters, which is supposed to be higher between patients than within an individual patient.
The patients will continue their usual medications and will only replace one 8 mg/24 h rotigotine containing patch per day with the IMPs for the duration of treatment in the clinical trial. In case of prescribed doses above 8 mg/24 h rotigotine, the remaining dose will be provided by Non-Investigational Medicinal Pproducts (NIMPs). Thus, no interruption in the prescribed dose of rotigotine will occur.
- Conditions
- Parkinson Disease
- Being tested
- Rotigotine 8Mg/24Hrs Patch
- Keywords
- Rotigotine, Rotigotine Patch, Patch Adhesion, Local Tolerability
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine 8Mg/24Hrs PatchDrug
Once daily patch application of one Rotigotine 8Mg/24Hrs Patch (Test or Reference) over 4 days
| Study group | Role | What they receive |
|---|---|---|
| Sequence: Reference-Test-Reference-Test (RTRT) | Other | Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with RTRT sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase.
Period 1: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application
Period 2: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application
Period 3: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application
Period 4: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application Receives: Drug: Rotigotine 8Mg/24Hrs Patch |
| Sequence: Test-Refrence-Test-Reference | Other | Once daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with TRTR sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase.
Period 1: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application
Period 2: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application
Period 3: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application
Period 4: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application Receives: Drug: Rotigotine 8Mg/24Hrs Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area.
The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion:
0 = ≥ 90% adhered
- = ≥ 80% adhered
- = ≥ 70% adhered
- = ≥ 60% adhered
- = ≥ 50% adhered
- = < 50% adhered or patch completely off the skin.
Measured: 24 hours
Comparative assessment of patch adhesion properties of the Test vs. Reference product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area.
The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion:
0 = ≥ 90% adhered
- = ≥ 80% adhered
- = ≥ 70% adhered
- = ≥ 60% adhered
- = ≥ 50% adhered
- = < 50% adhered or patch completely off the skin.
Measured: 24 hours
Secondary outcomes (2)
Skin tolerability of Test and Reference based on standardised assessment of Adverse Events of Special Interest
Skin irritation will be assessed for Test/ Reference 30 min after patch removal by trained observers. Skin will be visually checked and palpated. The investigator will decide based on own experience or given specifications, if a skin irritation is to be classified as Adverse Event. Additionally, photos of the skin area will be taken for documentation at all assessment time points. The following symptoms and severity grades will be used for assessment of tolerability at the site:
Dermal response: symptom (severity); erythema (none/ minimal/ mild/ moderate/ severe); papules (none/ discrete/ pronounced); oedema (none/ minimal/ definite); vesicles (none/ non-confluent ≤ 5 mm/ confluent/ non-confluent ≥ 5 mm) Skin reaction spreading beyond site Other effects: none; slightly glazed appearance; markedly glazed appearance; glazing with peeling and cracking; glazing with fissures; film of dried serous exudates covering all or part of the site; small petechial erosions and/or scabs
Measured: 24 hours
Descriptive characterisation of safety and tolerability of the investigational medicinal products (IMPs) in the trial population
Adverse Events (AEs) observed, mentioned upon general questioning, or spontaneously reported will be documented. Adverse Events of Special Interest (AESI): Skin irritation and sensitization symptoms at patch application site Adverse Events will be listed and evaluated descriptively with regard to action taken, frequency, seriousness, intensity, relationship to the IMP, and outcome, as well as period and treatment.
Safety parameters vital signs (BP, pulse rate (PR)): Systolic and diastolic arterial blood pressure will be measured by oscillometry using an automatic non-invasive device.
Abnormal findings during this safety measurements, assessed as clinically relevant by the investigator, will be reported as adverse events and will be followed up and/or treated as medically appropriate.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start23 Aug 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- SocraTec R&D GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- SocraMetrics GmbH, Luye Pharma Group Ltd.
- Responsible party
- Sponsor
- Investigators
- Wolfgang Jost, Prof. Dr med, Principal investigator, Parkinson-Klinik Ortenau GmbH & Co KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247410
- Sponsor's protocol ID
- 1402rot20ct
- Other IDs
- 2021-000867-65
- Status last verified
- Apr 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 May 2024
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Open, Crossover Clinical Trial to Investigate Adhesiveness of a Newly Developed Rotigotine-containing Transdermal Patch in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06247410
- Acronym / sponsor ID
- 1402rot20ct
- Conditions
- Parkinson Disease
- Keywords
- Rotigotine, Rotigotine Patch, Patch Adhesion, Local Tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- SocraTec R&D GmbHUniversity, hospital or other
- Collaborators
- SocraMetrics GmbH, Luye Pharma Group Ltd.
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 7 Feb 2024 (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 investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product.
It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.
