Trial Outcomes & Findings for Lacosamide in Preventing Seizures in Participants With Malignant Glioma (NCT NCT01432171)

Last Updated: 2018-12-19

Results Overview

Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)

Recruitment status

TERMINATED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

12 months or first seizure

Results posted on

2018-12-19

Participant Flow

Recruitment Period: July 25, 2012 to May 23, 2016. All recruitment done in medical clinical settings.

Participant milestones

Participant milestones
Measure	Lacosamide (Vimpat) Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks	Placebo Placebo orally twice a day.
Overall Study STARTED	18	19
Overall Study COMPLETED	4	8
Overall Study NOT COMPLETED	14	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Lacosamide (Vimpat) Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks	Placebo Placebo orally twice a day.
Overall Study Death	1	2
Overall Study Lost to Follow-up	6	5
Overall Study Withdrawal by Subject	3	1
Overall Study Noncompliance	2	3
Overall Study Insurance denial trial coverage	1	0
Overall Study Patient moved to palliative care	1	0

Baseline Characteristics

Lacosamide in Preventing Seizures in Participants With Malignant Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lacosamide n=18 Participants Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks	Placebo n=19 Participants Placebo orally twice a day.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 12 • n=5 Participants	60 years STANDARD_DEVIATION 10 • n=7 Participants	57 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months or first seizure

Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)

Outcome measures

Outcome measures
Measure	Lacosamide n=18 Participants Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks	Placebo n=19 Participants Placebo orally twice a day.
Number of Participants With Seizures	0 Participants	1 Participants

Adverse Events

Lacosamide

Serious events: 2 serious events

Other events: 16 other events

Deaths: 1 deaths

Placebo

Serious events: 6 serious events

Other events: 17 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Andrew Norden, M.D., M.P.H. - Lead Principal Investigator

Dana-Farber Cancer Institute

Phone: 617-632-2166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Lacosamide n=18 participants at risk Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks	Placebo n=19 participants at risk Placebo orally twice a day.
Nervous system disorders headache	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Psychiatric disorders confusion	5.6% 1/18 • Number of events 1 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Psychiatric disorders hallucinations	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Nervous system disorders memory impairment	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
General disorders gait disturbance	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Infections and infestations lung infection	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms benign, malignant	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Skin and subcutaneous tissue disorders alopecia	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Investigations platelet count decreased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Investigations white blood cell count decreased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Investigations neutrophil count decreased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Gastrointestinal disorders oral hemorrhage	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Gastrointestinal disorders abdominal pain	5.6% 1/18 • Number of events 1 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Vascular disorders thromboembolic event	5.6% 1/18 • Number of events 1 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Metabolism and nutrition disorders dehydration	5.6% 1/18 • Number of events 1 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Injury, poisoning and procedural complications fall	5.6% 1/18 • Number of events 1 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Vascular disorders hypotension	5.6% 1/18 • Number of events 1 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Nervous system disorders lethargy	5.6% 1/18 • Number of events 1 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Nervous system disorders seizure	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Infections and infestations infection, possible sepsis	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.

Measure	Lacosamide n=18 participants at risk Lacosamide orally twice a day, starting dose 50 mg with dose escalation (increased by 100 mg/day weekly) until target dose 200 mg achieved over 4 weeks	Placebo n=19 participants at risk Placebo orally twice a day.
Investigations platelet count decreased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 6 • Adverse event data collected for up to one year treatment period.
Investigations white blood cell decreased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 8 • Adverse event data collected for up to one year treatment period.
Investigations alanine aminiotransferase increased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Investigations blood bilirubin increased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 4 • Adverse event data collected for up to one year treatment period.
Investigations neutrophil count decreased	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 4 • Adverse event data collected for up to one year treatment period.
Musculoskeletal and connective tissue disorders muscle weakness, left-sided	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	15.8% 3/19 • Number of events 3 • Adverse event data collected for up to one year treatment period.
Musculoskeletal and connective tissue disorders muscle weakness, right-sided	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 3 • Adverse event data collected for up to one year treatment period.
Eye disorders eye disorders, other	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Gastrointestinal disorders constipation	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Gastrointestinal disorders gastroesophageal reflux disease	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Gastrointestinal disorders gastrointestinal disorders, other	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
General disorders fatigue	11.1% 2/18 • Number of events 3 • Adverse event data collected for up to one year treatment period.	26.3% 5/19 • Number of events 5 • Adverse event data collected for up to one year treatment period.
General disorders gait disturbance	5.6% 1/18 • Number of events 2 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 4 • Adverse event data collected for up to one year treatment period.
Infections and infestations infections and infestations, other	11.1% 2/18 • Number of events 2 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms benigh, malignant and unspecified	5.6% 1/18 • Number of events 2 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.
Blood and lymphatic system disorders anemia	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Vascular disorders thromboembolic event	16.7% 3/18 • Number of events 3 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Vascular disorders hypertension	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 3 • Adverse event data collected for up to one year treatment period.
Surgical and medical procedures surgical and medical procedures	22.2% 4/18 • Number of events 6 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Skin and subcutaneous tissue disorders alopecia	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Nervous system disorders dyspnea	11.1% 2/18 • Number of events 2 • Adverse event data collected for up to one year treatment period.	0.00% 0/19 • Adverse event data collected for up to one year treatment period.
Nervous system disorders dysphasia	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Nervous system disorders headache	22.2% 4/18 • Number of events 4 • Adverse event data collected for up to one year treatment period.	26.3% 5/19 • Number of events 5 • Adverse event data collected for up to one year treatment period.
Nervous system disorders memory impairment	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	10.5% 2/19 • Number of events 2 • Adverse event data collected for up to one year treatment period.
Nervous system disorders seizure	0.00% 0/18 • Adverse event data collected for up to one year treatment period.	5.3% 1/19 • Number of events 1 • Adverse event data collected for up to one year treatment period.