Parkinson's DiseasePhase 1NCT01103011
Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
A Phase 1 study testing ND0611 in people with Parkinson's Disease, run by NeuroDerm Ltd. at 1 site in Israel.
Trial summary
The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- ND0611
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Oct 2010
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian males between 18 and 50 years (inclusive) of age
- Normal body weight
- 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.
- Haemoglobin level >12.5 mg /dl
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 15Show fewer
- Subjects with skin diseases or neoplasms
- Subjects with narrow-angle glaucoma
- Subjects with significant allergic response to other drugs.
- Subject with known atopic disorders
- Known allergy or hypersensitivity to adhesive tapes.
- 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 Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611
The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611
- Conditions
- Parkinson's Disease
- Being tested
- ND0611
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND0611Drug
Continuous delivery of ND0611
ND0611Drug
Solution of ND0611 delivered continuously
| Study group | Role | What they receive |
|---|---|---|
| ND0611 dose 1, ND0611 dose 2, placebo | Experimental | Not described Receives: Drug: ND0611 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability:
- Adverse event reporting
- Discontinuation of the treatment due to adverse event
Secondary outcomes (1)
Pharmacokinetics
Pharmacokinetic profile of plasma LD and CD:
- Primary endpoint: t½
- Secondary endpoints: through levels, Cmax, Tmax, AUC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroDerm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103011
- Sponsor's protocol ID
- ND0611/001
- Status last verified
- Apr 2010
- First submitted
- 12 Apr 2010
- Last updated
- 5 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611
- ClinicalTrials.gov ID
- NCT01103011
- Acronym / sponsor ID
- ND0611/001
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- NeuroDerm Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Apr 2010 (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 study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ND0611 dose 1, ND0611 dose 2, placebo | Experimental | Drug: ND0611 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Caucasian males between 18 and 50 years (inclusive) of age
- Normal body weight
- 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 (15 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 |
|---|---|---|
| ND0611Continuous delivery of ND0611 | Drug | ND0611 dose 1, ND0611 dose 2, placebo |
| ND0611Solution of ND0611 delivered continuously | Drug | ND0611 dose 1, ND0611 dose 2, placebo |
Primary outcome
Safety and tolerability
Safety and tolerability: * Adverse event reporting * Discontinuation of the treatment due to adverse event
1 secondary outcome
Pharmacokinetics
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 5 Oct 2010.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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 ND0611 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 6 inclusion and 15 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 5 Oct 2010. 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?
Safety and tolerability. 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 5 Oct 2010.