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Business Decision
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| Name | Class |
|---|---|
| Fortrea | INDUSTRY |
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Previous studies showed that a dose of 8 millicuries of Altropane was appropriate for imaging patients with suspected Parkinson's disease. This study determined if a lower dose (5 millicuries) would suffice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Altropane (123I) Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Altropane (123I) Injection | Drug | Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels [MBq]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers. |
| Measure | Description | Time Frame |
|---|---|---|
| Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers | Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers). | Day 1, up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization) | Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers evaluated their confidence in striatal visualization, rating it as high, medium, or low. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the high and medium/low groupings. Percentage of participants with confidence ratings for 5-mCi Altropane images are reported. |
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Inclusion Criteria:
For Part 2 (which was not conducted): a) the participant had a DaTscan image, obtained within 1 year (preferably within 6 months) before screening, that showed abnormal (unilateral or bilateral reduced) striatal uptake and b) the participant also had a confirmed clinical diagnosis of a dPS (such as Parkinson's disease, multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, etc.) made by a board-certified neurologist who was qualified by training and experience in the diagnosis of movement disorders, and c) the diagnosis was consistent with the DaTscan image.
The participant was male or female, ≥18 years of age, of any race and ethnicity.
The participant was able and willing to comply with study procedures and signed and dated informed consent was obtained.
If the participant was a woman of childbearing potential*, she must have used a highly effective method of contraception** from Screening until 30 days after the last administration of Altropane, and the results of a serum or urine human chorionic gonadotropin (hCG) pregnancy test, performed at Screening and on the day of Altropane administration (with the result known before Altropane administration), must have been negative.
* A woman of childbearing potential was defined as neither post-menopausal nor surgically sterile. Post-menopausal means having had no menses for at least 12 months without an alternative medical cause. Surgically sterile means having had a documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or any combination of these.
** A highly effective method of contraception was defined as one that had a failure rate of less than 1% per year when used consistently and correctly; such methods included combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation/occlusion; vasectomized partner (with medical confirmation of success); and abstinence from heterosexual intercourse involving a woman of childbearing potential.
If the participant was a male*** with a sexual partner who was a woman of childbearing potential*, he and his partner must have used adequate contraception** from Screening until 30 days after the last administration of Altropane.
(***A male was considered fertile after puberty unless permanently sterile by bilateral orchidectomy, or vasectomized with confirmation of success.)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sherwin, MD, PhD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Mayo Clinic |
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A total of 15 eligible participants entered in Part 1 of study. 13 participants received a single dose of Altropane. Two subjects were not dosed due to scheduling issues. The study was planned to be conducted in 2 parts. However, due to business decisions the sponsor terminated the study after completion of Part 1. This decision was not due to safety concerns.
This study was conducted between 24 April 2023 to 08 June 2024 at 4 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Altropane (123I) Injection | Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels [MBq]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 independent expert blinded readers. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set consisted of all participants who received a single dose of Altropane.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Altropane (123I) Injection | Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels [MBq]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 independent expert blinded readers. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Striatal Visualization: Percentage of Participants With Correct Majority Classifications of 5-mCi Altropane Images as Determined by 5 Independent Blinded Readers | Assessment of the Altropane SPECT images was performed by 5 independent expert blinded readers to determine striatal uptake, reported as a forced choice of either normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced). Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers). | Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation. | Posted | Number | percentage of participants | Day 1, up to 30 minutes |
