Idiopathic Parkinson's DiseasePhase 1/2NCT01026428
A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics
A Phase 1/2 study testing Safinamide + Levodopa in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 2 sites in Italy.
Trial summary
The objective of this study is to investigate the effect of safinamide on levodopa blood levels, both after single and multiple dosing of safinamide . A further objective of the study is to assess the safety and tolerability of safinamide when given together with levodopa in the applied regimen. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Safinamide + Levodopa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2009to Jul 2010
- Phase
- Phase 1/2
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: male or female
- Age: 30 years
- Body Mass Index (BMI): 18 - 32 kg/m2
- Diagnosed with idiopathic Parkinson's disease, with Hoehn and Yahr (H\&Y) of I-III
- Levodopa-responsive patients treated with a stable dose of levodopa/carbidopa
- Electrocardiogram recording (12 leads) normal or with abnormalities which are not hazardous to the patient according to the opinion of the investigator.
- Negative beta-HCG test and not lactating (females). Women who are of childbearing potential must be using acceptable methods of contraception and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical research study. Accepted forms of contraception are: i.e. intrauterine device and a barrier method, combined oral contraceptives and a barrier method, or double-barrier method throughout the study. Female volunteers who are post -menopausal or surgically sterile may be enrolled
- Ability to maintain an accurate and complete dosing diary, with the help of a caregiver, recording doses of levodopa and study medication taken at home All parameters will be determined within three weeks prior to first dosing. Subjects must have given written informed consent before any study-related activities are carried out
Who cannot join
- To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Co-administration of other drugs causing dopamine release (e.g. reserpine) or affecting levodopa metabolism (e.g COMT inhibitors except AADC inhibitors) or any other medication clinically contraindicated with MAO B inhibitors or with levodopa/carbidopa Note: Use of Selective serotonin reuptake inhibitors [SSRI] and selective noradrenalin reuptake inhibitors [SNRI] will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial.
- Co-administration of other MAO inhibitors (e.g. selegiline, rasagiline)
- The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms
- Any indication of forms of Parkinsonism, other than idiopathic Parkinson's disease.
- Treatment with any agent known to inhibit or induce drug-metabolizing enzymes (e.g., barbiturates, St John's Wort etc.) within 4 weeks prior study treatment
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- Concomitant oral iron treatment
- History of hypersensitivity or contraindications to MAO-B inhibitors or levodopa
- Clinically relevant allergies (especially hypersensitivity toward any medicinal drugs)
- Significant hepatic impairment
- Significant renal impairment
- Diseases or surgeries of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility
- Diagnosis of Human Immunodeficiency Virus (HIV), or acute Hepatitis B or C
- Clinically relevant disease which in the investigator's opinion would exclude the subject from the study, such as significant cardiovascular and lung diseases, narrow-angle glaucoma or endocrinological diseases such as hyperthyroidism or pheochromocytoma
- A neoplastic disorder, which is either currently active or has been in remission for less than one year.
- Active psychiatric disease (e.g, schizophrenia, psychotic depression)
- History of melanoma or current cancer disease and undiagnosed, but melanoma suspicious skin lesion
- Signs for dementia which could interfere with the compliance to the study as judged by the investigator
- Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
- Consumption of important quantities of coffee or tea corresponding to more than 600 mg caffeine/day, or tobacco smoking (more than 10 cigarettes per day)
- Diet considerably deviating from normal nutritional patterns (e.g. vegan; diets with very high protein content [Atkins])
- Participation in another clinical study within 30 days prior to the planned first drug administration
- Alcohol and drug abuse (during the past three years)
- Transfusion of blood or plasma derivatives within 3 month prior to the planned first drug administration
- Blood donation within 90 days before the start of the clinical study
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease
The objective of this study is to investigate the effect of safinamide on levodopa blood levels, both after single and multiple dosing of safinamide . A further objective of the study is to assess the safety and tolerability of safinamide when given together with levodopa in the applied regimen.
