Trial · NCT00441896
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
NCT00441896, Phase 2, Completed, Marinus Pharmaceuticals; results first posted 2023-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms. Trials, record NCT00441896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00441896
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
- NCT number
- NCT00441896
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Marinus Pharmaceuticals
- Conditions
- Infantile Spasms
- Interventions
- Ganaxolone, Placebo
- First posted
- 2007-03-01
- Last updated
- 2023-06-02
- Results first posted
- 2023-06-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Frequency of Spasm Clusters at Day 10 | Baseline (Day 0) and Day 10 | Spasm clusters were determined by a 24-hour video-electroencephalography (vEEG) at Day 10. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the Day 0 assessment before study drug infusion. |
| Secondary | Change From Baseline in Frequency of Spasm Clusters at Day 20 | Baseline (Day 0) and Day 20 | Spasm clusters were determined by a 24-hour vEEG at Day 20. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the Day 0 assessment before study drug infusion. |
| Secondary | Number of Participants With Absence of Hypsarrhythmia | Day 10 and Day 20 | Absence of hypsarrhythmia was determined by 24-hour vEEG at Day 10 and Day 20. |
| Secondary | Number of Participants With Change in Clinical Status on the Investigator's Global Assessment | Baseline (Day 0), Day 10 and Day 20 | The investigators rated the participants' overall clinical status based on 7 clinical factors: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (\[1\] marked improvement, \[2\] moderate improvement, \[3\] slight improvement, \[4\] no change from Baseline, \[5\] slight worsening, \[6\] moderate worsening, or \[7\] marked worsening). Higher score indicated worse symptoms. The investigators assessed the participants' status compared to their condition prior to initiating study medication. |
| Secondary | Number of Participants With Change in Clinical Status on Caregiver's Global Assessment | Baseline (Day 0), Day10 and Day 20 | Caregiver global assessment of seizure severity and response to treatment rated the participants' based on 7 clinical factors: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (\[1\] marked improvement, \[2\] moderate improvement, \[3\] slight improvement, \[4\] no change from Baseline, \[5\] slight worsening, \[6\] moderate worsening, or \[7\] marked worsening). Higher score indicated worse symptoms. The assessment compared the participants' current status to their condition prior to initiating study medication. |
| Secondary | Number of Participants With Spasm-free Durations | Day 10 and Day 20 | Clinical spasms were determined by vEEG for at least 24 hours at Day 10 and Day 20. The number of participants with spasm-free duration have been presented. |
| Secondary | Number of Participants With Seizure-free Days | From Day 8 to Day 10 and From Day 18 to Day 20 | Seizure-free days were measured using data obtained from participants' daily dairy. Participants without seizures have been reported. |
| Secondary | Number of Responders | Day 10 and Day 20 | A responder is defined as a participant experiencing a greater than equal to (\>=) 50 percent (%) decrease in spasm frequency. Test for responders was conducted by vEEG for up to 24 hours at Day 10 and Day 20 |
| Secondary | Developmental Assessment Using Denver-II Developmental Test at Day 20 | At Day 20 | Denver-II Developmental Test measures a child's development in several areas:Personal-Social,Fine Motor-Adaptive,Language,and Gross Motor,from birth to 6 years old.It consists of 125 items that are organized into subscales and scored as pass,fail,or refused.To evaluate a child's progress,test compares their performance to a normative sample of children of same age.For each item,age at which 90% of children in normative sample pass it is determined.Derived score for each subscale is sum of item scores and represents difference between child's chronological age and age at which 90% of children in normative sample pass the items in that subscale.A higher derived score on a subscale indicates better performance on items in that subscale relative to other children of same age who have taken the test.Among subscales,Personal-Social subscale ranges from -16 months to 24 months;others range from - 12 months to 24 months.All subscales have a population mean of 0 and a standard deviation of 3. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Frequency of Spasm Clusters at Day 10 | Baseline (Day 0) and Day 10 | Efficacy Population included all randomized participants who received at least 1 evaluation of efficacy at both Baseline (Day 0) and at either Visit 5 (Day 10) or Visit 8 (Day 20). Only those participants with data available at the indicated time point were analyzed. | Spasm clusters per day | MEAN |
| SECONDARY | Change From Baseline in Frequency of Spasm Clusters at Day 20 | Baseline (Day 0) and Day 20 | Efficacy Population. | Spasm clusters per day | MEAN |
