• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: 123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. (AIM)
Sponsor: Alseres Pharmaceuticals, Inc.
Clinicaltrials.gov ID: NCT00596908
Study ID: ALSE-A-01

Summary

ALTROPANE is a diagnostic molecular imaging agent being developed to aid in the differentiation of parkinsonian syndromes  Parkinsonian SyndromesA group of diseases characterized by symptoms (e.g. tremor, rigidity or stiffness, slow movements and difficulty maintaining balance) common in Parkinson's disease. from non-parkinsonian tremor. This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Up to ninety people with upper extremity tremor for less than 2 years duration will be enrolled. Of these, at least thirty Parkinsonian syndromes participants and at least thirty non-Parkinsonian syndromes participants, as diagnosed by a Movement Disorder Specialist, will be enrolled. Participants will partake in three study visits over the course of the study period. The screening  ScreeningPeriod of selection of clinical trial participants based on ELIGIBILITY CRITERIA. visit will include an assessment of eligibility as well as the collection of the diagnosis. The second visit, during which all participants receive a single 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. Participation in the study will range between 30 and 40 days.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than six months
• Three visits over the course of 30-40 days.

Eligibility

• Minimum Age: 40
• Gender(s) Accepted: Either

Inclusion Criteria

• Must provide written informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. prior to the initiation of any study related procedures.
• Upper extremity tremor for less than 2 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 Principal Investigator.  Principal InvestigatorPerson responsible for management of a clinical trial, ensuring it is conducted in compliance with the study protocol.
• 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.
• Positive urine drug screen at Visit 1.
• Participation in an investigational drug  Investigational DrugDrug that is being tested in clinical trials prior to receiving FDA approval for use on the open market or as a treatment for a particular condition. or device clinical trial  Clinical Trial (Clinical Study)A scientific study involving human participants to determine the safety and efficacy of new therapies or new ways of using known treatments. 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 informed consent.
• Positive (+) pregnancy test at Visit 1 and/or Visit 2.
• Breast-feeding.
• Inability to lie on one's back 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 (high blood pressue) or diabetes.
• Any history of cerebrovascular disease (relating to the brain and its blood vessels).
• 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 informed consent.
• Any new prescription or change in dose of medications for chronic conditions within four (4) weeks of Visit 2.

Enrollment

Expected Enrollment: 90 (US)
Date Enrollment Began: Dec 01 2007
Last Updated Date: Feb 11 2008
Trial Post Date: Feb 11 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00596908?term=NCT00596908&rank=1

Primary Contacts and Locations

• Susan Flint, MS, RAC, CCRA, CCRP
  (alt: Beth Hriczo, below)
  sflint@alseres.com
  Phone: (781) 939-0799 x418
  

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