Trial Outcomes & Findings for Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children (NCT NCT01675960)

Last Updated: 2019-08-02

Results Overview

We will determine whether gabapentin provides symptom relief for chronic irritability in neurologically impaired children, who continue to have irritability even though potential sources may have been identified and treated, or have sources that have not been identified.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Results posted on

2019-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Gabapentin, Then Placebo Participants first receive gabapentin 3 times per day, with varying dosing based on the protocol. After 34-38 days, a washout period of 3 days occurs, before then receiving the placebo dose for 32 days.	Placebo, Then Gabapentin Participants first receive placebo 3 times per day. After 34-38 days, a washout period of 3 days occurs, before then receiving Gabapentin, with varying dosing based on the protocol, for 32 days.
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gabapentin, Then Placebo n=2 Participants Participants first receive gabapentin 3 times per day, with varying dosing based on the protocol. After 34-38 days, a washout period of 3 days occurs, before then receiving the placebo dose for 32 days.	Placebo, Then Gabapentin Participants first receive placebo 3 times per day. After 34-38 days, a washout period of 3 days occurs, before then receiving Gabapentin, with varying dosing based on the protocol, for 32 days.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=93 Participants	—	2 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	—	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants	—	2 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Region of Enrollment United States	2 Participants n=93 Participants	—	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Population: No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).

Population: No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.

We will attempt to identify gastrointestinal and sleep problems in neurologically impaired children with questionnaires given throughout the study. We hypothesize that gastrointestinal symptoms (feeding intolerance and symptoms associated with gas and bowel movements) and disrupted sleep are frequently associated with chronic irritability and will improve with gabapentin.

Outcome measures

Outcome data not reported

Adverse Events

Gabapentin

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

Other adverse events
Measure	Gabapentin n=2 participants at risk Neurotin Gabapentin: The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.	Placebo n=2 participants at risk Glycerin based clear solution that is flavored similar to the commercial product placebo
General disorders Increased sleepiness	50.0% 1/2 • Number of events 1 • Adverse events were collected during each contact with the subject after initial drug administration. Patient contacts were scheduled at day 6, 13, 24, 28, 34-37, 38, 44, 51, 62, and 76. SAE still ongoing at end of study period will be followed up on to determine final outcome. Adverse events are collection on all participants who received at least one dose of intervention, regardless of arm.	0.00% 0/2 • Adverse events were collected during each contact with the subject after initial drug administration. Patient contacts were scheduled at day 6, 13, 24, 28, 34-37, 38, 44, 51, 62, and 76. SAE still ongoing at end of study period will be followed up on to determine final outcome. Adverse events are collection on all participants who received at least one dose of intervention, regardless of arm.

Additional Information

Scott Schwantes

Children's of Minnesota

Phone: (612)813-7888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place