For that purpose, all study participants will undergo intensive blood sampling for investigation of levodopa levels and various tolerability examinations, such as the measurement of vital signs (blood pressure, pulse, body temperature), recording of ECGs and questioning to find out how the study participants are feeling. Furthermore, blood samples will be drawn and urine tests will be performed repeatedly for safety purpose during the course of the study.
The results of this clinical trial may be used for the drug registration of safinamide in the future.
Read the detailed description
Treatments are given in a crossover design.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Safinamide + Levodopa, Placebo + Levodopa
- Keywords
- safinamide, levodopa, drug -drug interaction, pharmacokinetics, Patients diagnosed with idiopathic Parkinson's disease, levodopa-responsive, treated with a stable dose of levodopa/carbidopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safinamide + LevodopaDrug
Treatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
Placebo + LevodopaOther
Treatment B: Placebo matching 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
| Study group | Role | What they receive |
|---|---|---|
| Safinamide + Levodopa | Experimental | Not described Receives: Drug: Safinamide + Levodopa |
| Placebo + Levodopa | Placebo comparator | Not described Receives: Other: Placebo + Levodopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC and Cmax of Levodopa
Measured: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period.
Secondary outcomes (1)
tmax, CL, t1/2 of Levodopa
Measured: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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 1/2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonja Krösser, PhD, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026428
- Sponsor's protocol ID
- 28780
- Status last verified
- Jan 2012
- First submitted
- 1 Dec 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01026428
- Acronym / sponsor ID
- 28780
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- safinamide, levodopa, drug -drug interaction, pharmacokinetics, Patients diagnosed with idiopathic Parkinson's disease, levodopa-responsive, treated with a stable dose of levodopa/carbidopa
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 4 Dec 2009 (estimated)
- 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 investigate the effect of safinamide on levodopa blood levels, both after single and multiple dosing of safinamide . A further objective of the study is to assess the safety and tolerability of safinamide when given together with levodopa in the applied regimen.
For that purpose, all study participants will undergo intensive blood sampling for investigation of levodopa levels and various tolerability examinations, such as the measurement of vital signs (blood pressure, pulse, body temperature), recording of ECGs and questioning to find out how the study participants are feeling. Furthermore, blood samples will be drawn and urine tests will be performed repeatedly for safety purpose during the course of the study.
The results of this clinical trial may be used for the drug registration of safinamide in the future.
Detailed description
Treatments are given in a crossover design.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safinamide + Levodopa | Experimental | Drug: Safinamide + Levodopa |
| Placebo + Levodopa | Placebo comparator | Other: Placebo + Levodopa |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Gender: male or female
- Age: 30 years
- Body Mass Index (BMI): 18 - 32 kg/m2
- Diagnosed with idiopathic Parkinson's disease, with Hoehn and Yahr (H\&Y) of I-III
- Levodopa-responsive patients treated with a stable dose of levodopa/carbidopa
Key exclusion criteria (26 listed)
- To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Co-administration of other drugs causing dopamine release (e.g. reserpine) or affecting levodopa metabolism (e.g COMT inhibitors except AADC inhibitors) or any other medication clinically contraindicated with MAO B inhibitors or with levodopa/carbidopa Note: Use of Selective serotonin reuptake inhibitors [SSRI] and selective noradrenalin reuptake inhibitors [SNRI] will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial.
- Co-administration of other MAO inhibitors (e.g. selegiline, rasagiline)
- The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms
- Any indication of forms of Parkinsonism, other than idiopathic Parkinson's disease.
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 |
|---|---|---|
| Safinamide + LevodopaTreatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®). | Drug | Safinamide + Levodopa |
| Placebo + LevodopaTreatment B: Placebo matching 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®). | Other | Placebo + Levodopa |
Primary outcome
AUC and Cmax of Levodopa
Time frame: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period.
1 secondary outcome
tmax, CL, t1/2 of Levodopa
Time frame: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period.
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 29 Mar 2013.
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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.
Sonja Krösser, PhD study director
Merck KGaA, Darmstadt, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Safinamide + Levodopa in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 2 sites in Italy.
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 8 inclusion and 26 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
AUC and Cmax of Levodopa (time frame: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each 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 29 Mar 2013.