Parkinson's DiseasePhase 1NCT02448914
A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients
A Phase 1 study testing TRIGEL and Duodopa in people with Parkinson's Disease, run by LobSor Pharmaceuticals AB at 1 site in Sweden.
Trial summary
This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- TRIGEL and Duodopa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- May 2015to Jul 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent and judged by the Investigator to have decision-making capacity
- Advanced levodopa-responsive idiopathic PD currently treated with Duodopa infusion since minimum 30 days
- 30 years of age or older
- BMI between 17.0 and 31.0 kg/m2, both inclusive
- Agreed to use adequate contraceptive measures:
- Female patients who have been post-menopausal for more than one year or female patients of childbearing potential using a highly efficient method of contraception during the study (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner]). Oral contraceptives in combination with other contraceptives are accepted.
- Male patients being vasectomised or agreeing to use condoms during the study and having a partner who is using a highly efficient method of contraception as described above.
Who cannot join
- Hypersensitivity or allergy to the investigational medicinal product (IMP) or to chemically related products
- Contraindications for the use of levodopa or carbidopa or entacapone
- Needing a daily total dose of Duodopa during study participation exceeding 125 mL
- Increased fluctuation in clinical PD symptoms within 7 days prior to Screening
- Administration of an investigational drug within 3 months prior to Screening and/or current participation in another clinical study involving a pharmaceutical or a medical device class III
- Use of any forbidden medication as specified in Section 9.6 of the protocol
Show all 12Show fewer
- Known hepatitis B, hepatitis C or HIV infection
- Donation of blood or plasma or major blood loss (≥500 mL) within 3 months prior to Screening
- Positive urine drug test (amphetamine, benzodiazepines, tetrahydrocannabinol, cocaine or opiates) at Screening
- Known alcohol abuse
- Unwilling to meet the requirements of the protocol
- Other medical or social reasons for exclusion at the discretion of the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease
This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.
Read the detailed description
Intestinal infusion of Duodopa (levodopa and carbidopa) provides faster absorption, comparable levodopa bioavailability and significantly reduced intra-patient variability in levodopa concentrations relative to oral administration. TRIGEL also contains a third ingredient, entacapone. In tablet form, entacapone is shown to improve the bioavailability of levodopa and might extend the half-life of levodopa, avoiding deep troughs in levodopa plasma levels, and providing more continuous delivery of levodopa to the brain.
The intention with the study is to confirm that TRIGEL administration increases the area under the curve (AUC) for levodopa by combining levodopa, carbidopa, and entacapone and thereby lower the daily levodopa dose needed. It is expected that TRIGEL administration will result in a similar intra-patient variability in plasma levodopa concentrations as Duodopa during continuous administration.
- Conditions
- Parkinson's Disease
- Being tested
- TRIGEL, Duodopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIGELDrug
Also called Lecigon
All patients will receive TRIGEL. Treatment order is determined by randomization.
DuodopaDrug
Also called Duopa
All patients will receive Duodopa. Treatment order is determined by randomization.
| Study group | Role | What they receive |
|---|---|---|
| TRIGEL first, then Duodopa | Experimental | First Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
Both TRIGEL and Duodopa treatment consists of 3 individually adjusted and pre-defined doses: a morning dose, a continuous 14 h infusion, and extra bolus doses (if required).
All TRIGEL doses correspond to 80% of the pre-study individually optimised doses of Duodopa. All Duodopa doses correspond to 100% of the pre-study individually optimized doses of Duodopa.
Administration is done through duodenal or upper jejunal infusion via the patient's permanently inserted gastrojejunostomy tube by means of an ambulatory infusion pump. Receives: Drug: TRIGEL; Drug: Duodopa |
| Duodopa first, then TRIGEL | Experimental | First Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).
Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).
Both TRIGEL and Duodopa treatment consists of 3 individually adjusted and pre-defined doses: a morning dose, a continuous 14 h infusion, and extra bolus doses (if required).
All TRIGEL doses correspond to 80% of the pre-study individually optimised doses of Duodopa. All Duodopa doses correspond to 100% of the pre-study individually optimized doses of Duodopa.
Administration is done through duodenal or upper jejunal infusion via the patient's permanently inserted gastrojejunostomy tube by means of an ambulatory infusion pump. Receives: Drug: TRIGEL; Drug: Duodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa
Measured: During 14 h infusion on 2 consecutive days
Secondary outcomes (4)
Intra-individual Coefficient of Variation (3-14h) for Levodopa
The individual patient's coefficient of variation (CV) of levodopa plasma concentration during administration of TRIGEL and Duodopa respectively between 3 and 14 h after start of study drug. CV=100*sqrt (exp (SDlog*SDlog)-1) were SDlog denotes the standard deviation computed on logged plasma concentrations.
