Parkinson's DiseasePhase 1NCT01725802
A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients
A Phase 1 study testing Levodopa/carbidopa solution for SC administration in people with Parkinson's Disease, run by NeuroDerm Ltd. at 1 site in Israel.
Trial summary
In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined. 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?
- Levodopa/carbidopa solution for SC administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Dec 2012to 26 Feb 2013
- Phase
- Phase 1
- 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
Main Inclusion Criteria:
- Men and women with idiopathic Parkinson's disease
- Subjects must experience motor fluctuations associated with LD/CD dosing
- Modified Hoehn and Yahr stage < 5
- Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
- Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
- Subjects must be age 30 or older.
- Subjects must be willing and able to give informed consent.
Main Exclusion Criteria:
- Subjects with a clinically significant or unstable medical or surgical condition
- Subjects with clinically significant psychiatric illness.
- Pre-menopausal women, not using birth control method.
- Subjects who have taken experimental medications within 60 days prior to baseline.
- Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.
Read the detailed description
Design: single center, double-blind, randomized, placebo-controlled, crossover study.
Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.
Population: Eight (8) PD subjects.
- Conditions
- Parkinson's Disease
- Being tested
- Levodopa/carbidopa solution for SC administration, Placebo
- 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/carbidopa solution for SC administrationDrug
Also called ND0612
PlaceboDrug
Also called Saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence A | Experimental | Period 1. ND0612; Period 2. Placebo Receives: Drug: Levodopa/carbidopa solution for SC administration; Drug: Placebo |
| Treatment sequence B | Experimental | Period 1. Placebo; Period 2. ND0612 Receives: Drug: Levodopa/carbidopa solution for SC administration; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and frequency of adverse events
- Incidence and frequency of adverse events
- Adverse events reporting related to the ND0612 application, local safety score
Measured: up to 8 weeks
Withdrawal rate
Withdrawal rates and discontinuations due to adverse events
Measured: 2 days
Secondary outcomes (1)
LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC
LD PK profile after oral LD dosing administered with or without ND0612:
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study start16 Dec 2012
- Primary completion26 Feb 2013
- Study completion26 Feb 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroDerm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725802
- Sponsor's protocol ID
- ND0612/002
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2012
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
- ClinicalTrials.gov ID
- NCT01725802
- Acronym / sponsor ID
- ND0612/002
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NeuroDerm Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2012 (actual)
- Primary completion
- 26 Feb 2013 (actual)
- Study completion
- 26 Feb 2013 (actual)
- First posted
- 14 Nov 2012 (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.
In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.
Detailed description
Design: single center, double-blind, randomized, placebo-controlled, crossover study.
Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.
Population: Eight (8) PD subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence A | Experimental | Drug: Levodopa/carbidopa solution for SC administration, Drug: PlaceboPeriod 1. ND0612; Period 2. Placebo |
| Treatment sequence B | Experimental | Drug: Levodopa/carbidopa solution for SC administration, Drug: PlaceboPeriod 1. Placebo; Period 2. ND0612 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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/carbidopa solution for SC administrationAlso: ND0612 | Drug | Treatment sequence A, Treatment sequence B |
| PlaceboAlso: Saline | Drug | Treatment sequence A, Treatment sequence B |
Primary outcome
Incidence and frequency of adverse events
Time frame: up to 8 weeks
1. Incidence and frequency of adverse events 2. Adverse events reporting related to the ND0612 application, local safety score
Withdrawal rate
Time frame: 2 days
Withdrawal rates and discontinuations due to adverse events
1 secondary outcome
LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC
Time frame: Up to 2 days
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 1 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levodopa/carbidopa solution for SC administration in people with Parkinson's Disease, run by NeuroDerm Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 May 2024. 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 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 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.
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?
Incidence and frequency of adverse events (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. 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 1 May 2024.