Trial Outcomes & Findings for Efficacy of Gralise® for Chronic Pelvic Pain (NCT NCT01678911)

Results Overview

The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

4 Visits over a 15 week period

Results posted on

2015-06-29

Participant Flow

11 Subjects enrolled in the study and started a single-blind placebo lead-in period. Of those, 5 were randomized. 6 subjects did not continue and were either lost to follow-up, chose not to continue, or exhibited a large placebo response and no longer met the criteria to continue in the study.

Participant milestones

Participant milestones
Measure	Placebo, Then Gralise Subjects may receive a pill with no medicine.	Gralise Then Placebo Gralise (a long acting gabapentinoid) Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of "wash-out" before repeating the above procedure for the other arm of the study (placebo or medication).
First Intervention STARTED	4	1
First Intervention Cross Over	4	1
First Intervention COMPLETED	4	1
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	4	1
Second Intervention COMPLETED	2	1
Second Intervention NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Then Gralise Subjects may receive a pill with no medicine.	Gralise Then Placebo Gralise (a long acting gabapentinoid) Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of "wash-out" before repeating the above procedure for the other arm of the study (placebo or medication).
Second Intervention Lost to Follow-up	2	0

Baseline Characteristics

Efficacy of Gralise® for Chronic Pelvic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=5 Participants All randomized subjects
Age, Continuous	44.6 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Visits over a 15 week period

The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).

Outcome measures

Outcome measures
Measure	Placebo Then Gralise n=4 Participants Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.	Gralise Then Placebo n=1 Participants Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
McGill Pain Questionnaire - Short Form change from baseline after intervention 1	-0.34 units on a scale Standard Deviation 1.78	.04 units on a scale Standard Deviation 0
McGill Pain Questionnaire - Short Form change from baseline after intervention 2	1.05 units on a scale Standard Deviation 0.45	.41 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 4 Visits over an 8 week period

The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.

Outcome measures

Outcome measures
Measure	Placebo Then Gralise n=4 Participants Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.	Gralise Then Placebo n=1 Participants Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
Pain Anxiety Symptoms Scale mean change after intervention 1	-5.8 units on the PASS scale Standard Deviation 18.0	-4 units on the PASS scale Standard Deviation 0
Pain Anxiety Symptoms Scale mean change after intervention 2	9.0 units on the PASS scale Standard Deviation 22.6	-5 units on the PASS scale Standard Deviation 0

SECONDARY outcome

Timeframe: 4 visits over an 8 week period

The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.

Outcome measures

Outcome measures
Measure	Placebo Then Gralise n=4 Participants Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.	Gralise Then Placebo n=1 Participants Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
Pain Disability Index change after intervention 1	4.8 units on a scale Standard Deviation 13.9	10 units on a scale Standard Deviation 0
Pain Disability Index change after intervention 2	19 units on a scale Standard Deviation 4.2	14 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 4 visits over 15 week period

The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.

Outcome measures

Outcome measures
Measure	Placebo Then Gralise n=4 Participants Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.	Gralise Then Placebo n=1 Participants Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
Center for Epidemiologic Studies Depression Scale change after intervention 1	4.5 units on a scale Standard Deviation 5.7	-1 units on a scale Standard Deviation 0
Center for Epidemiologic Studies Depression Scale change after intervention 2	7 units on a scale Standard Deviation 2.8	0 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 4 Visits over 15 weeks

Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.

Outcome measures

Outcome measures
Measure	Placebo Then Gralise n=4 Participants Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.	Gralise Then Placebo n=1 Participants Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
Patient Global Impression of Change improved after intervention 1	3 participants	0 participants
Patient Global Impression of Change no change after intervention 1	0 participants	1 participants
Patient Global Impression of Change worse after intervention 1	1 participants	0 participants
Patient Global Impression of Change improved after intervention 2	1 participants	0 participants
Patient Global Impression of Change no change after intervention 2	1 participants	0 participants
Patient Global Impression of Change worse after intervention 2	0 participants	1 participants

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Gralise

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	Sugar Pill n=5 participants at risk Subjects may receive a pill with no medicine.	Gralise n=5 participants at risk Gralise (a long acting gabapentinoid) Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of "wash-out" before repeating the above procedure for the other arm of the study (placebo or medication).
General disorders Drowsiness	20.0% 1/5	40.0% 2/5

Additional Information

Director of the Center for Pain Studies

Rehabilitation Institute of Chicago

Phone: 312.238.5654

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place