Detailed description
This multi-centre, open, randomized (order of treatments), multiple dose trial will be performed in a 4-period, 2-sequence-crossover design. A washout phase is not needed, i.e. the IMP application of the 2nd study period may take place the day of the IMP removal of the 1st study period (direct switch-over) and so forth.
Patients with a diagnosis of idiopathic Parkinson's disease and a continuous and stable dose of rotigotine (at least 8 mg/24 h) including use of an 8 mg/24 hours patch will be randomized.
In each of the 4 periods 1 patch, either of Test or Reference will be applied, with a release rate of 8 mg/24 h rotigotine each. Each patch will remain applied for 24 h.
Assessment of patch adhesion will be performed 5 min after application of each patch as well as at the end of the application interval prior to removal of the patch.
The clinical trial will be performed as a crossover investigation with intra-individual comparison, thus reducing variability of the patch adhesion parameters, which is supposed to be higher between patients than within an individual patient.
The patients will continue their usual medications and will only replace one 8 mg/24 h rotigotine containing patch per day with the IMPs for the duration of treatment in the clinical trial. In case of prescribed doses above 8 mg/24 h rotigotine, the remaining dose will be provided by Non-Investigational Medicinal Pproducts (NIMPs). Thus, no interruption in the prescribed dose of rotigotine will occur.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence: Reference-Test-Reference-Test (RTRT) | Other | Drug: Rotigotine 8Mg/24Hrs PatchOnce daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with RTRT sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase. Period 1: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application Period 2: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application Period 3: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application Period 4: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application |
| Sequence: Test-Refrence-Test-Reference | Other | Drug: Rotigotine 8Mg/24Hrs PatchOnce daily patch application of one patch of Test or Reference over 4 days, i.e. a total of 4 alternating applications with TRTR sequence. Each patch remains applied for 24 h. Treatments may be directly switched without washout phase. Period 1: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application Period 2: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application Period 3: Test: ROT-TDS (8 mg/24 h) 36.8 cm2 transdermal system containing 14.72 mg rotigotine (Luye Pharma AG, Germany), dermal application Period 4: Reference: Neupro® 8 mg/24 h, 40 cm2 transdermal system containing 18 mg rotigotine (UCB Pharma GmbH, Germany), dermal application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ethnic origin: Caucasian
- age: 18 years or older
- diagnosis of idiopathic Parkinson's disease
- administration of a stable dose of at least 8 mg/24 h rotigotine including use of an 8 mg/24 h patch for at least 2 weeks prior to enrolment
- agreement to refrain from swimming, bathing or using a sauna on the assessment days
Key exclusion criteria (20 listed)
- Safety concerns
- existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products
- existing and/or history of dermatitis (eczema; excluding seborrheic skin by Parkinson's disease)
- existing and/or history of psoriasis
- existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator's assessment
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 |
|---|---|---|
| Rotigotine 8Mg/24Hrs PatchOnce daily patch application of one Rotigotine 8Mg/24Hrs Patch (Test or Reference) over 4 days | Drug | Sequence: Reference-Test-Reference-Test (RTRT), Sequence: Test-Refrence-Test-Reference |
Primary outcome
Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
Time frame: 24 hours
Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area. The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion: 0 = ≥ 90% adhered 1. = ≥ 80% adhered 2. = ≥ 70% adhered 3. = ≥ 60% adhered 4. = ≥ 50% adhered 5. = < 50% adhered or patch completely off the skin.
Comparative assessment of patch adhesion properties of the Test vs. Reference product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval
Time frame: 24 hours
Patch adhesion will be assessed for Test/ Reference 5 min and 23 h 55 min after patch application by trained observers. Area(s) detached will be drawn on transparent films of identical size and shape as the patch in question by the trained observer. As suggested by the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), June 2015, patch adhesion will be measured by means of the percentage of area that remains adhered at the end of the dosing interval. Additionally, the patch adhesion will be documented by taking photos at the time point of intended patch adhesion assessment of the patch and surrounding area. The following scores and affiliated percentages for the relative area still in tight contact with the skin will be used in order to quantify the patch adhesion: 0 = ≥ 90% adhered 1. = ≥ 80% adhered 2. = ≥ 70% adhered 3. = ≥ 60% adhered 4. = ≥ 50% adhered 5. = < 50% adhered or patch completely off the skin.
2 secondary outcomes
Skin tolerability of Test and Reference based on standardised assessment of Adverse Events of Special Interest
Time frame: 24 hours
Descriptive characterisation of safety and tolerability of the investigational medicinal products (IMPs) in the trial population
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- 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. This study is not recruiting at the moment.
Wolfgang Jost, Prof. Dr med principal investigator
Parkinson-Klinik Ortenau GmbH & Co KG
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rotigotine 8Mg/24Hrs Patch in people with Parkinson Disease, run by SocraTec R&D GmbH at 8 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of patch adhesion properties of the Test product in patients diagnosed with idiopathic Parkinson's disease at the end of the dosing interval (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 1 May 2024.