Parkinsonian SyndromesPhase 3POET-2NCT00724906
Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor
A Phase 3 study testing 123 I - ALTROPANE® in people with Parkinsonian Syndromes, run by Alseres Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This will be two separate but identical studies: ALSE-A-02a, ALSE-A02b. Each study is designed to evaluate the diagnostic accuracy and safety of a single dose of 123I-ALTROPANE® in subjects with upper extremity tremor for less than three years. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinsonian Syndromes
- What is being tested?
- 123 I - ALTROPANE®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must provide written informed consent prior to the initiation of any study related procedures;
- Age 40 to 80 years;
- Subjects must have had upper extremity tremor for < 3 years duration.
Who cannot join
- Any clinically significant acute or unstable physical or psychological illness based on medical history or physical examination at Visit 1, as determined by the PI;
- Any unexpected clinically significant abnormal laboratory or electrocardiogram (ECG) results obtained at Visit 1 and as determined by the PI;
- Any history or 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-IVR, American Psychiatric Association, 1994;
- Positive drug screen for opiates, cocaine or amphetamines at Visit 1;
- Positive pregnancy test at Visit 1 and/or Visit 3;
- Participation in an investigational drug or device clinical trial within 30 days prior to the date of informed consent;
Show all 15Show fewer
- Previous participation in any 123I-ALTROPANE® trial;
- Any exposure to radiopharmaceuticals within 30 days prior to the date of informed consent;
- Breast-feeding;
- Inability to lie supine for 1 hour;
- Any thyroid disease other than treated hypothyroidism;
- Known sensitivity or allergy to iodine or iodine containing products;
- Treatment within the 4 weeks before the date of the informed consent with buproprion, methylphenidate or amphetamine;
- Any treatment with anti-Parkinson's drugs within 4 weeks before the date of informed consent.
- Subject eligibility based on exclusion criteria 1, 2, 3, 4, and 20 will be confirmed at Visit 3 prior to dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alseres Pharmaceuticals, Inc
Hopkinton, Massachusetts, 01748
Susan Flint, MS, RAC, CCRA, CCRP, 508-497-2360 ext. 242, sflint@talarisadvisors.com
About this study
Official title: Evaluation of the Diagnostic Accuracy and Safety of 123 I-ALTROPANE® as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes (POET-2)
This will be two separate but identical studies: ALSE-A-02a, ALSE-A02b. Each study is designed to evaluate the diagnostic accuracy and safety of a single dose of 123I-ALTROPANE® in subjects with upper extremity tremor for less than three years. Currently, no radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S. for use in diagnosing Parkinson disease and related Parkinsonian syndromes. The diagnosis of Parkinsonian syndromes in the U.S. is based on clinical criteria only. The goal is to demonstrate that 123I-ALTROPANE® paired with SPECT imaging permits a more accurate early diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.
Read the detailed description
Each study is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 240 subjects per study. Subjects will be male and female, age 40-80 years, with approximately 20 sites per study.
Subjects will participate in 5 study visits over the course of the study period. The screening visit will include an assessment of eligibility. The second visit will be the collection of the community neurologist's diagnostic assessment. The third visit, during which all subjects receive a single intravenous (IV) injection of 123I-ALTROPANE® and single photon emission computed tomography (SPECT) imaging, will include appropriate safety assessments before and after dosing. The fourth visit, to occur 24 to 72 hours after SPECT imaging, will include follow up safety assessments as well as the first Movement Disorder Specialist's (MDS) evaluation. The fifth visit, to occur 6 months (±7 days) after SPECT imaging, will include follow-up safety assessments as well as the MDS reevaluation and truth standard diagnosis. The subject's participation in the study will be up to 7 months.
- Conditions
- Parkinsonian Syndromes
- Being tested
- 123 I - ALTROPANE®
- Keywords
- Essential Tremor, Parkinsonian Tremor, Parkinson Disease, Upper Extremity Tremor with duration of less than 2 years, Diagnosis, Subjects, Upper, Extremity, Tremor, Less, Than 2 years
- Medical subject headings
- Parkinsonian Disorders, Essential Tremor, Parkinson Disease, Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
123 I - ALTROPANE®Drug
8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Parkinsonian Syndromes | Experimental | Subjects with Parkinsonian Syndromes Receives: Drug: 123 I - ALTROPANE® |
| Non-Parkinsonian Syndromes | Experimental | Subjects with Non-Parkinsonian Syndromes Receives: Drug: 123 I - ALTROPANE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic accuracy of a single dose of 123 I-ALTROPANE® as an imaging agent to aid in the diagnosis of Parkinsonian syndromes (PS) in subjects with upper extremity tremor for less than 2 years.
