Trial · NCT00203242
An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches.
NCT00203242, Not applicable, Completed, Thomas Jefferson University; results first posted 2011-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches. Trials, record NCT00203242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00203242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches.
- NCT number
- NCT00203242
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 15 participants, actual
- Lead sponsor
- Thomas Jefferson University
- Conditions
- Cluster Headache
- Interventions
- Depacon IV and Depakote ER
- First posted
- 2005-09-20
- Last updated
- 2011-07-15
- Results first posted
- 2011-07-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline. | baseline (day 0) through 47 days after first infusion | Severity: measured on an 11 point scale, where 0 = no pain and 10= excruciating pain. Outcome is time to 50% reduction in severity (or frequency) compared to baseline (prior to treatment).Frequency: Number of attacks per day.The Time to significant response was measured 2 ways: significant initial response and significant maintained response. For initial response, the time to significant response was: Mean of 2.1(1.5) days for severity and 1.9 (1.6) days for frequency. The time to significant response maintained was 29.7 (13.8) for severity and 29.0 (14.3) for frequency. |
| Secondary | Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values. | Compare Baseline through 47 days | |
| Secondary | Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days. | Baseline compared to maintenance (up to 47 days) |
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 | Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline. | baseline (day 0) through 47 days after first infusion | days | MEAN | |
| SECONDARY | Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values. | Compare Baseline through 47 days | days | NUMBER | |
| SECONDARY | Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days. | Baseline compared to maintenance (up to 47 days) | number doses | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline. | Depacon IV and Depakote | 29.7 | Standard Deviation 13.8 | days |
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 | Depacon IV and Depakote | 15 | |
| Overall Study | COMPLETED | Depacon IV and Depakote | 14 | |
| Overall Study | NOT COMPLETED | Depacon IV and Depakote | 1 |
Source ClinicalTrials.gov
Adverse events7
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 | cool sensation | Metabolism and nutrition disorders | Depacon IV and Depakote | 2 | 15 | |
| other | Tiredness | Nervous system disorders | Depacon IV and Depakote | 3 | 15 | |
| other | Nausea | Gastrointestinal disorders | Depacon IV and Depakote | 1 | 15 | |
| other | Taste perversion | Nervous system disorders | Depacon IV and Depakote | 1 | 15 | |
| other | Warm sensation | Nervous system disorders | Depacon IV and Depakote | 1 | 15 | |
| other | Lightheadedness | Nervous system disorders | Depacon IV and Depakote | 1 | 15 | |
| other | Increased appetite | Metabolism and nutrition disorders | Depacon IV and Depakote | 1 | 15 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Depacon IV and Depakote | ||
| Total, other adverse events | Depacon IV and Depakote | 7 | 15 |
| Total, serious adverse events | Depacon IV and Depakote | 0 | 15 |
Source ClinicalTrials.gov
Papers0
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
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/NCT00203242
GET https://conductscience.org/api/trials/v1/NCT00203242/registered