Trial Outcomes & Findings for Progesterone vs Placebo Therapy for Women With Epilepsy (NCT NCT00029536)
NCT ID: NCT00029536
Last Updated: 2017-06-05
Results Overview
Percent of women who show a greater than 50% decline in average daily seizure frequency
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
294 participants
Primary outcome timeframe
9 years
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
Subjects without catamenial epilepsy received matched placebo lozenges
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
45
|
105
|
59
|
|
Overall Study
COMPLETED
|
85
|
45
|
105
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Progesterone vs Placebo Therapy for Women With Epilepsy
Baseline characteristics by cohort
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=85 Participants
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=45 Participants
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
n=105 Participants
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
n=59 Participants
Subjects without catamenial epilepsy received matched placebo lozenges
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
32.31 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
30.71 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
32.42 years
STANDARD_DEVIATION 7.87 • n=4 Participants
|
31.71 years
STANDARD_DEVIATION 8.30 • n=21 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
294 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 9 yearsPercent of women who show a greater than 50% decline in average daily seizure frequency
Outcome measures
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=85 Participants
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=45 Participants
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
n=105 Participants
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
n=59 Participants
Subjects without catamenial epilepsy received matched placebo lozenges
|
|---|---|---|---|---|
|
Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
|
22.8 percentage of participants
|
20.0 percentage of participants
|
20.2 percentage of participants
|
19.2 percentage of participants
|
SECONDARY outcome
Timeframe: 9 yearsPercent of women who show a \>50% decline in average daily seizure frequency for the most severe seizure type.
Outcome measures
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=85 Participants
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=45 Participants
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
n=105 Participants
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
n=59 Participants
Subjects without catamenial epilepsy received matched placebo lozenges
|
|---|---|---|---|---|
|
Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.
|
30.4 percentage of participants
|
24.4 percentage of participants
|
22.2 percentage of participants
|
28.8 percentage of participants
|
SECONDARY outcome
Timeframe: 9 yearsPercentage 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
Outcome measures
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=85 Participants
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=45 Participants
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
n=105 Participants
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
n=59 Participants
Subjects without catamenial epilepsy received 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
SGMS
|
39.39 percentage of participants
|
29.41 percentage of participants
|
21.21 percentage of participants
|
20.83 percentage of participants
|
|
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
CPS
|
23.68 percentage of participants
|
18.60 percentage of participants
|
21.21 percentage of participants
|
13.73 percentage of participants
|
|
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
SPS
|
41.12 percentage of participants
|
41.21 percentage of participants
|
42.22 percentage of participants
|
31.82 percentage of participants
|
SECONDARY outcome
Timeframe: 9 yearsChanges in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.
Outcome measures
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=85 Participants
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=45 Participants
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
n=105 Participants
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
n=59 Participants
Subjects without catamenial epilepsy received matched placebo lozenges
|
|---|---|---|---|---|
|
Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.
Baseline
|
9.8 ng/ml
Interval 5.8 to 12.0
|
9.1 ng/ml
Interval 5.9 to 12.9
|
10.8 ng/ml
Interval 7.3 to 13.1
|
9.1 ng/ml
Interval 6.5 to 12.4
|
|
Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.
Treatment
|
44.4 ng/ml
Interval 28.9 to 87.9
|
9.2 ng/ml
Interval 5.1 to 13.7
|
49.6 ng/ml
Interval 27.0 to 88.25
|
12.0 ng/ml
Interval 7.5 to 14.0
|
SECONDARY outcome
Timeframe: 9 yearsOutcome measures
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=66 Participants
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=37 Participants
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
Subjects without catamenial epilepsy received matched placebo lozenges
|
|---|---|---|---|---|
|
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.
Carbamazepine
|
8.9 mcg/mL
Standard Deviation 2.5
|
9.6 mcg/mL
Standard Deviation 1.8
|
—
|
—
|
|
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.
Levitracetam
|
23.2 mcg/mL
Standard Deviation 17.1
|
22.6 mcg/mL
Standard Deviation 12.5
|
—
|
—
|
|
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.
