Parkinson DiseasePhase 1NCT04183634
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
A Phase 1 study testing Rotigotine TTS (Test) and Neupro (Reference) in people with Parkinson Disease, run by Sandoz at 1 site in Germany.
Trial summary
The objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rotigotine TTS (Test) and Neupro (Reference)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 3 Dec 2019to 16 Mar 2020
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.
Who cannot join
- Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
- History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
- History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
- History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
Read the detailed description
The objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
The following evaluations will be assessed as "yes" or "no":
- Cold flow (dark ring formed around the patch)
- Patch movement/displacement
- Patch wrinkling
- Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.
AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).
As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.
- Conditions
- Parkinson Disease
- Being tested
- Rotigotine TTS (Test), Neupro (Reference)
- Keywords
- adhesiveness
- 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 TTS (Test)Drug
Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.
Neupro (Reference)Drug
Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference) | Experimental | For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h Receives: Drug: Rotigotine TTS (Test); Drug: Neupro (Reference) |
| Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test) | Active comparator | For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h Receives: Drug: Rotigotine TTS (Test); Drug: Neupro (Reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patch Adhesion
Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.
Measured: 24 hours in each Treatment Period
Secondary outcomes (4)
Number of patients with cold flow
Cold flow is defined as dark ring formed around the patch
Measured: 24 hours in each Treatment Period
Number of patients with patch movement/displacement
Measured: 24 hours in each Treatment Period
Number of patients with patch wrinkling
Measured: 24 hours in each Treatment Period
Number of patients with patch residue formation
Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin.
Measured: 24 hours in each Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start3 Dec 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Company Decision
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183634
- Sponsor's protocol ID
- 2019-06-TTS-10
- Status last verified
- Nov 2020
- First submitted
- 28 Nov 2019
- Last updated
- 9 Nov 2020
- 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 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
- ClinicalTrials.gov ID
- NCT04183634
- Acronym / sponsor ID
- 2019-06-TTS-10
- Conditions
- Parkinson Disease
- Keywords
- adhesiveness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 31 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 3 Dec 2019 (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 objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
Detailed description
The objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
The following evaluations will be assessed as "yes" or "no":
- Cold flow (dark ring formed around the patch)
- Patch movement/displacement
- Patch wrinkling
- Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.
AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).
As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference) | Experimental | Drug: Rotigotine TTS (Test), Drug: Neupro (Reference)For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h |
| Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test) | Active comparator | Drug: Rotigotine TTS (Test), Drug: Neupro (Reference)For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.
Key exclusion criteria (4 listed)
- Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
- History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
- History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
- History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.
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 TTS (Test)Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24. | Drug | Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test), Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference) |
| Neupro (Reference)Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h. | Drug | Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test), Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference) |
Primary outcome
Patch Adhesion
Time frame: 24 hours in each Treatment Period
Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.
4 secondary outcomes
Number of patients with cold flow
Time frame: 24 hours in each Treatment Period
Number of patients with patch movement/displacement
Time frame: 24 hours in each Treatment Period
Number of patients with patch wrinkling
Time frame: 24 hours in each Treatment Period
Number of patients with patch residue formation
Time frame: 24 hours in each Treatment Period
Results and safety
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- 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.
Sandoz study director
Sandoz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rotigotine TTS (Test) and Neupro (Reference) in people with Parkinson Disease, run by Sandoz at 1 site 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 1 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: stopped early, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Company Decision). Results are not available in the source record.
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?
Patch Adhesion (time frame: 24 hours in each Treatment Period). 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 9 Nov 2020.