| SECONDARY | Number of Participants With Absence of Hypsarrhythmia | Day 10 and Day 20 | Efficacy Population. Only those participants with data available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change in Clinical Status on the Investigator's Global Assessment | Baseline (Day 0), Day 10 and Day 20 | Efficacy Population. Only those participants with data available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change in Clinical Status on Caregiver's Global Assessment | Baseline (Day 0), Day10 and Day 20 | Efficacy population. Only those participants with data available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Spasm-free Durations | Day 10 and Day 20 | Efficacy Population. Only those participants with data available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Seizure-free Days | From Day 8 to Day 10 and From Day 18 to Day 20 | Efficacy Population. Only those participants with data available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Responders | Day 10 and Day 20 | Efficacy Population. Only those participants with data available at the indicated time point were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Developmental Assessment Using Denver-II Developmental Test at Day 20 | At Day 20 | Efficacy Population. Only those participants with data available at the indicated time point were analyzed. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group420
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 1: Sequence A: Ganaxolone/Placebo/Ganaxolone | 1.0 | Standard Deviation 20.06 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 1: Sequence B: Placebo/Ganaxolone/Placebo | 2.7 | Standard Deviation 6.66 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 2: Sequence A: Ganaxolone/Placebo/Ganaxolone | -5.4 | Standard Deviation 10.97 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 2: Sequence B: Placebo/Ganaxolone/Placebo | -1.0 | Standard Deviation 1.83 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 3: Sequence A: Ganaxolone/Placebo/Ganaxolone | -1.4 | Standard Deviation 13.69 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 3: Sequence B: Placebo/Ganaxolone/Placebo | -5.3 | Standard Deviation 10.12 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 4: Sequence A: Ganaxolone/Placebo/Ganaxolone | -3.7 | Standard Deviation 4.92 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 4: Sequence B: Placebo/Ganaxolone/Placebo | 0.2 | Standard Deviation 13.12 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 5: Sequence A: Ganaxolone/Placebo/Ganaxolone | -3.2 | Standard Deviation 5.02 | Spasm clusters per day | |
| Change From Baseline in Frequency of Spasm Clusters at Day 10 | Cohort 5: Sequence B: Placebo/Ganaxolone/Placebo | -1.7 | Standard Deviation 7.64 | Spasm clusters per day |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Sequence A: Ganaxolone/Placebo/Ganaxolone | 6 | |
| Overall Study | STARTED | Cohort 1: Sequence B: Placebo/Ganaxolone/Placebo | 3 | |
| Overall Study | STARTED | Cohort 2: Sequence A: Ganaxolone/Placebo/Ganaxolone | 7 | |
| Overall Study | STARTED | Cohort 2: Sequence B: Placebo/Ganaxolone/Placebo | 4 | |
| Overall Study | STARTED | Cohort 3: Sequence A: Ganaxolone/Placebo/Ganaxolone | 12 | |
| Overall Study | STARTED | Cohort 3: Sequence B: Placebo/Ganaxolone/Placebo | 3 | |
| Overall Study | STARTED | Cohort 4: Sequence A: Ganaxolone/Placebo/Ganaxolone | 7 | |
| Overall Study | STARTED | Cohort 4: Sequence B: Placebo/Ganaxolone/Placebo | 5 | |
| Overall Study | STARTED | Cohort 5: Sequence A: Ganaxolone/Placebo/Ganaxolone | 6 | |
| Overall Study | STARTED | Cohort 5: Sequence B: Placebo/Ganaxolone/Placebo | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events510
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Cohort 1: Sequence A: Ganaxolone/Placebo/Ganaxolone | 2 | 6 | |
| other | Somnolence | Nervous system disorders | Cohort 1: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 3 | |
| other | Somnolence | Nervous system disorders | Cohort 2: Sequence A: Ganaxolone/Placebo/Ganaxolone | 1 | 7 | |
| other | Somnolence | Nervous system disorders | Cohort 2: Sequence B: Placebo/Ganaxolone/Placebo | 1 | 4 | |
| other | Somnolence | Nervous system disorders | Cohort 3: Sequence A: Ganaxolone/Placebo/Ganaxolone | 0 | 11 | |
| other | Somnolence | Nervous system disorders | Cohort 3: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 3 | |
| other | Somnolence | Nervous system disorders | Cohort 4: Sequence A: Ganaxolone/Placebo/Ganaxolone | 1 | 7 | |
| other | Somnolence | Nervous system disorders | Cohort 4: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 5 | |
| other | Somnolence | Nervous system disorders | Cohort 5: Sequence A: Ganaxolone/Placebo/Ganaxolone | 0 | 6 | |
| other | Somnolence | Nervous system disorders | Cohort 5: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 4 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Sequence A: Ganaxolone/Placebo/Ganaxolone | 0 | 6 |
| Total, all-cause mortality | Cohort 1: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 3 |
| Total, all-cause mortality | Cohort 2: Sequence A: Ganaxolone/Placebo/Ganaxolone | 0 | 7 |
| Total, all-cause mortality | Cohort 2: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 4 |
| Total, all-cause mortality | Cohort 3: Sequence A: Ganaxolone/Placebo/Ganaxolone | 0 | 11 |
| Total, all-cause mortality | Cohort 3: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 3 |
| Total, all-cause mortality | Cohort 4: Sequence A: Ganaxolone/Placebo/Ganaxolone | 0 | 7 |
| Total, all-cause mortality | Cohort 4: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 5 |
| Total, all-cause mortality | Cohort 5: Sequence A: Ganaxolone/Placebo/Ganaxolone | 0 | 6 |
| Total, all-cause mortality | Cohort 5: Sequence B: Placebo/Ganaxolone/Placebo | 0 | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00441896
GET https://conductscience.org/api/trials/v1/NCT00441896/results?page=2