Trial · NCT01607073
Verapamil as Therapy for Children and Young Adults With Dravet Syndrome
NCT01607073, Phase 2, Completed, Gillette Children's Specialty Healthcare; results first posted 2021-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Verapamil as Therapy for Children and Young Adults With Dravet Syndrome. Trials, record NCT01607073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01607073
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Verapamil as Therapy for Children and Young Adults With Dravet Syndrome
- NCT number
- NCT01607073
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Gillette Children's Specialty Healthcare
- Conditions
- Dravet Syndrome
- Interventions
- Verapamil
- First posted
- 2012-05-28
- Last updated
- 2021-04-13
- Results first posted
- 2021-03-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit | Week 8 (baseline) to Week 12 | The primary study endpoint is the change in number of seizures from baseline. Since we only had one participant finish the study, the endpoint was changed to Week 12 visit. Participants were on verapamil for 4 weeks at Week 12. |
| Secondary | Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12 | Week 8 (baseline) to Week 12 | The secondary outcome is the change in number of myoclonic seizures between baseline Week 8 visit and Week 12 visit. |
| Secondary | Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12 | Week 8 to Week 12 | The secondary outcome measure is the change in number of absence seizures from Week 8 (Baseline) to Week 12 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit | Week 8 (baseline) to Week 12 | Change in number of general tonic-clonic seizures between Week 8 (baseline) and Week 12 visits. | General tonic-clonic seizures | NUMBER |
| SECONDARY | Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12 | Week 8 (baseline) to Week 12 | Participant's collected number of myoclonic seizures at Week 8 visit (baseline) prior to taking verapamil and at Week 12 after 4 weeks of taking verapamil. This participant was the only participant who had seizure types other than general tonic-clonic seizures. | Myoclonic seizures | NUMBER |
| SECONDARY | Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12 | Week 8 to Week 12 | Number of Abscence seizures from Week 8 (baseline) to Week 12 visits. | Abscence seizures | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit | Week 8 Baseline | 39 | General tonic-clonic seizures | ||
| Change in Number of General Tonic-clonic Seizures From Week 8 (Baseline) Visit to Week 12 Visit | Week 12 Verapamil 4mg/kg/Day | 14 | General tonic-clonic seizures | ||
| Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12 | Week 8 Baseline | 116 | Myoclonic seizures | ||
| Change in Number of Myoclonic Seizures From Week 8 (Baseline) to Week 12 | Week 12 Verapamil 4mg/kg/Day | 175 | Myoclonic seizures | ||
| Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12 | Week 8 Baseline | 165 | Abscence seizures | ||
| Change in Number of Absence Seizures From Week 8 (Baseline) to Week 12 | Week 12 Verapamil 4mg/kg/Day | 101 | Abscence seizures |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adjunctive Verapamil | 2 | |
| Overall Study | COMPLETED | Adjunctive Verapamil | 1 | |
| Overall Study | NOT COMPLETED | Adjunctive Verapamil | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | Insomnia | Nervous system disorders | Open Label Adjunctive Add on | 1 | 2 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Open Label Adjunctive Add on | 1 | 2 | 1 |
| other | Drooling | Nervous system disorders | Open Label Adjunctive Add on | 1 | 2 | 1 |
| serious | Seizure | Nervous system disorders | Open Label Adjunctive Add on | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label Adjunctive Add on | ||
| Total, other adverse events | Open Label Adjunctive Add on | 2 | 2 |
| Total, serious adverse events | Open Label Adjunctive Add on | 1 | 2 |
Source ClinicalTrials.gov
Papers36
The papers the trial lists on ClinicalTrials.gov.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01607073
GET https://conductscience.org/api/trials/v1/NCT01607073/papers?page=2