Measured: During 3-14h infusion on 2 consecutive days
Dose Adjusted AUC (0-14h) for Carbidopa
Measured: During 14 h infusion on 2 consecutive days
Number of Adverse Events
Measured: Patients will be followed for the duration of the hospital stay, an expected average of 3 days
Dose Adjusted AUC (0-14h) for 3-O-Methyldopa
Measured: During 14 h infusion on 2 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- LobSor Pharmaceuticals AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Responsible party
- Sponsor
- Investigators
- Dag Nyholm, Assoc. Prof., Principal investigator, Department of Neuroscience, Neurology, Uppsala University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448914
- Sponsor's protocol ID
- LSM-003
- Other IDs
- 2014-004891-46, 2014
- Status last verified
- Apr 2016
- First submitted
- 12 May 2015
- Last updated
- 23 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease
- ClinicalTrials.gov ID
- NCT02448914
- Acronym / sponsor ID
- LSM-003
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- LobSor Pharmaceuticals ABIndustry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Posted 23 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.
Detailed description
Intestinal infusion of Duodopa (levodopa and carbidopa) provides faster absorption, comparable levodopa bioavailability and significantly reduced intra-patient variability in levodopa concentrations relative to oral administration. TRIGEL also contains a third ingredient, entacapone. In tablet form, entacapone is shown to improve the bioavailability of levodopa and might extend the half-life of levodopa, avoiding deep troughs in levodopa plasma levels, and providing more continuous delivery of levodopa to the brain.
The intention with the study is to confirm that TRIGEL administration increases the area under the curve (AUC) for levodopa by combining levodopa, carbidopa, and entacapone and thereby lower the daily levodopa dose needed. It is expected that TRIGEL administration will result in a similar intra-patient variability in plasma levodopa concentrations as Duodopa during continuous administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRIGEL first, then Duodopa | Experimental | Drug: TRIGEL, Drug: DuodopaFirst Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate). Both TRIGEL and Duodopa treatment consists of 3 individually adjusted and pre-defined doses: a morning dose, a continuous 14 h infusion, and extra bolus doses (if required). All TRIGEL doses correspond to 80% of the pre-study individually optimised doses of Duodopa. All Duodopa doses correspond to 100% of the pre-study individually optimized doses of Duodopa. Administration is done through duodenal or upper jejunal infusion via the patient's permanently inserted gastrojejunostomy tube by means of an ambulatory infusion pump. |
| Duodopa first, then TRIGEL | Experimental | Drug: TRIGEL, Drug: DuodopaFirst Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate). Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Both TRIGEL and Duodopa treatment consists of 3 individually adjusted and pre-defined doses: a morning dose, a continuous 14 h infusion, and extra bolus doses (if required). All TRIGEL doses correspond to 80% of the pre-study individually optimised doses of Duodopa. All Duodopa doses correspond to 100% of the pre-study individually optimized doses of Duodopa. Administration is done through duodenal or upper jejunal infusion via the patient's permanently inserted gastrojejunostomy tube by means of an ambulatory infusion pump. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide informed consent and judged by the Investigator to have decision-making capacity
- Advanced levodopa-responsive idiopathic PD currently treated with Duodopa infusion since minimum 30 days
- 30 years of age or older
- BMI between 17.0 and 31.0 kg/m2, both inclusive
- Agreed to use adequate contraceptive measures:
Key exclusion criteria (12 listed)
- Hypersensitivity or allergy to the investigational medicinal product (IMP) or to chemically related products
- Contraindications for the use of levodopa or carbidopa or entacapone
- Needing a daily total dose of Duodopa during study participation exceeding 125 mL
- Increased fluctuation in clinical PD symptoms within 7 days prior to Screening
- Administration of an investigational drug within 3 months prior to Screening and/or current participation in another clinical study involving a pharmaceutical or a medical device class III
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 |
|---|---|---|
| TRIGELAlso: LecigonAll patients will receive TRIGEL. Treatment order is determined by randomization. | Drug | Duodopa first, then TRIGEL, TRIGEL first, then Duodopa |
| DuodopaAlso: DuopaAll patients will receive Duodopa. Treatment order is determined by randomization. | Drug | Duodopa first, then TRIGEL, TRIGEL first, then Duodopa |
Primary outcome
Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa
Time frame: During 14 h infusion on 2 consecutive days
4 secondary outcomes
Intra-individual Coefficient of Variation (3-14h) for Levodopa
Time frame: During 3-14h infusion on 2 consecutive days
Dose Adjusted AUC (0-14h) for Carbidopa
Time frame: During 14 h infusion on 2 consecutive days
Number of Adverse Events
Time frame: Patients will be followed for the duration of the hospital stay, an expected average of 3 days
Dose Adjusted AUC (0-14h) for 3-O-Methyldopa
Time frame: During 14 h infusion on 2 consecutive days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Dag Nyholm, Assoc. Prof. principal investigator
Department of Neuroscience, Neurology, Uppsala University Hospital, Sweden
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 TRIGEL and Duodopa in people with Parkinson's Disease, run by LobSor Pharmaceuticals AB at 1 site in Sweden.
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 7 inclusion and 12 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 23 May 2016. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 23 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa (time frame: During 14 h infusion on 2 consecutive days). 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 23 May 2016.