Measured: 7 months
Secondary outcomes (1)
To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsonian SyndromesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alseres Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724906
- Sponsor's protocol ID
- ALSE-A-02a, ALSE-A-02b
- Acronym
- POET-2
- Status last verified
- Feb 2010
- First submitted
- 28 Jul 2008
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Accuracy and Safety of 123 I-ALTROPANE® as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes (POET-2)
- ClinicalTrials.gov ID
- NCT00724906
- Acronym / sponsor ID
- POET-2 / ALSE-A-02a, ALSE-A-02b
- Conditions
- Parkinsonian Syndromes
- Keywords
- Essential Tremor, Parkinsonian Tremor, Parkinson Disease, Upper Extremity Tremor with duration of less than 2 years, Diagnosis, Subjects, Upper, Extremity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Alseres Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 30 Jul 2008 (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 will be two separate but identical studies: ALSE-A-02a, ALSE-A02b. Each study is designed to evaluate the diagnostic accuracy and safety of a single dose of 123I-ALTROPANE® in subjects with upper extremity tremor for less than three years. Currently, no radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S. for use in diagnosing Parkinson disease and related Parkinsonian syndromes. The diagnosis of Parkinsonian syndromes in the U.S. is based on clinical criteria only. The goal is to demonstrate that 123I-ALTROPANE® paired with SPECT imaging permits a more accurate early diagnosis of Parkinson disease than a clinical diagnosis by a general neurologist.
Detailed description
Each study is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 240 subjects per study. Subjects will be male and female, age 40-80 years, with approximately 20 sites per study.
Subjects will participate in 5 study visits over the course of the study period. The screening visit will include an assessment of eligibility. The second visit will be the collection of the community neurologist's diagnostic assessment. The third visit, during which all subjects receive a single intravenous (IV) injection of 123I-ALTROPANE® and single photon emission computed tomography (SPECT) imaging, will include appropriate safety assessments before and after dosing. The fourth visit, to occur 24 to 72 hours after SPECT imaging, will include follow up safety assessments as well as the first Movement Disorder Specialist's (MDS) evaluation. The fifth visit, to occur 6 months (±7 days) after SPECT imaging, will include follow-up safety assessments as well as the MDS reevaluation and truth standard diagnosis. The subject's participation in the study will be up to 7 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinsonian Syndromes | Experimental | Drug: 123 I - ALTROPANE®Subjects with Parkinsonian Syndromes |
| Non-Parkinsonian Syndromes | Experimental | Drug: 123 I - ALTROPANE®Subjects with Non-Parkinsonian Syndromes |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must provide written informed consent prior to the initiation of any study related procedures;
- Age 40 to 80 years;
- Subjects must have had upper extremity tremor for < 3 years duration.
Key exclusion criteria (15 listed)
- Any clinically significant acute or unstable physical or psychological illness based on medical history or physical examination at Visit 1, as determined by the PI;
- Any unexpected clinically significant abnormal laboratory or electrocardiogram (ECG) results obtained at Visit 1 and as determined by the PI;
- Any history or 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-IVR, American Psychiatric Association, 1994;
- Positive drug screen for opiates, cocaine or amphetamines at Visit 1;
- Positive pregnancy test at Visit 1 and/or Visit 3;
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 |
|---|---|---|
| 123 I - ALTROPANE®8.0 mCi (±1.0 mCi) will be administered intravenously to each subject. | Drug | Non-Parkinsonian Syndromes, Parkinsonian Syndromes |
Primary outcome
To evaluate the diagnostic accuracy of a single dose of 123 I-ALTROPANE® as an imaging agent to aid in the diagnosis of Parkinsonian syndromes (PS) in subjects with upper extremity tremor for less than 2 years.
Time frame: 7 months
1 secondary outcome
To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years.
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
Related trials for Parkinsonian Syndromes
RecruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingPhase 2
A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations
Parkinson Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
Recruiting
Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies
Photobiomodulation, Dementia With Lewy Bodies
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 123 I - ALTROPANE® in people with Parkinsonian Syndromes, run by Alseres Pharmaceuticals, Inc at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 3 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Flint, MS, RAC, CCRA, CCRP (508-497-2360 ext. 242, sflint@talarisadvisors.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic accuracy of a single dose of 123 I-ALTROPANE® as an imaging agent to aid in the diagnosis of Parkinsonian syndromes (PS) in subjects with upper extremity tremor for less than 2 years. (time frame: 7 months). 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 3 Feb 2010.