Parkinson's DiseasePhase 2NCT00558337
Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease
A Phase 2 study testing levodopa-carbidopa in people with Parkinson's Disease, run by Osmotica Pharmaceutical US LLC at 9 sites in Argentina.
Trial summary
Determine if a novel levodopa/carbidopa formulation results in a better clinical response on Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in terms of motor complications, onset of action and response duration. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- levodopa-carbidopa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 9 sitesArgentina
- Study dates
- Nov 2007to Dec 2008
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnostic of Parkinson's Disease, with a Hoehn and Yahr Staging within 2-4, and L-Dopa therapy complications
- at least 2years of L-Dopa therapy
- Patients with the ability to differentiate between "ON" and "OFF" periods
- Patients who have been receiving stable doses of L-Dopa between 600 and 1600 mg/day, for at least 2 months prior to the screening visit using a dosing regimen not higher that 5 times a day, and not expected in the investigator's opinion to need any dose modifications over the duration of the study
- Patients presenting a score of at least 2 in the UPDRS IVa, item 32 and/or a score of at least 2 in the UPDRS IVb, item 39, at screening and randomization visits based on clinical records for the first visit and daily diary cards at randomization time.
- Willing and able to understand and sign Informed Consent form
Who cannot join
- Patients with a diagnosis of any known secondary Parkinsonian syndrome, (vascular, toxin or drug-induced, metabolic or infectious, etc) or other neurodegenerative disorder with parkinsonism (Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, etc).
- Patients receiving other concomitant anti-Parkinsonian pharmacological therapies affecting L-dopa or dopamine metabolisom (COMT inhibitors or MAO inhibitors)
- Subjects who have undergone prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).
- Patient with a L-dopa dosage regimen greater than 5 times a day which is not able to be adapted to a q.i.d. regimen.
- Patients having received L-dopa / Decarboxylase inhibitors therapy for less than 2 years.
- Patients needing nightly doses of L-dopa / Decarboxylase inhibitors apart from the four daily doses.
Show all 15Show fewer
- Any medical condition or past medical history that, in the investigator's judgment, would increase the risk of exposure to L-dopa / Carbidopa or interfere with the evaluation of the study objectives.
- Patients with unstable or clinically significant known medical illness; such as cardiac, pulmonary, kidney, hepatic and/or gastrointestinal disease that would, in the investigator's judgment, interfere with the safe course of the study.
- Cognitive impaired patients, as determined by a score of lesser than 26 on the Mini-Mental Score Status Examination. (MMSE < 26).
- Alcohol or illegal drugs abuse.
- Pregnant or lactating patients.
- Hypersensitivity to any of the investigational drugs, based on known allergies to drugs of the same class.
- Patients having taken any research drugs over the last 30 days prior to the beginning of the study.
- Blood donation, or blood products, or participation to a clinical trial with serial blood withdrawals, within twelve weeks prior to the start of the trial, or intention to donate blood or blood products within three months following the study completion.
- Patients who have received some of the following medications with an anticipation of no more than 7 treatment-drug elimination half-lives of entry time: Dopamine D2 receptor antagonists , isoniazid, anti-epileptic drugs, IMAO A or B, pyridoxine, ferrous salts or methyldopa.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Argentina9 sites
Fundacion Alfredo Thomson
Buenos Aires
Hospital Posadas
Buenos Aires
Hospital Ramos Mejía
Buenos Aires
Hospital Sirio Libanés
Buenos Aires
Instituto Frenopático
Buenos Aires
nstituto INEBA
Buenos Aires
Policlínica Bancaria
Buenos Aires
Fundación Rosarina de Neuro-Rehabilitación
Rosario
Hospital San Bernardo
Salta
About this study
Official title: An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients
Determine if a novel levodopa/carbidopa formulation results in a better clinical response on Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in terms of motor complications, onset of action and response duration.
Read the detailed description
Primary objective is to demonstrate a better clinical response profile of novel levodopa/carbidopa formulation vs. the reference formulation of levodopa/carbidopa in patients with Parkinson's Disease as judged by motor performance and to describe pharmacokinetic profile for the novel formulation compared to the reference.