|
From administration of Altropane until 24 hours post dose
Safety Analysis Set consisted of all participants who received a single dose of Altropane.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Altropane (123I) Injection | Each participant received a single intravenous (IV) administration of 5 millicuries (mCi) (185 megabecquerels [MBq]) of Altropane (123I) Injection on Day 1. Altropane SPECT images were acquired for 30 minutes starting 15 to 20 minutes after administration with Altropane. These images were visually interpreted by 5 expert independent blinded readers. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
The study was terminated after completion of Part 1 by the Sponsor due to business decision. This decision was not due to safety concerns.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Sherwin, MD, PhD | GE HealthCare | +1 (609) 510-3686 | PaulSherwin@gehealthcare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2023 | Jun 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2023 | Jun 3, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C102282 | N-iodoallyl-2-carbomethoxy-3-(4-fluorophenyl)tropane |
| C000614958 | Iodine-123 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Day 1, up to 30 minutes |
| Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality) | Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers assessed image quality as excellent, good, fair, poor, or unevaluable. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the excellent/good and fair/poor/unevaluable groupings. Percentage of participants with image quality for 5-mCi Altropane images are reported. | Day 1, up to 30 minutes |
| Inter-Reader Agreement on Percentage of Participants With Normal Images | Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each subject's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Percentage of participants with inter-reader agreement on striatal visualization classification for whom 5, 4, and 3 readers, respectively, were in agreement on the participants classification (normal images) are reported. | Day 1, up to 30 minutes |
| Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as AEs that started or worsened between the start of pharmaceutical product administration and the end of the follow-up period. | From administration of Altropane until 24 hours post dose |
| Percentage of Participants With Adverse Drug Reaction (ADR) | ADR is an AE that is caused by the investigational medicinal product. | From administration of Altropane until 24 hours post dose |
| Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Percentage of participants with clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature). Normal limits of vital signs are:
| From administration of Altropane until 24 hours post dose |
| Percentage of Participants With Clinically Significant Changes From Baseline in Physical Examination Until 24 Hours Post Dose | Percentage of participants with clinically significant changes from baseline in physical examination (general appearance, lungs and heart). | From administration of Altropane until 24 hours post dose |
| Percentage of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Examinations (PR Interval, QTc, QRS and RR Interval) Until 24 Hours Post Dose | Percentage of participants with clinically significant changes from baseline in electrocardiogram (ECG) examinations: (PR interval, QTc, QRS and RR interval). The normal limits (ms) of ECG variables:
| From administration of Altropane until 24 hours post dose |
| Percentage of Participants With Clinically Significant Changes From Baseline in Serum Biochemistry and Hematology Parameters Until 24 Hours Post Dose | Percentage of participants with clinically significant changes from baseline in serum biochemistry (Alanine aminotransferase, Albumin, Alkaline phosphatase, Bicarbonate, Creatine phosphokinase (CPK), total Creatinine, Protein (total), Phosphorous Glucose) and hematology parameters (Red blood cell (RBC) count, Platelet count, White blood cell (WBC) count). | From administration of Altropane until 24 hours post dose |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| University of Mississippi Medical Center (UMMC) | Jackson | Mississippi | 39216 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Confidence Ratings for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Confidence in Striatal Visualization) | Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers evaluated their confidence in striatal visualization, rating it as high, medium, or low. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the high and medium/low groupings. Percentage of participants with confidence ratings for 5-mCi Altropane images are reported. | Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation. | Posted | Number | percentage of participants | Day 1, up to 30 minutes |
|
|
|
| Secondary | Percentage of Participants With Image Quality for 5-mCi Altropane Images as Evaluated by 5 Independent Blinded Readers (Reader Assessment of Image Quality) | Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each participant's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Readers assessed image quality as excellent, good, fair, poor, or unevaluable. Majority classification was determined from the majority interpretation of the 5 expert blinded readers (at least 3 of 5 readers) using the excellent/good and fair/poor/unevaluable groupings. Percentage of participants with image quality for 5-mCi Altropane images are reported. | Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation. | Posted | Number | percentage of participants | Day 1, up to 30 minutes |
