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| Name | Class |
|---|---|
| Cardero Therapeutics, Inc. | INDUSTRY |
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This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in patients with Becker muscular dystrophy who participated in the earlier trial. This single center study will enroll up to 10 adults who will receive the purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be enrolled in the study if they meet all inclusion criteria. They will be evaluated at screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the study will be presence of one or more biologic or strength and performance outcome measures that yield a response magnitude that allows for sufficient power in a Phase II B study with a sample size of 30 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | (-)-epicatechin 50mg twice per day (100mg per day total dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (-)-Epicatechin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Follistatin | blood biomarker concentration | 48 weeks |
| Plasma Myostatin | blood biomarker concentration | 48 weeks |
| Plasma Nitrates/ SNO | blood biomarker concentration | 48 weeks |
| Plasma BNP | blood biomarker concentration | 48 weeks |
| Plasma Creatine Kinase | blood biomarker concentration | 48 weeks |
| Plasma MMP-9 | blood biomarker concentration | 48 weeks |
| Plasma TNF-Alpha | blood biomarker concentration | 48 weeks |
| Plasma TGF-Beta | blood biomarker concentration | 48 weeks |
| Plasma Follistatin:Myostain Ratio | Ratio of plasma follistatin to plasma myostatin | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Graded Exercise Test Using a Recumbent Cycle Ergometer | blood lactate measured | baseline and at 2-minute intervals |
| 6-minute Walk Test | Measurements recorded will include 25-meter split times and total distance traveled. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Proteomics | Collection of plasma samples for proteomics analysis. | 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | (-)-epicatechin 50mg twice per day (100mg per day total dose) (-)-Epicatechin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | (-)-epicatechin 50mg twice per day (100mg per day total dose) (-)-Epicatechin |
| 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 | Plasma Follistatin | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
48 weeks
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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 | Treatment | (-)-epicatechin 50mg twice per day (100mg per day total dose) (-)-Epicatechin |
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Small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig McDonald, Professor and Chair | UC Davis Health | (916) 734-4293 | cmmcdonald@ucdavis.edu |
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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 | Jun 15, 2015 | Nov 15, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2015 | Apr 2, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002392 | Catechin |
| ID | Term |
|---|---|
| D002839 | Chromans |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 48 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Primary | Plasma Myostatin | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Primary | Plasma Nitrates/ SNO | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Primary | Plasma BNP | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Primary | Plasma Creatine Kinase | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Primary | Plasma MMP-9 | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Primary | Plasma TNF-Alpha | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Primary | Plasma TGF-Beta | blood biomarker concentration | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Primary | Plasma Follistatin:Myostain Ratio | Ratio of plasma follistatin to plasma myostatin | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Secondary | Graded Exercise Test Using a Recumbent Cycle Ergometer | blood lactate measured | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | baseline and at 2-minute intervals |
|
|
| Secondary | 6-minute Walk Test | Measurements recorded will include 25-meter split times and total distance traveled. | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| Other Pre-specified | Exploratory Proteomics | Collection of plasma samples for proteomics analysis. | Due to lack of funding, only 2 participants could be enrolled. The number of evaluable patients was insufficient to perform analysis of this outcome measure. | Posted | 48 weeks |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 |
| Heterocyclic Compounds |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |