Trial Outcomes & Findings for An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches. (NCT NCT00203242)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

baseline (day 0) through 47 days after first infusion

Results posted on

2011-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Depacon IV and Depakote Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Depacon IV and Depakote Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
Overall Study Lost to Follow-up	1

Baseline Characteristics

An Open Label Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depacon IV and Depakote n=15 Participants Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	40.8 years STANDARD_DEVIATION 10.8 • n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Depacon IV and Depakote n=15 Participants Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
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.	29.7 days Standard Deviation 13.8

SECONDARY outcome

Timeframe: Compare Baseline through 47 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline compared to maintenance (up to 47 days)

Outcome measures

Outcome data not reported

Adverse Events

Depacon IV and Depakote

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Depacon IV and Depakote n=15 participants at risk Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
Metabolism and nutrition disorders cool sensation	13.3% 2/15
Nervous system disorders Tiredness	20.0% 3/15
Gastrointestinal disorders Nausea	6.7% 1/15
Nervous system disorders Taste perversion	6.7% 1/15
Nervous system disorders Warm sensation	6.7% 1/15
Nervous system disorders Lightheadedness	6.7% 1/15
Metabolism and nutrition disorders Increased appetite	6.7% 1/15

Additional Information

Stephen D. Silberstein-Principal Investigator

Thomas Jefferson University/Jefferson Headache Center

Phone: 215-955-9477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place