Parkinson's DiseasePhase 2NCT00918177
An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease
A Phase 2 study testing AP09004 and Carbidopa/Levodopa, immediate release in people with Parkinson's Disease, run by Intec Pharma Ltd. at 7 sites in Israel.
Trial summary
The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- AP09004 and Carbidopa/Levodopa, immediate release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 7 sitesIsrael
- Study dates
- Jul 2009to Oct 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who have participated in another clinical trial within the last 30 days;
- Subjects with atypical Parkinsonism
- Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the physician responsible, contraindicates his/her participation.
- Subject with symptomatic gastroparesis with frequent vomiting (at least once a week).
- Subjects with a history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
- Prior gastro-intestinal surgery or current gastrointestinal conditions of clinical significance including ulcers, diarrhea, vomiting, bleeding, intestinal obstruction or inflammatory bowel disease, which, in the opinion of the physician responsible, contraindicates his/her participation.
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- History of drug or alcohol abuse.
- Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates his/her participation.
- Subjects suffering from psychological disorders that in the opinion of the physician responsible may interfere with full participation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites
Barzilai Medical Center, Department of Neurology, Movement disorders unit,
Ashkelon
Department of Neurology, Clalit University Medical Center
Beersheba
Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
Haifa
Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
Holon
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
TASMC
Tel Aviv
About this study
Official title: Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients
The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.
- Conditions
- Parkinson's Disease
- Being tested
- AP09004, Carbidopa/Levodopa, immediate release
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP09004Drug
Carbidopa/Levodopa, immediate releaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Early patients | Experimental | Not described Receives: Drug: AP09004; Drug: Carbidopa/Levodopa, immediate release |
| Moderate Patients | Experimental | Not described Receives: Drug: AP09004; Drug: Carbidopa/Levodopa, immediate release |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate blood level profiles and safety of the AP09004
Secondary outcomes (1)
Efficacy of AP09004 on motor scores in Parkinson's patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2012
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
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intec Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- T Gurevich, MD, Principal investigator, Tel-Aviv Sourasky Medical CenterR. Djaldetti, Prof. MD, Principal investigator, Rabin Medical CenterO. Cohen, MD, Principal investigator, Sheba Medical CenterIlana Schlesinger Schlesinger, MD, Principal investigator, Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's DiseaseRon Milo, M.D, Principal investigator, Barzilai Medical Center, Department of Neurology, Movement disorders unit, Ashkelon, IsraelPeter Farkas, M.D, Principal investigator, Department of Neurology, Clalit University Medical CenterMarieta Anca-Herschkovitsch, M.D, Principal investigator, Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918177
- Sponsor's protocol ID
- IN 09 004
- Status last verified
- Feb 2010
- First submitted
- 1 Jun 2009
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT00918177
- Acronym / sponsor ID
- IN 09 004
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Intec Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2012 (actual)
- First posted
- 11 Jun 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 purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early patients | Experimental | Drug: AP09004, Drug: Carbidopa/Levodopa, immediate release |
| Moderate Patients | Experimental | Drug: AP09004, Drug: Carbidopa/Levodopa, immediate release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Subjects who have participated in another clinical trial within the last 30 days;
- Subjects with atypical Parkinsonism
- Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the physician responsible, contraindicates his/her participation.
- Subject with symptomatic gastroparesis with frequent vomiting (at least once a week).
- Subjects with a history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
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 |
|---|---|---|
| AP09004 | Drug | Early patients, Moderate Patients |
| Carbidopa/Levodopa, immediate release | Drug | Early patients, Moderate Patients |
Primary outcome
To evaluate blood level profiles and safety of the AP09004
1 secondary outcome
Efficacy of AP09004 on motor scores in Parkinson's patients
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 28 May 2014.
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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.
T Gurevich, MD principal investigator
Tel-Aviv Sourasky Medical Center
R. Djaldetti, Prof. MD principal investigator
Rabin Medical Center
O. Cohen, MD principal investigator
Sheba Medical Center
7 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 AP09004 and Carbidopa/Levodopa, immediate release in people with Parkinson's Disease, run by Intec Pharma Ltd. at 7 sites in Israel.
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 0 inclusion and 9 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel. 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?
To evaluate blood level profiles and safety of the AP09004. 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 28 May 2014.