Parkinson's DiseasePhase 1NCT02096601
A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients
A Phase 1 study testing LD/CD SC solution and Entacapone in people with Parkinson's Disease, run by NeuroDerm Ltd. at 2 sites in Israel.
Trial summary
An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase [COMT] inhibitor) in PD subjects with well-defined morning "OFF"… 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?
- LD/CD SC solution and Entacapone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesIsrael
- Study dates
- 11 Aug 2014to 15 Mar 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female PD patients of any race aged 30 to 80 years
- PD diagnosis consistent with the UK PD Society Brain Bank criteria.
- Stable doses of anti PD drugs for at least 30 days
- PD patients with well-defined morning "OFF" and a good response to LD
- MMSE score > 26
- No clinically significant medical, psychiatric or laboratory abnormalities
Who cannot join
- Atypical or secondary Parkinsonism.
- Acute psychosis or hallucinations.
- Subjects treated with neuroleptics
- History of melanoma or significant skin disorders.
- Prior neurosurgical procedure for PD.
- Patients with a history of drug abuse or alcoholism
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- Clinically significant ECG abnormalities.
- Renal or liver dysfunction
- Subjects who have participated in another clinical study within 30 days
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Center
Jerusalem
Tel Aviv Medical Center
Tel Aviv
About this study
Official title: A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD
An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase [COMT] inhibitor) in PD subjects with well-defined morning "OFF" and a good response to LD. Exploratory efficacy parameters were collected (early evidence of effectiveness as part of Phase 1).
Read the detailed description
PD subjects were randomized in Low or High LD dose study group in 1:1 ratio. Each patient received singe doses ND0612 over 3 days: Day 1. LD/CD 60/7.5 mg/mL, Day 2. LD/CD 60/14 mg, and Day 3. LD/CD 60/14 mg/mL with Entacapone.
- Conditions
- Parkinson's Disease
- Being tested
- LD/CD SC solution, Entacapone
- Keywords
- Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LD/CD SC solutionDrug
Also called ND0612
Levodopa/carbidopa SC solution
EntacaponeDrug
Entacapone 200 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| ND0612L Low LD Dose | Experimental | LD daily dose equals to 115 mg administered over 8 hours SC infusion:
* LD/CD 60/7.5 mg/mL on Study Day 3
* LD/CD 60/14 mg/mL on Study Day 4
* LD/CD 60/14 mg/mL and Entacapone 200 mg every 4 hours on Study Day 5 Receives: Drug: LD/CD SC solution; Drug: Entacapone |
| ND0612H High LD Dose | Experimental | LD daily dose equals to 307 mg administered over 8 hours SC infusion:
* LD/CD 60/7.5 mg/mL on Study Day 3
* LD/CD 60/14 mg/mL on Study Day 4
* LD/CD 60/14 mg/mL and Entacapone 200 mg every 4 hours on Study Day 5 Receives: Drug: LD/CD SC solution; Drug: Entacapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events frequency
Measured: Up to 6 weeks
LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.
Measured: Days 1, 2, 3 and 4
Tolerability: Number of patients who discontinued due to adverse events
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start11 Aug 2014
- Primary completion15 Mar 2015
- Study completion15 Mar 2015
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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroDerm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096601
- Sponsor's protocol ID
- ND0612/004
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2014
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD
- ClinicalTrials.gov ID
- NCT02096601
- Acronym / sponsor ID
- ND0612/004
- Conditions
- Parkinson's Disease
- Keywords
- Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NeuroDerm Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 11 Aug 2014 (actual)
- Primary completion
- 15 Mar 2015 (actual)
- Study completion
- 15 Mar 2015 (actual)
- First posted
- 26 Mar 2014 (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 open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase [COMT] inhibitor) in PD subjects with well-defined morning "OFF" and a good response to LD. Exploratory efficacy parameters were collected (early evidence of effectiveness as part of Phase 1).
Detailed description
PD subjects were randomized in Low or High LD dose study group in 1:1 ratio. Each patient received singe doses ND0612 over 3 days: Day 1. LD/CD 60/7.5 mg/mL, Day 2. LD/CD 60/14 mg, and Day 3. LD/CD 60/14 mg/mL with Entacapone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ND0612L Low LD Dose | Experimental | Drug: LD/CD SC solution, Drug: EntacaponeLD daily dose equals to 115 mg administered over 8 hours SC infusion: * LD/CD 60/7.5 mg/mL on Study Day 3 * LD/CD 60/14 mg/mL on Study Day 4 * LD/CD 60/14 mg/mL and Entacapone 200 mg every 4 hours on Study Day 5 |
| ND0612H High LD Dose | Experimental | Drug: LD/CD SC solution, Drug: EntacaponeLD daily dose equals to 307 mg administered over 8 hours SC infusion: * LD/CD 60/7.5 mg/mL on Study Day 3 * LD/CD 60/14 mg/mL on Study Day 4 * LD/CD 60/14 mg/mL and Entacapone 200 mg every 4 hours on Study Day 5 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female PD patients of any race aged 30 to 80 years
- PD diagnosis consistent with the UK PD Society Brain Bank criteria.
- Stable doses of anti PD drugs for at least 30 days
- PD patients with well-defined morning "OFF" and a good response to LD
- MMSE score > 26
Key exclusion criteria (9 listed)
- Atypical or secondary Parkinsonism.
- Acute psychosis or hallucinations.
- Subjects treated with neuroleptics
- History of melanoma or significant skin disorders.
- Prior neurosurgical procedure for PD.
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 |
|---|---|---|
| LD/CD SC solutionAlso: ND0612Levodopa/carbidopa SC solution | Drug | ND0612H High LD Dose, ND0612L Low LD Dose |
| EntacaponeEntacapone 200 mg oral tablet | Drug | ND0612H High LD Dose, ND0612L Low LD Dose |
Primary outcome
Adverse events frequency
Time frame: Up to 6 weeks
LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.
Time frame: Days 1, 2, 3 and 4
Tolerability: Number of patients who discontinued due to adverse events
Time frame: Up to 6 weeks
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 29 Apr 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LD/CD SC solution and Entacapone in people with Parkinson's Disease, run by NeuroDerm Ltd. at 2 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 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Adverse events frequency (time frame: Up to 6 weeks). The study lists 3 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 29 Apr 2024.