Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NINDS NS39466 | |||
| CRC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Columbia University | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
| Emory University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this investigation was to determine if cyclic adjunctive progesterone supplement is superior to placebo in the treatment of intractable seizures in women with and without catamenial epilepsy.
This is a 6-month study. The first 3 months will gather baseline information on seizures, antiepileptic drug levels , menstrual cycles, hormone levels, emotional function, and quality of life. The second 3 months will assess the effects of treatment on these parameters.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catamenial Epilepsy: Progesterone Lozenges | Experimental | Subjects with catamenial epilepsy received 200 mg progesterone lozenges |
|
| Catamenial Epilepsy: Placebo Lozenges | Placebo Comparator | Subjects with catamenial epilepsy received matched placebo lozenges |
|
| Noncatamenial Epilespy:Progesterone Lozenges | Experimental | Subjects without catamenial epilepsy received 200 mg progesterone lozenges |
|
| Noncatamenial Epilespy: Placebo Lozenges | Placebo Comparator | Subjects without catamenial epilepsy received matched placebo lozenges |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone Lozenges | Biological | 200mg Progesterone Lozenges |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency | Percent of women who show a greater than 50% decline in average daily seizure frequency | 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type. | Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type. | 9 years |
| Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately |
Not provided
INCLUSION:
EXCLUSION:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew G Herzog, M.D., M.Sc. | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California, Keck School of Medicine | Los Angeles | California | 90033 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7675223 | Background | Herzog AG. Progesterone therapy in women with complex partial and secondary generalized seizures. Neurology. 1995 Sep;45(9):1660-2. doi: 10.1212/wnl.45.9.1660. | |
| 10371551 | Background | Herzog AG. Progesterone therapy in women with epilepsy: a 3-year follow-up. Neurology. 1999 Jun 10;52(9):1917-8. doi: 10.1212/wnl.52.9.1917-a. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Catamenial Epilepsy: Progesterone Lozenges | Subjects with catamenial epilepsy received 200 mg progesterone lozenges |
| FG001 | Catamenial Epilepsy: Placebo Lozenges | Subjects with catamenial epilepsy received matched placebo lozenges |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| OTHER |
| Johns Hopkins University | OTHER |
| Montreal Neurological Institute and Hospital | OTHER |
| Ohio State University | OTHER |
| Thomas Jefferson University | OTHER |
| University of Maryland | OTHER |
| University of Southern California | OTHER |
| University of Virginia | OTHER |
| Weill Medical College of Cornell University | OTHER |
| Minnesota Comprehensive Epilepsy Program | UNKNOWN |
This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Randomization was carried out separately for women with and without catamenial epilepsy, 2:1 to progesterone or placebo.
Not provided
Not provided
Not provided
| Matched Placebo Lozenges | Other | Matched Placebo Lozenges |
|
Percentage of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately |
| 9 years |
| Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment. | Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo. | 9 years |
| Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy. | 9 years |
| Emory University School of Medicine |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| MINCEP Epilepsy Care | Minneapolis | Minnesota | 55416 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center | New York | New York | 10021 | United States |
| Columbia Medical Center | New York | New York | 10032 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Thomas Jefferson University Hospital, Comprehensive Epilepsy Center | Philadelphia | Pennsylvania | 19107 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Montreal Neurological Institute | Montreal | Quebec | H3A 2B4 | Canada |
| 9579954 | Background | Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia. 1997 Oct;38(10):1082-8. doi: 10.1111/j.1528-1157.1997.tb01197.x. |
| 15349872 | Result | Herzog AG, Harden CL, Liporace J, Pennell P, Schomer DL, Sperling M, Fowler K, Nikolov B, Shuman S, Newman M. Frequency of catamenial seizure exacerbation in women with localization-related epilepsy. Ann Neurol. 2004 Sep;56(3):431-4. doi: 10.1002/ana.20214. |
| 34528245 | Derived | Maguire MJ, Nevitt SJ. Treatments for seizures in catamenial (menstrual-related) epilepsy. Cochrane Database Syst Rev. 2021 Sep 16;9(9):CD013225. doi: 10.1002/14651858.CD013225.pub3. |
| FG002 | Noncatamenial Epilespy:Progesterone Lozenges | Subjects without catamenial epilepsy received 200 mg progesterone lozenges |
| FG003 | Noncatamenial Epilespy: Placebo Lozenges | Subjects without catamenial epilepsy received matched placebo lozenges |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Catamenial Epilepsy: Progesterone Lozenges | Subjects with catamenial epilepsy received 200 mg progesterone lozenges |
| BG001 | Catamenial Epilepsy: Placebo Lozenges | Subjects with catamenial epilepsy received matched placebo lozenges |
| BG002 | Noncatamenial Epilespy:Progesterone Lozenges | Subjects without catamenial epilepsy received 200 mg progesterone lozenges |
| BG003 | Noncatamenial Epilespy: Placebo Lozenges | Subjects without catamenial epilepsy received matched placebo lozenges |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency | Percent of women who show a greater than 50% decline in average daily seizure frequency | Posted | Number | percentage of participants | 9 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type. | Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type. | Posted | Number | percentage of participants | 9 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency for Secondary Generalized, Complex Partial and Simple Partial Seizures Considered Separately | Percentage of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately | Posted | Number | percentage of participants | 9 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment. | Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo. | Posted | Median | Inter-Quartile Range | ng/ml | 9 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy. | Posted | Mean | Standard Deviation | mcg/mL | 9 years |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catamenial Epilepsy: Progesterone Lozenges | Subjects with catamenial epilepsy received 200 mg progesterone lozenges | 0 | 85 | 3 | 85 | 37 | 85 |
| EG001 | Catamenial Epilepsy: Placebo Lozenges | Subjects with catamenial epilepsy received matched placebo lozenges | 0 | 45 | 1 | 45 | 23 | 45 |
| EG002 | Noncatamenial Epilespy:Progesterone Lozenges | Subjects without catamenial epilepsy received 200 mg progesterone lozenges | 1 | 105 | 3 | 105 | 55 | 105 |
| EG003 | Noncatamenial Epilespy: Placebo Lozenges | Subjects without catamenial epilepsy received matched placebo lozenges | 0 | 59 | 2 | 59 | 27 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | SUDEP |
| |
| Hospitalization | General disorders | Systematic Assessment | Seizures |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysepepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
| ||
| Vomiting | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders |
| |||
| Nasopharyngitis | General disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew G. Herzog | Beth Israel Deaconess Medical Center | 781-431-0277 | aherzog@bidmc.harvard.edu |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|