Parkinson's SyndromePhase 3NCT01950468
A Cross-Over, Multi-Center Trial to Evaluate the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes
A Phase 3 study testing NAV5001 and DaTscan in people with Parkinson's Syndrome, run by Navidea Biopharmaceuticals at 2 sites in United States.
Trial summary
This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Syndrome
- What is being tested?
- NAV5001 and DaTscan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2017to Mar 2018
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation
- Age ≥ 40 years
- Have had upper extremity tremor for < 3 years duration, regardless of presumed diagnosis or etiology
- Have a UPDRS part III score upon entry of ≤ 16
Who cannot join
- Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator
- Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)
- Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator
- Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator
- Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric Association, 1994])
- Positive urine drug screen for opiates, cocaine, or amphetamines at screening
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- Positive pregnancy test before imaging
- Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent
- Previous scan with any DAT imaging agent (e.g. [123I]NAV5001, Altropane, DaTscan, DOPASCAN)
- Any exposure to radiopharmaceuticals within 30 days before the date of informed consent
- Breast-feeding
- Inability to lie supine for 1 hour
- Any thyroid disease other than adequately treated hypothyroidism
- Known sensitivity or allergy to iodine or iodine containing products
- Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Compass Research
Orlando, Florida, 32806
Xenoscience, Inc.
Phoenix, Arizona, 85004
About this study
Official title: Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes
This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.
- Conditions
- Parkinson's Syndrome
- Being tested
- NAV5001, DaTscan
- Keywords
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAV5001Drug
A single intravenous dose of 8.0 ± 1.0 mCi
DaTscanDrug
A single intravenous dose of 3 to 5 mCi
| Study group | Role | What they receive |
|---|---|---|
| NAV5001 | Experimental | Not described Receives: Drug: NAV5001 |
| DaTscan | Active comparator | Not described Receives: Drug: DaTscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel
Measured: One Year
The incidence of positve [123I]NAV5001 SPECT brain scans
Measured: Baseline
The incidence of Parkinson' Syndrome based on the on-site neurologist assessment
Measured: Baseline
Secondary outcomes (3)
The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 6 months
Measured: 6 months
The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 1 year
Measured: 1 Year
Incidence of adverse events post baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startApr 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: The entire drug development program for this molecule was sold to another company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's SyndromeStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navidea Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cornelia Reininger, M.D. Ph.D., Study director, Navidea Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950468
- Sponsor's protocol ID
- NAV5-02
- Status last verified
- Sep 2017
- First submitted
- 23 Sep 2013
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes
- ClinicalTrials.gov ID
- NCT01950468
- Acronym / sponsor ID
- NAV5-02
- Conditions
- Parkinson's Syndrome
- Keywords
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The entire drug development program for this molecule was sold to another company.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Navidea BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 25 Sep 2013 (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.
This is a phase 3, open-label, multiple-center, randomized cross-over study to assess the safety and efficacy of [123I]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAV5001 | Experimental | Drug: NAV5001 |
| DaTscan | Active comparator | Drug: DaTscan |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation
- Age ≥ 40 years
- Have had upper extremity tremor for < 3 years duration, regardless of presumed diagnosis or etiology
- Have a UPDRS part III score upon entry of ≤ 16
Key exclusion criteria (15 listed)
- Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator
- Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)
- Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator
- Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator
- Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR [American Psychiatric Association, 1994])
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 |
|---|---|---|
| NAV5001A single intravenous dose of 8.0 ± 1.0 mCi | Drug | NAV5001 |
| DaTscanA single intravenous dose of 3 to 5 mCi | Drug | DaTscan |
Primary outcome
The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel
Time frame: One Year
The incidence of positve [123I]NAV5001 SPECT brain scans
Time frame: Baseline
The incidence of Parkinson' Syndrome based on the on-site neurologist assessment
Time frame: Baseline
3 secondary outcomes
The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 6 months
Time frame: 6 months
The incidence of Parkinson' Syndrome based on the on-site neurologist assessment at 1 year
Time frame: 1 Year
Incidence of adverse events post baseline
Time frame: 1 year
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 13 Sep 2017.
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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.
Cornelia Reininger, M.D. Ph.D. study director
Navidea Biopharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NAV5001 and DaTscan in people with Parkinson's Syndrome, run by Navidea Biopharmaceuticals at 2 sites in United States.
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 4 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: withdrawn, as of the sponsor's last update on 13 Sep 2017. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The incidence of Parkinson' Syndrome based on the Movement Disorder Specialist Consensus Panel (time frame: One Year). 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 13 Sep 2017.