Lamotrigine
|
11.1 mcg/mL
Standard Deviation 8.2
|
8.4 mcg/mL
Standard Deviation 4.8
|
—
|
—
|
|
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.
Topirimate
|
10.9 mcg/mL
Standard Deviation 6.9
|
9.3 mcg/mL
Standard Deviation 4.6
|
—
|
—
|
|
Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.
Phenytoin
|
19.7 mcg/mL
Standard Deviation 6.5
|
17.9 mcg/mL
Standard Deviation 3.9
|
—
|
—
|
Adverse Events
Catamenial Epilepsy: Progesterone Lozenges
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Catamenial Epilepsy: Placebo Lozenges
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Noncatamenial Epilespy:Progesterone Lozenges
Serious events: 3 serious events
Other events: 55 other events
Deaths: 1 deaths
Noncatamenial Epilespy: Placebo Lozenges
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=85 participants at risk
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=45 participants at risk
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
n=105 participants at risk
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
n=59 participants at risk
Subjects without catamenial epilepsy received matched placebo lozenges
|
|---|---|---|---|---|
|
General disorders
Death
|
1.2%
1/85 • Number of events 1
|
0.00%
0/45
|
0.00%
0/105
|
0.00%
0/59
|
|
General disorders
Hospitalization
|
2.4%
2/85 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
2.9%
3/105 • Number of events 3
|
3.4%
2/59 • Number of events 2
|
Other adverse events
| Measure |
Catamenial Epilepsy: Progesterone Lozenges
n=85 participants at risk
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
|
Catamenial Epilepsy: Placebo Lozenges
n=45 participants at risk
Subjects with catamenial epilepsy received matched placebo lozenges
|
Noncatamenial Epilespy:Progesterone Lozenges
n=105 participants at risk
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
|
Noncatamenial Epilespy: Placebo Lozenges
n=59 participants at risk
Subjects without catamenial epilepsy received matched placebo lozenges
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
4/85 • Number of events 4
|
8.9%
4/45 • Number of events 4
|
2.9%
3/105 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
|
Gastrointestinal disorders
Dysepepsia
|
2.4%
2/85 • Number of events 2
|
4.4%
2/45 • Number of events 2
|
1.9%
2/105 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
|
General disorders
Nausea
|
0.00%
0/85
|
6.7%
3/45 • Number of events 3
|
1.9%
2/105 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
|
General disorders
Vomiting
|
2.4%
2/85 • Number of events 2
|
4.4%
2/45 • Number of events 2
|
3.8%
4/105 • Number of events 4
|
6.8%
4/59 • Number of events 4
|
|
General disorders
Fatigue
|
16.5%
14/85 • Number of events 14
|
11.1%
5/45 • Number of events 5
|
15.2%
16/105 • Number of events 16
|
15.3%
9/59 • Number of events 9
|
|
General disorders
Nasopharyngitis
|
0.00%
0/85
|
2.2%
1/45 • Number of events 1
|
0.00%
0/105
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/85
|
0.00%
0/45
|
1.9%
2/105 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
|
General disorders
Dizziness
|
3.5%
3/85 • Number of events 3
|
13.3%
6/45 • Number of events 6
|
6.7%
7/105 • Number of events 7
|
5.1%
3/59 • Number of events 3
|
|
General disorders
Headache
|
3.5%
3/85 • Number of events 3
|
4.4%
2/45 • Number of events 2
|
2.9%
3/105 • Number of events 3
|
6.8%
4/59 • Number of events 4
|
|
Psychiatric disorders
Depression
|
4.7%
4/85 • Number of events 4
|
2.2%
1/45 • Number of events 1
|
6.7%
7/105 • Number of events 7
|
3.4%
2/59 • Number of events 2
|
|
General disorders
Other
|
5.9%
5/85 • Number of events 5
|
0.00%
0/45
|
8.6%
9/105 • Number of events 9
|
0.00%
0/59
|
Additional Information
Dr. Andrew G. Herzog
Beth Israel Deaconess Medical Center
Phone: 781-431-0277
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place