The primary objective is to evaluate the safety and tolerability of perampanel (up to12mg/day) given as adjunctive treatment in subjects with refractory partial seizuresThe secondary objective is to evaluate the maintenance of effect of perampanel…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For subjects who were assigned to the perampanel treatment arms during the
preceding double-blind studies, the following variables will be analyzed over
the Double-blind Phase plus the Open-label Treatment Phase (Conversion Period +
Maintenance Period) relative to Pre-randomization Phase of the double-blind
study. For subjects who were assigned to the placebo arms during the
double-blind studies, the following variables will only be analyzed over the
Open-label Treatment Phase (Conversion Period + Maintenance Period) relative to
Pre-randomization Phase of the double-blind study:
1. Percent change in seizure frequency per 28 days
2. Proportion of patient who experience a 50% or greater reduction in seizure
frequency per 28 days (responder rate analysis)
3. Percent change in seizure frequency per 28 days per seizure type
Secondary outcome
The safety will be examined based on nature, frequency, and severity of adverse
events, chemistry and hematology laboratory test results, vital signs, and
12-lead ECG abnormalities over the perampanel treatment period
Background summary
Epilepsy is a common, serious neurological disorder. Epilepsy is characterized
by the spontaneous recurrence of seizures and requires long-term, often
life-long, pharmacological treatment. In general there are 2 types of seizures
and the most frequent type is partial seizures. Patients suffering from partial
seizures often have poor seizure control. This leads to a wide variety of
medical consequences (e.g., severe trauma due to the seizure, sudden death,
depression, psychotic disorders). In addition, uncontrolled seizures have a
large impact on the lifestyle and lead to social handicaps (e.g., loss of
driving privileges and difficulties getting and/or maintaining a job).
Over the past 15 years, several new anti-epileptic drugs have appeared on the
market with the objective of improving efficacy, tolerability and ease use when
compared with the classical anti-epileptic drugs. Although the medications are
efficacious and relatively safe, they do not meet the treatment needs of
patients with epilepsy among other things apparently due the following:
- In over 30% of the patients the seizures are poorly controlled with current
treatment
- 25% of the patients starting with a certain anti-epileptic drug have to
abandon treatment as a result of serious side effects and a much higher number
suffer from chronic side effects that will limit their quality of life
- various epilepsy syndromes appear completely resistant to standard therapies.
From the above, the need for the development of new anti-epileptic drugs with
improved efficacy and tolerability is needed.
Study objective
The primary objective is to evaluate the safety and tolerability of perampanel
(up to12mg/day) given as adjunctive treatment in subjects with refractory
partial seizures
The secondary objective is to evaluate the maintenance of effect of perampanel
for the control of refractory partial seizures.
Study design
open-label extension study
Intervention
The study can be divided in 2 parts:
A conversion period:
All patients will take during this period once a day 6 tablets. These tablets
consists of 2 mg perampanel tablets and/or placebo tablets. The patients will
start with the dose that they received in the preceding study (except those
that received placebo, they will start with 2 mg) and this dose will be
up-titrated every 2 weeks with 2 mg until the optimal dose is reached.
B Maintenance period:
The patient will take 2 mg and/or 4mg tablets
Study burden and risks
Extent of burden:
Patients are asked to visit the research location 10 times in a period of 14
months.
Patients are asked to keep a diary about the frequency of seizures and the
number of side effects.
Between every visit there will be a telephone contact, to remind the patient to
keep the diary etc.
Women of childbearing potential must agree to be abstinent or continue using at
least 1 medically acceptable method of contraception throughout the entire
study periode and for 2 months after the last dose of study drug.
In addition the following assessments will take place:
3 x complete physical exam
3 x complete neurological exam
10 x vital signs (pulse and blood pressure)
10 x determine body weight (at screening also length)
5 x ECG
5 x blood draw
Risks:
Risks on side effects:
Neurological side effects: sleepiness; dizziness; sedation; vertigo; tingling
in nerves; and difficulty moving; difficulty walking; abnormal movements; and
other worsening of the symptoms of known Parkinson's disease.
Gastro-intestinal side effects: abdominal pain; vomiting; constipation;
diarrhoea.
Other side effects: falls; insomnia; an increase in blood pressure; fatigue;
increased rigidity in joints; muscle cramps; depression; and itching of the
skin.
Risks of drawing blood:
May cause local pain, bruising, bleeding, blood clot formation, and, in rare
instances, an infection might occur at the site where blood is drawn. There is
also the possibility of dizziness or fainting while your blood is being drawn.
55 Challenger Road
Ridgefield Park, NJ 07660
US
55 Challenger Road
Ridgefield Park, NJ 07660
US
Listed location countries
Age
Inclusion criteria
- Have completed visit 8 of study E2007-G000-304, E2007-G000-305 or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (exluding criteria that are related to seizure occurences)
- Continue to be treated with a stable dose of 1 or maximum of 3 approved AEDs
Exclusion criteria
- Those who, for any reason, discontinued early from the preceding double-blind study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-006170-28-NL |
| CCMO | NL23258.040.08 |