Parkinson's DiseasePhase 1/2NCT00491998
PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets
A Phase 1/2 study testing V1512 and V1512 and Entacapone in people with Parkinson's Disease, run by Vernalis (R&D) Ltd at 1 site in Italy.
Trial summary
The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease 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?
- V1512 and V1512 and Entacapone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2006to Nov 2007
- 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
- Male or female, >30 years of age of any race;
- A Body Mass Index between 18.5 and 29.9 kg/m2 (inclusive);
- Clinical diagnosis according to the Brain Bank diagnostic criteria of idiopathic Parkinson's Disease (2 of 3 cardinal symptoms - bradykinesia, rigidity, tremor -must be present, with a positive response to L-dopa);
- Presence of fluctuations in motor performance with >2 hours inclusive of daytime OFF episodes (not applicable for cohort 1 patients);
- At least 1 hour delay to ON time with afternoon doses;
- Discontinued use of COMT inhibitors (cathecol-o-methyl transferase) for at least 2 weeks prior to study entry (not applicable for cohort 3 patients);
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- Stable doses of dopamine agonists or selegiline for at least 2 weeks before entry into the study;
- Stable comorbidity for 4 weeks;
- Female patients must be of non-childbearing potential (post-menopausal or physically incapable of childbearing);
- Willing and able to give informed consent according to national legal requirements prior to initiation of any study-related procedures
Who cannot join
- Clinically relevant abnormal vital sign values or safety laboratory data.
- Patients who smoke and are unable to refrain from smoking during the in-clinic period
- Diagnosis of atypical parkinsonism;
- A history and/or the presence of gastro-intestinal disorders (or surgery) that could interfere with absorption of the test medication;
- A history of intolerance or clinically relevant allergy to L-dopa and/or carbidopa taken in any formulation or combination;
- A history of intolerance or clinically relevant allergy to entacapone or any ingredients of Comtan (cohort 3 patients only)
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- Any other condition which, in the opinion of the Investigator, would interfere with optimal participation in the study e.g. inability to complete patient diary;
- Participation in any clinical study or receiving treatment with another investigational drug within 30 days or 5 half lives (whichever is longer) before the screening visit;
- Blood donation within 3 months before study participation;
- History of neuroleptic malignant syndrome (NMS) or NMS-like syndromes, or non-traumatic rhabdomyolysis;
- Patients taking non-selective MAO inhibitors;
- Patients with a history of, or clinical indication of, narrow angle glaucoma;
- Patients with a history of, or clinical indication of, malignant melanoma;
- Patients with a history of, or clinical indication of, depression or psychosis;
- Patients taking iron containing medications (ferrous sulphate, ferrous gluconate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets
The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease
Read the detailed description
The pharmacokinetics of V1512 effervescent tablet has been evaluated in healthy volunteers, however not fully in PD patients. This study aims to evaluate the PK profiles in PD patients of different dosing schedules of V1512 effervescent tablet compared to the profiles after standard L-dopa/carbidopa (Sinemet) over the course of the day. Two dosing schedules have been chosen to evaluate a possible relation between dosing interval and 'ON' time, with and without associated dyskinesia. Similar dosing schedules with the comparator Sinemet are commonly employed in the treatment of fluctuating PD patients. Patients assigned to cohort 3 will also take a dose of entacapone concomitantly with each dose of V1512 or Sinemet, thereby allowing the kinetics and dynamics of.V1512 and Sinemet to be compared in the presence of COMT inhibition.
Safety and tolerability of the dosing regimens in patients will also be assessed further in this double-blind study
- Conditions
- Parkinson's Disease
- Being tested
- V1512, V1512 and Entacapone
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V1512Drug
6 doses of IMP at 2-hourly intervals
V1512Drug
3-hourly dosing
V1512 and EntacaponeDrug
4 doses of IMP and Entacapone at 3-hourly intervals
| Study group | Role | What they receive |
|---|---|---|
| 2-hourly dosing | Experimental | 6 Doses of IMP at 2-hourly intervals Receives: Drug: V1512 |
| 3-hourly dosing | Experimental | 4 doses of IMP at 3-hourly intervals Receives: Drug: V1512 |
| 3-hourly dosing plus Entacapone | Active comparator | 4 doses of IMP plus Entacapone at 3-hourly intervals Receives: Drug: V1512 and Entacapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
to characterise the plasma concentrations of L-dopa after repeated doses of V1512 in fluctuating PD patients compared to standard L-dopa/carbidopa (Sinemet) over the course of the day
Measured: 4 weeks
Secondary outcomes (2)
correlate plasma concentrations with response to therapy;
Measured: 4 weeks
further characterise the safety and tolerability profile for each treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vernalis (R&D) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cita NeuroPharmaceuticals, Syneos Health
- Investigators
- Fabrizio Stocchi, MD, PhD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491998
- Sponsor's protocol ID
- V1512-2PD01
- Status last verified
- Jul 2011
- First submitted
- 26 Jun 2007
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Stocchi F, Vacca L, Grassini P, Pawsey S, Whale H, Marconi S, Torti M. L-Dopa Pharmacokinetic Profile with Effervescent Melevodopa/Carbidopa versus Standard-Release Levodopa/Carbidopa Tablets in Parkinson's Disease: A Randomised Study. Parkinsons Dis. 2015;2015:369465. doi: 10.1155/2015/369465. Epub 2015 Jun 10.
