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

NCT00724906 | Unknown Phase 3

• 1 other identifier: ALSE-A-02a, ALSE-A-02b
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  7 months

Secondary Outcomes (1)

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

  7 months

Study Arms (2)

Parkinsonian Syndromes

EXPERIMENTAL

Subjects with Parkinsonian Syndromes

Drug: 123 I - ALTROPANE®

Non-Parkinsonian Syndromes

EXPERIMENTAL

Subjects with Non-Parkinsonian Syndromes

Drug: 123 I - ALTROPANE®

Interventions

123 I - ALTROPANE® DRUG

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

Non-Parkinsonian Syndromes; Parkinsonian Syndromes

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alseres Pharmaceuticals, Inc: lead

Study Sites (1)

Alseres Pharmaceuticals, Inc

Hopkinton, Massachusetts, 01748, United States

Location

MeSH Terms

Conditions

Parkinsonian Disorders; Essential Tremor; Parkinson Disease; Disease; Tremor

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Susan Flint, MS, RAC, CCRA, CCRP

CONTACT

508-497-2360; sflint@talarisadvisors.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

US (1)