Upper Extremity TremorAIMNCT00596908
123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor
An observational study of Upper Extremity Tremor, run by Alseres Pharmaceuticals, Inc at 7 sites in United States.
Trial summary
This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Upper Extremity Tremor
- How many people
- 54 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2007to Mar 2009
- Phase
- Observational
- 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
Study population: Patients with tremor referred to a Movement Disorder Specialist for evaluation
Who may be able to join
- Subjects must provide written informed consent prior to the initiation of any study related procedures;
- Subjects ≥ 40 years of age;
- Subjects with upper extremity tremor for < 2 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 Principal Investigator;
- Any unexpected clinically significant abnormal laboratory or ECG results obtained at Visit 1 and as determined by the Principal Investigator;
- Any history of drug, narcotic, or alcohol abuse within 2 years prior to the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IVR {American Psychiatric Association, 1994 #2});
- Positive urine drug screen at Visit 1;
- Participation in an investigational drug or device clinical trial within 30 days prior to the date of informed consent;
- Previous participation in any 123I-ALTROPANE® trial;
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- Any exposure to radiopharmaceuticals within 30 days prior to the date of informed consent;
- Positive (+) pregnancy test at Visit 1 and/or Visit 2;
- Breast-feeding;
- Inability to lie supine for 1 hour;
- Any significant active thyroid disease;
- Known sensitivity or allergy to Iodine or Iodine containing products;
- A history of repeated head injury or sustained severe head injury in year prior to onset of tremor;
- A definitive diagnosis of encephalitis;
- Any uncontrolled hypertension or diabetes;
- Any history of cerebrovascular disease;
- Previous evaluation by a Movement Disorder Specialist (MDS);
- Treatment within the previous six (6) months prior to informed consent with bupropion, metoclopramide, cinnarizine, flunarizine, methylphenidate, reserpine, modafinil, alpha methyldopa, amphetamine, or any anti-psychotic medication;
- Any treatment with anti-Parkinson's drugs or anti-tremor medications within three (3) months prior to the date of the subject signing the informed consent;
- Any new prescription or change in dose of medications for chronic conditions within four (4) weeks of Visit 2.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama
Birmingham, Alabama, 35233
UT Southwestern Medical Center
Dallas, Texas, 75390
University of Florida
Gainesville, Florida, 32610
University of Texas
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM)
This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. 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
This is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 90 subjects, male or female, 40 years of age or older.
This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Up to ninety subjects with upper extremity tremor for less than 2 years duration will be enrolled. Of these, at least thirty Parkinsonian syndromes subjects and at least thirty non-Parkinsonian syndromes subjects as diagnosed by a MDS will be enrolled.
Subjects will participate in three study visits over the course of the study period. The screening visit will include an assessment of eligibility as well as the collection of the MDS diagnosis. The second visit, during which all subjects receive a single intravenous injection of 123I-ALTROPANE® followed by SPECT imaging, will include appropriate safety assessments before and after dosing. The third visit will include follow-up safety. The subjects' participation in the study will range between 30 and 40 days.
- Conditions
- Upper Extremity Tremor
- Keywords
- Essential Tremor, Parkinsonian Tremor, Parkinson Disease, Upper Extremity Tremor with duration of less than 2 years
- Medical subject headings
- Essential Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with Parkinsonian Tremor (PT) | |
| 2 | Subjects with non Parkinsonian Tremor (nPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain a reference set of 123-I ALTROPANE® SPECT images.
Measured: Image obtained at Visit 2
Secondary outcomes (1)
To demonstrate the safety of 123-I ALTROPANE® in subjects with tremor for less than 2 years.
Measured: Safety assessments conducted at Visit 2, Visit 3, and via telephone follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startDec 2007
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity TremorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alseres Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596908
- Sponsor's protocol ID
- ALSE-A-01
- Acronym
- AIM
- Status last verified
- May 2009
- First submitted
- 4 Jan 2008
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor (AIM)
- ClinicalTrials.gov ID
- NCT00596908
- Acronym / sponsor ID
- AIM / ALSE-A-01
- Conditions
- Upper Extremity Tremor
- Keywords
- Essential Tremor, Parkinsonian Tremor, Parkinson Disease, Upper Extremity Tremor with duration of less than 2 years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Alseres Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Jan 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 study is designed to obtain an imaging training set that will be used to evaluate images in future trials. 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
This is a prospective, multi-center, non-randomized, open-label, out patient clinical trial which will include up to 90 subjects, male or female, 40 years of age or older.
This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Up to ninety subjects with upper extremity tremor for less than 2 years duration will be enrolled. Of these, at least thirty Parkinsonian syndromes subjects and at least thirty non-Parkinsonian syndromes subjects as diagnosed by a MDS will be enrolled.
Subjects will participate in three study visits over the course of the study period. The screening visit will include an assessment of eligibility as well as the collection of the MDS diagnosis. The second visit, during which all subjects receive a single intravenous injection of 123I-ALTROPANE® followed by SPECT imaging, will include appropriate safety assessments before and after dosing. The third visit will include follow-up safety. The subjects' participation in the study will range between 30 and 40 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with Parkinsonian Tremor (PT) |
| 2 | – | –Subjects with non Parkinsonian Tremor (nPT) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tremor referred to a Movement Disorder Specialist for evaluation
Key inclusion criteria (3 listed)
- Subjects must provide written informed consent prior to the initiation of any study related procedures;
- Subjects ≥ 40 years of age;
- Subjects with upper extremity tremor for < 2 years duration.
Key exclusion criteria (20 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 Principal Investigator;
- Any unexpected clinically significant abnormal laboratory or ECG results obtained at Visit 1 and as determined by the Principal Investigator;
- Any history of drug, narcotic, or alcohol abuse within 2 years prior to the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IVR {American Psychiatric Association, 1994 #2});
- Positive urine drug screen at Visit 1;
- Participation in an investigational drug or device clinical trial within 30 days prior to the date of informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To obtain a reference set of 123-I ALTROPANE® SPECT images.
Time frame: Image obtained at Visit 2
1 secondary outcome
To demonstrate the safety of 123-I ALTROPANE® in subjects with tremor for less than 2 years.
Time frame: Safety assessments conducted at Visit 2, Visit 3, and via telephone follow up
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 May 2009.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Tremor, run by Alseres Pharmaceuticals, Inc at 7 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 3 inclusion and 20 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 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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?
To obtain a reference set of 123-I ALTROPANE® SPECT images. (time frame: Image obtained at Visit 2). 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 May 2009.