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Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor (POET-2)

Primary Purpose

Parkinsonian Syndromes

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

123 I - ALTROPANE®

About this trial

This is an interventional diagnostic trial for Parkinsonian Syndromes focused on measuring 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

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Sites / Locations

Alseres Pharmaceuticals, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Parkinsonian Syndromes

Non-Parkinsonian Syndromes

Arm Description

Subjects with Parkinsonian Syndromes

Subjects with Non-Parkinsonian Syndromes

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years.

Full Information

NCT ID

NCT00724906

First Posted

July 28, 2008

Last Updated

February 2, 2010

Sponsor

Alseres Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00724906

Brief Title

Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor

Acronym

POET-2

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

July 2011 (Anticipated)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Alseres Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinsonian Syndromes

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Parkinsonian Syndromes

Arm Type

Experimental

Arm Description

Subjects with Parkinsonian Syndromes

Arm Title

Non-Parkinsonian Syndromes

Arm Type

Experimental

Arm Description

Subjects with Non-Parkinsonian Syndromes

Intervention Type

Drug

Intervention Name(s)

123 I - ALTROPANE®

Intervention Description

8.0 mCi (±1.0 mCi) will be administered intravenously to each subject.

Primary Outcome Measure Information:

Title

Time Frame

7 months

Secondary Outcome Measure Information:

Title

To evaluate the safety of 123 I-ALTROPANE® in subjects with upper extremity tremor for less than 2 years.

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Susan Flint, MS, RAC, CCRA, CCRP

Phone

508-497-2360

Ext

242

sflint@talarisadvisors.com

Facility Information:

Facility Name

Alseres Pharmaceuticals, Inc

City

Hopkinton

State/Province

Massachusetts

ZIP/Postal Code

01748

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Susan Flint, MS, RAC, CCRA, CCRP

Phone

508-497-2360

Ext

242

sflint@talarisadvisors.com

12. IPD Sharing Statement

Learn more about this trial

Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor

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