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Based on scientific data collected during the trial and high screen fail rate.
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| Name | Class |
|---|---|
| Ferox Therapeutics | INDUSTRY |
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The primary objective of this study is to determine the safety, tolerability and pharmacodynamics of pitolisant in patients with Type 1 Diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitolisant | Experimental |
| |
| Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitolisant | Drug | Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peak Glucagon Response to Hypoglycemia | Change in peak glucagon concentration from day 1 ITT (baseline) to day 7 ITT (on treatment). Serial glucagon collected during ITT's, occurred at -10, 0, 15, 30, 45, 60, 90, 120 and 180 minutes just prior to and during the ITT. | Change in peak glucagon during ITT Day 1 vs. Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Returning to Blood Glucose =>70 mg/dL | Number of patients that returned to blood glucose =>70 mg/dL during ITT | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Fein, MD | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitolisant 36mg | 2-18mg tablets once daily for 7 days |
| FG001 | Placebo | 2- Placebo tablets to match pitolisant 18mg once daily for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitolisant 36mg | 2-18 mg tablets per day for 7 days |
| BG001 | Placebo | 2-Placebo to match 18mg of pitolisant |
| 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 | Change From Baseline in Peak Glucagon Response to Hypoglycemia | Change in peak glucagon concentration from day 1 ITT (baseline) to day 7 ITT (on treatment). Serial glucagon collected during ITT's, occurred at -10, 0, 15, 30, 45, 60, 90, 120 and 180 minutes just prior to and during the ITT. | Posted | Mean | 95% Confidence Interval | pg/mL | Change in peak glucagon during ITT Day 1 vs. Day 7 |
|
Day 1 to day 16
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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 | Pitolisant 36mg | 2-18 mg tablets per day for 7 days | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment | Blood Glucose < 70 mg/dL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melanie Fein, MD | High Point Clinical Trials Center | 1-336-841-0700 | 2530 | mfein@highpointctc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2019 | Mar 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C516975 | pitolisant |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Patients Returning to Blood Glucose =>70 mg/dL | Number of patients that returned to blood glucose =>70 mg/dL during ITT | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Placebo | 2-Placebo to match 18mg of pitolisant | 0 | 2 | 0 | 2 | 2 | 2 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |