Trial Outcomes & Findings for Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT (NCT NCT00566462)
NCT ID: NCT00566462
Last Updated: 2018-09-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2018-09-06
Participant Flow
Participant milestones
| Measure |
Perampanel
A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
|
Placebo
A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT
Baseline characteristics by cohort
| Measure |
Perampanel
n=1 Participants
A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
|
Placebo
A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
|
Total
n=1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: No data was collected because the study was terminated at the sponsor request due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4Population: No data was collected because the study was terminated at the sponsor request due to low enrollment.
Outcome measures
Outcome data not reported
Adverse Events
Perampanel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Perampanel
n=1 participants at risk
A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
|
Placebo
A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of perampanel-matched placebo for 14 days, then two 2-mg tablets/day (4-mg/day)PO of perampanel-matched placebo for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
100.0%
1/1
|
—
0/0
|
|
Nervous system disorders
Frontal Headache
|
100.0%
1/1
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Sore Tongue
|
100.0%
1/1
|
—
0/0
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER