Parkinson's DiseasePhase 1NCT01486628
Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
A Phase 1 study testing ND0612 in people with Parkinson's Disease, run by NeuroDerm Ltd. at 1 site in Israel.
Trial summary
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers. Objectives are to determine: 1. the maximal tolerated dose of SC ND-0612 2. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ND0612
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Apr 2012to 13 Jun 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian males between 18 and 40 years (inclusive) of age
- Normal BMI (18.5-24.9)
- Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests
- Subjects must be able to adhere to the protocol requirements
- Subjects must provide written informed consent to participate in the study.
Who cannot join
- History of significant psychiatric disorder, neurological diseases or sleep disorders
- History of significant systemic diseases, by medical history or tests performed during screening examinations
- Clinically significant laboratory tests at screening
- History of drug or alcohol abuse.
- Allergy to levodopa, carbidopa or any inactive component of the test formulation.
- Subjects with dark skin
Show all 14Show fewer
- Subjects with skin diseases or neoplasms
- Subjects with narrow-angle glaucoma
- Subjects with significant allergic response to other drugs.
- Presence of clinically significant scars or other skin disorders in the area of placement of the pump.
- Use of any prescription or over-the-counter (OTC) medications
- Subjects who donated blood or received blood, in the last 3 months
- Participation in another clinical trial in the last 30 days
- Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers.
Objectives are to determine:
- the maximal tolerated dose of SC ND-0612
- the steady state plasma concentration of LD and CD following SC ND-0612 administration.
Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.
- Conditions
- Parkinson's Disease
- Being tested
- ND0612, 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.
ND0612Drug
levodopa and carbidopa solution for subcutaneous administration
PlaceboDrug
Saline solution for SC continuous administration
| Study group | Role | What they receive |
|---|---|---|
| levodopa and carbidopa | Placebo comparator | Not described Receives: Drug: ND0612 |
| Placebo | Placebo comparator | Saline solution for subcutaneous administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters:
- Incidence and frequency of local adverse events related to the ND0612 Sc administration.
- Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study start30 Apr 2012
- Primary completion22 Nov 2012
- Study completion13 Jun 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroDerm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoseph Caraco, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486628
- Sponsor's protocol ID
- ND0612/001 and 001b
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2011
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01486628
- Acronym / sponsor ID
- ND0612/001 and 001b
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NeuroDerm Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 22 Nov 2012 (actual)
- Study completion
- 13 Jun 2013 (actual)
- First posted
- 6 Dec 2011 (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.
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers.
Objectives are to determine:
- the maximal tolerated dose of SC ND-0612
- the steady state plasma concentration of LD and CD following SC ND-0612 administration.
Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levodopa and carbidopa | Placebo comparator | Drug: ND0612 |
| Placebo | Placebo comparator | Drug: PlaceboSaline solution for subcutaneous administration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Caucasian males between 18 and 40 years (inclusive) of age
- Normal BMI (18.5-24.9)
- Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests
- Subjects must be able to adhere to the protocol requirements
- Subjects must provide written informed consent to participate in the study.
Key exclusion criteria (14 listed)
- History of significant psychiatric disorder, neurological diseases or sleep disorders
- History of significant systemic diseases, by medical history or tests performed during screening examinations
- Clinically significant laboratory tests at screening
- History of drug or alcohol abuse.
- Allergy to levodopa, carbidopa or any inactive component of the test formulation.
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 |
|---|---|---|
| ND0612levodopa and carbidopa solution for subcutaneous administration | Drug | levodopa and carbidopa |
| PlaceboSaline solution for SC continuous administration | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: 2 weeks
The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters: * Incidence and frequency of local adverse events related to the ND0612 Sc administration. * Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded
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 18 Jan 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.
Yoseph Caraco, MD principal investigator
Hadassah Medical Organization
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 ND0612 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?
The sponsor lists 5 inclusion and 14 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 18 Jan 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability (time frame: 2 weeks). 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 18 Jan 2024.