Trial Outcomes & Findings for Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise) (NCT NCT01623271)

Results Overview

Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

At visit 3

Results posted on

2020-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	CRPS I Pain Subjects This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks. Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CRPS I Pain Subjects This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks. Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRPS I Pain Subjects n=5 Participants This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks. Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Visual Analog Scale (VAS)	5.8 units on a scale n=93 Participants

PRIMARY outcome

Timeframe: At visit 3

Population: Only 3 subjects completed visit 3. The other 2 subjects dropped out due to expected side effects.

Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3.

Outcome measures

Outcome measures
Measure	CRPS I Pain Subjects n=3 Participants This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks. Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
Visual Analog Scale (VAS) at Visit 3	3.67 units on the VAS Standard Deviation 1.15

Adverse Events

CRPS I Pain Subjects

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CRPS I Pain Subjects n=5 participants at risk This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks. Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day
General disorders Expected Side Effects of Gralise	40.0% 2/5 • Number of events 2

Additional Information

Jianren Mao, MD, PhD

Massachusetts General Hospital

Phone: 617-724-6102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place