|
|
|
| Secondary | Inter-Reader Agreement on Percentage of Participants With Normal Images | Visual interpretation of the Altropane SPECT images was conducted by 5 independent expert readers who were blinded to each subject's clinical information, and who were not otherwise involved in the study. Their visual image interpretations were a forced choice between normal (caudate and putamen fully visible on left and right, or with small insignificant defects) or abnormal (unilateral or bilateral reduced) striatal uptake. Percentage of participants with inter-reader agreement on striatal visualization classification for whom 5, 4, and 3 readers, respectively, were in agreement on the participants classification (normal images) are reported. | Full Analysis Set consisted of all participants who received any amount of Altropane and had an Altropane image interpretation. | Posted | Number | percentage of participants | Day 1, up to 30 minutes |
|
|
|
| Secondary | Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) | An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. Treatment-Emergent Adverse Events (TEAEs) were defined as AEs that started or worsened between the start of pharmaceutical product administration and the end of the follow-up period. | Safety Analysis Set consisted of all participants who received a single dose of Altropane. | Posted | Number | percentage of participants | From administration of Altropane until 24 hours post dose |
|
|
|
| Secondary | Percentage of Participants With Adverse Drug Reaction (ADR) | ADR is an AE that is caused by the investigational medicinal product. | Safety Analysis Set consisted of all participants who received a single dose of Altropane. | Posted | Number | percentage of participants | From administration of Altropane until 24 hours post dose |
|
|
|
| Secondary | Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs | Percentage of participants with clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature). Normal limits of vital signs are:
| Safety Analysis Set consisted of all participants who received a single dose of Altropane. | Posted | Number | percentage of participants | From administration of Altropane until 24 hours post dose |
|
|
|
| Secondary | Percentage of Participants With Clinically Significant Changes From Baseline in Physical Examination Until 24 Hours Post Dose | Percentage of participants with clinically significant changes from baseline in physical examination (general appearance, lungs and heart). | Safety Analysis Set consisted of all participants who received a single dose of Altropane. | Posted | Number | Percentage of participants | From administration of Altropane until 24 hours post dose |
|
|
|
| Secondary | Percentage of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Examinations (PR Interval, QTc, QRS and RR Interval) Until 24 Hours Post Dose | Percentage of participants with clinically significant changes from baseline in electrocardiogram (ECG) examinations: (PR interval, QTc, QRS and RR interval). The normal limits (ms) of ECG variables:
| Safety Analysis Set consisted of all participants who received a single dose of Altropane. | Posted | Number | percentage of participants | From administration of Altropane until 24 hours post dose |
|
|
|
| Secondary | Percentage of Participants With Clinically Significant Changes From Baseline in Serum Biochemistry and Hematology Parameters Until 24 Hours Post Dose | Percentage of participants with clinically significant changes from baseline in serum biochemistry (Alanine aminotransferase, Albumin, Alkaline phosphatase, Bicarbonate, Creatine phosphokinase (CPK), total Creatinine, Protein (total), Phosphorous Glucose) and hematology parameters (Red blood cell (RBC) count, Platelet count, White blood cell (WBC) count). | Safety Analysis Set consisted of all participants who received a single dose of Altropane. | Posted | Number | percentage of participants | From administration of Altropane until 24 hours post dose |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 3 |
| 13 |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
|
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| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Title | Measurements |
|---|---|
|
| Reader 2 : High |
|
| Reader 2 : Medium |
|
| Reader 2 : Low |
|
| Reader 3 : High |
|
| Reader 3 : Medium |
|
| Reader 3 : Low |
|
| Reader 4 : High |
|
| Reader 4 : Medium |
|
| Reader 4 : Low |
|
| Reader 5 : High |
|
| Reader 5 : Medium |
|
| Reader 5 : Low |
|
| Title | Measurements |
|---|---|
|
| Reader 1 : Unevaluable |
|
| Reader 2 : Excellent |
|
| Reader 2 : Good |
|
| Reader 2 : Fair |
|
| Reader 2 : Unevaluable |
|
| Reader 3 : Excellent |
|
| Reader 3 : Good |
|
| Reader 3 : Fair |
|
| Reader 3 : Unevaluable |
|
| Reader 4 : Excellent |
|
| Reader 4 : Good |
|
| Reader 4 : Fair |
|
| Reader 4 : Unevaluable |
|
| Reader 5 : Excellent |
|
| Reader 5 : Good |
|
| Reader 5 : Fair |
|
| Reader 5 : Unevaluable |
|
| Title | Measurements |
|---|---|
|