Parkinson's DiseasePhase 2NCT00947037
Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
A Phase 2 study testing AP-CD/LD in people with Parkinson's Disease, run by Intec Pharma Ltd. at 5 sites in Israel.
Trial summary
An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD) Read more about this study
- Who is it for?
- Ages 30 to 95 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- AP-CD/LD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesIsrael
- Study dates
- Aug 2012to Aug 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 30 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject satisfactorily completed study IN 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study
- Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2 hours OFF a day at the discretion of the PI (does not include early morning akinesia or nocturnal akinesia)
- Subject that has been treated for at least 3 months prior to the study with 500-1000 mg Levodopa + DDCI, in 4 or more divided doses per day
- Hoehn and Yahr stages I-III
- Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study
- Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study.
Who cannot join
- Subject has undergone Deep brain stimulation (DBS) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem)
- Subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation
- Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Rambam Medical Center
Haifa
Wolfson Medical Center
Holon
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
TASMC
Tel Aviv
About this study
Official title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects
An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)
- Conditions
- Parkinson's Disease
- Being tested
- AP-CD/LD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-CD/LDDrug
| Study group | Role | What they receive |
|---|---|---|
| Extension | Experimental | Open label extension, 1 arm Receives: Drug: AP-CD/LD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS)
Secondary outcomes (3)
Quality of Life questionnaires
Daytime sleepiness
Efficacy measures of motor symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startAug 2012
- Primary completionAug 2012
Why it stopped: The sponsor decided to postpone the performance of this study to after phase 3
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intec Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947037
- Sponsor's protocol ID
- IN 12 005
- Status last verified
- Sep 2012
- First submitted
- 24 Jul 2009
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects
- ClinicalTrials.gov ID
- NCT00947037
- Acronym / sponsor ID
- IN 12 005
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor decided to postpone the performance of this study to after phase 3
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Intec Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- First posted
- 27 Jul 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.
An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extension | Experimental | Drug: AP-CD/LDOpen label extension, 1 arm |
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject satisfactorily completed study IN 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study
- Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2 hours OFF a day at the discretion of the PI (does not include early morning akinesia or nocturnal akinesia)
- Subject that has been treated for at least 3 months prior to the study with 500-1000 mg Levodopa + DDCI, in 4 or more divided doses per day
- Hoehn and Yahr stages I-III
- Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study
Key exclusion criteria (3 listed)
- Subject has undergone Deep brain stimulation (DBS) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem)
- Subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation
- Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation
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 |
|---|---|---|
| AP-CD/LD | Drug | Extension |
Primary outcome
To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS)
3 secondary outcomes
Quality of Life questionnaires
Daytime sleepiness
Efficacy measures of motor symptoms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 AP-CD/LD in people with Parkinson's Disease, run by Intec Pharma Ltd. at 5 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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was withdrawn before enrolling participants, so there are no results.
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 assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS). 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 24 Nov 2015.