PubMed 26171276
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets
- ClinicalTrials.gov ID
- NCT00491998
- Acronym / sponsor ID
- V1512-2PD01
- Conditions
- Parkinson's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Vernalis (R&D) LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cita NeuroPharmaceuticals, Syneos Health
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Jun 2007 (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 purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease
Detailed description
The pharmacokinetics of V1512 effervescent tablet has been evaluated in healthy volunteers, however not fully in PD patients. This study aims to evaluate the PK profiles in PD patients of different dosing schedules of V1512 effervescent tablet compared to the profiles after standard L-dopa/carbidopa (Sinemet) over the course of the day. Two dosing schedules have been chosen to evaluate a possible relation between dosing interval and 'ON' time, with and without associated dyskinesia. Similar dosing schedules with the comparator Sinemet are commonly employed in the treatment of fluctuating PD patients. Patients assigned to cohort 3 will also take a dose of entacapone concomitantly with each dose of V1512 or Sinemet, thereby allowing the kinetics and dynamics of.V1512 and Sinemet to be compared in the presence of COMT inhibition.
Safety and tolerability of the dosing regimens in patients will also be assessed further in this double-blind study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2-hourly dosing | Experimental | Drug: V15126 Doses of IMP at 2-hourly intervals |
| 3-hourly dosing | Experimental | Drug: V15124 doses of IMP at 3-hourly intervals |
| 3-hourly dosing plus Entacapone | Active comparator | Drug: V1512 and Entacapone4 doses of IMP plus Entacapone at 3-hourly intervals |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, >30 years of age of any race;
- A Body Mass Index between 18.5 and 29.9 kg/m2 (inclusive);
- Clinical diagnosis according to the Brain Bank diagnostic criteria of idiopathic Parkinson's Disease (2 of 3 cardinal symptoms - bradykinesia, rigidity, tremor -must be present, with a positive response to L-dopa);
- Presence of fluctuations in motor performance with >2 hours inclusive of daytime OFF episodes (not applicable for cohort 1 patients);
- At least 1 hour delay to ON time with afternoon doses;
Key exclusion criteria (15 listed)
- Clinically relevant abnormal vital sign values or safety laboratory data.
- Patients who smoke and are unable to refrain from smoking during the in-clinic period
- Diagnosis of atypical parkinsonism;
- A history and/or the presence of gastro-intestinal disorders (or surgery) that could interfere with absorption of the test medication;
- A history of intolerance or clinically relevant allergy to L-dopa and/or carbidopa taken in any formulation or combination;
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 |
|---|---|---|
| V15126 doses of IMP at 2-hourly intervals | Drug | 2-hourly dosing |
| V15123-hourly dosing | Drug | 3-hourly dosing |
| V1512 and Entacapone4 doses of IMP and Entacapone at 3-hourly intervals | Drug | 3-hourly dosing plus Entacapone |
Primary outcome
to characterise the plasma concentrations of L-dopa after repeated doses of V1512 in fluctuating PD patients compared to standard L-dopa/carbidopa (Sinemet) over the course of the day
Time frame: 4 weeks
2 secondary outcomes
correlate plasma concentrations with response to therapy;
Time frame: 4 weeks
further characterise the safety and tolerability profile for each treatment
Time frame: 4 weeks
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 25 Jul 2011.
- Derived from this study: PubMed 26171276Stocchi F, Vacca L, Grassini P, Pawsey S, Whale H, Marconi S, Torti M. L-Dopa Pharmacokinetic Profile with Effervescent Melevodopa/Carbidopa versus Standard-Release Levodopa/Carbidopa Tablets in Parkinson's Disease: A Randomised Study. Parkinsons Dis. 2015;2015:369465. doi: 10.1155/2015/369465. Epub 2015 Jun 10.
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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.
Fabrizio Stocchi, MD, PhD principal investigator
IRCCS San Raffaele
1 site 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 V1512 and V1512 and Entacapone in people with Parkinson's Disease, run by Vernalis (R&D) Ltd at 1 site 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 10 inclusion and 15 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 25 Jul 2011. 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 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. 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?
to characterise the plasma concentrations of L-dopa after repeated doses of V1512 in fluctuating PD patients compared to standard L-dopa/carbidopa (Sinemet) over the course of the day (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00491998, which also lists 1 linked publication.
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 25 Jul 2011.