- Conditions
- Parkinson's Disease
- Being tested
- levodopa-carbidopa
- Keywords
- Treatment of Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa-carbidopaDrug
novel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: levodopa-carbidopa |
| B | Active comparator | Not described Receives: Drug: levodopa-carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of a novel levodopa/carbidopa formulation providing a better clinical profile than reference levodopa/carbidopa formulation using Unified Parkinson's Disease Rating Scale (UPDRS III) and patient's diary cards
Measured: every half hour for the first 8 hours after dosing
Secondary outcomes (1)
Other measurements to be used for demonstrating clinical profile is UPDRS II and IV, Clinical Global Impression Scale (CGI)/Patient's Global Improvement Scale (PGI), and the Abnormal Involuntary Movement Scale (AIMS)
Measured: over the course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmotica Pharmaceutical US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gustavo Fischbein, M.D., Study director, Osmotica Pharmaceutical Argentina S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558337
- Sponsor's protocol ID
- OS353-CTP 01
- Status last verified
- Jan 2009
- First submitted
- 12 Nov 2007
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT00558337
- Acronym / sponsor ID
- OS353-CTP 01
- Conditions
- Parkinson's Disease
- Keywords
- Treatment of Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Osmotica Pharmaceutical US LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Nov 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.
Determine if a novel levodopa/carbidopa formulation results in a better clinical response on Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in terms of motor complications, onset of action and response duration.
Detailed description
Primary objective is to demonstrate a better clinical response profile of novel levodopa/carbidopa formulation vs. the reference formulation of levodopa/carbidopa in patients with Parkinson's Disease as judged by motor performance and to describe pharmacokinetic profile for the novel formulation compared to the reference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: levodopa-carbidopa |
| B | Active comparator | Drug: levodopa-carbidopa |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnostic of Parkinson's Disease, with a Hoehn and Yahr Staging within 2-4, and L-Dopa therapy complications
- at least 2years of L-Dopa therapy
- Patients with the ability to differentiate between "ON" and "OFF" periods
- Patients who have been receiving stable doses of L-Dopa between 600 and 1600 mg/day, for at least 2 months prior to the screening visit using a dosing regimen not higher that 5 times a day, and not expected in the investigator's opinion to need any dose modifications over the duration of the study
- Patients presenting a score of at least 2 in the UPDRS IVa, item 32 and/or a score of at least 2 in the UPDRS IVb, item 39, at screening and randomization visits based on clinical records for the first visit and daily diary cards at randomization time.
Key exclusion criteria (15 listed)
- Patients with a diagnosis of any known secondary Parkinsonian syndrome, (vascular, toxin or drug-induced, metabolic or infectious, etc) or other neurodegenerative disorder with parkinsonism (Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, etc).
- Patients receiving other concomitant anti-Parkinsonian pharmacological therapies affecting L-dopa or dopamine metabolisom (COMT inhibitors or MAO inhibitors)
- Subjects who have undergone prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).
- Patient with a L-dopa dosage regimen greater than 5 times a day which is not able to be adapted to a q.i.d. regimen.
- Patients having received L-dopa / Decarboxylase inhibitors therapy for less than 2 years.
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 |
|---|---|---|
| levodopa-carbidopanovel levodopa/carbidopa formulation or a reference levodopa/carbidopa formulation | Drug | A, B |
Primary outcome
Evidence of a novel levodopa/carbidopa formulation providing a better clinical profile than reference levodopa/carbidopa formulation using Unified Parkinson's Disease Rating Scale (UPDRS III) and patient's diary cards
Time frame: every half hour for the first 8 hours after dosing
1 secondary outcome
Other measurements to be used for demonstrating clinical profile is UPDRS II and IV, Clinical Global Impression Scale (CGI)/Patient's Global Improvement Scale (PGI), and the Abnormal Involuntary Movement Scale (AIMS)
Time frame: over the course of the study
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 14 Jan 2009.
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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.
Gustavo Fischbein, M.D. study director
Osmotica Pharmaceutical Argentina S.A.
9 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 levodopa-carbidopa in people with Parkinson's Disease, run by Osmotica Pharmaceutical US LLC at 9 sites in Argentina.
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 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 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Argentina. 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?
Evidence of a novel levodopa/carbidopa formulation providing a better clinical profile than reference levodopa/carbidopa formulation using Unified Parkinson's Disease Rating Scale (UPDRS III) and patient's diary cards (time frame: every half hour for the first 8 hours after dosing). 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 14 Jan 2009.