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The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.
This is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose disorder symptoms have improved with the use of these medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion & Citalopram | Experimental | 100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day |
|
| Bupropion & Placebo | Active Comparator | 100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day |
|
| Placebo & Citalopram | Active Comparator | Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day |
|
| Placebo & Placebo | Placebo Comparator | Placebo & Placebo taken orally one time per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupropion & Citalopram | Drug |
| ||
| Bupropion & Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| International Cooperative Ataxia Rating Scale (ICARS) | The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease. | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion) |
| Friedreich Ataxia Rating Scale (FARS) | A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease. | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of FARS and ICARS | Differences between FARS - ICARS at each treatment interval | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale | The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression. | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Klepitskaya, MD | University of Colorado, Denver | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participant | the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participant | the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | International Cooperative Ataxia Rating Scale (ICARS) | The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease. | Posted | Number | units | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion) |
|
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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 | Bupropion & Citalopram | 100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day bupropion & Citalopram |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olga Klepitskaya | University of Colorado | 303-724-8984 | olga.klepitskaya@ucdenver.edu |
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| ID | Term |
|---|---|
| D005621 | Friedreich Ataxia |
| ID | Term |
|---|---|
| D013132 | Spinocerebellar Degenerations |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
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|
| Placebo & Citalopram | Drug |
|
| Placebo & Placebo | Drug |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Bupropion & Placebo |
100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day Bupropion & Placebo |
| OG002 | Placebo & Citalopram | Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day Placebo & Citalopram |
| OG003 | Placebo & Placebo | Placebo & Placebo taken orally one time per day Placebo & Placebo |
| OG004 | Baseline | unblinded 100mg Bupropion & 20mg Citalopram |
|
|
| Primary | Friedreich Ataxia Rating Scale (FARS) | A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease. | Posted | Number | points | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) |
|
|
|
| Secondary | Comparison of FARS and ICARS | Differences between FARS - ICARS at each treatment interval | Posted | Number | points | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) |
|
|
|
| Other Pre-specified | Hamilton Depression Rating Scale | The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression. | Posted | Number | units on a scale | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Bupropion & Placebo | 100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day Bupropion & Placebo | 0 | 1 | 0 | 1 |
| EG002 | Placebo & Citalopram | Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day Placebo & Citalopram | 0 | 1 | 0 | 1 |
| EG003 | Placebo & Placebo | Placebo & Placebo taken orally one time per day Placebo & Placebo | 0 | 1 | 0 | 1 |
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| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000588 |
| Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |