Trial Outcomes & Findings for A Study to Test the Use of Duloxetine for Pain in MS (NCT NCT00457730)

NCT ID: NCT00457730

Last Updated: 2015-04-27

Results Overview

Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 38 participants
• Primary outcome timeframe: at week 6
• Results posted on: 2015-04-27

Participant Flow

Participant milestones

Measure	Duloxetine subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo	Placebo subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
Overall Study STARTED	18	20
Overall Study COMPLETED	14	19
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Test the Use of Duloxetine for Pain in MS

Baseline characteristics by cohort

Measure	Duloxetine n=18 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo	Placebo n=20 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo	Total n=38 Participants Total of all reporting groups
Age, Continuous	54.71 years STANDARD_DEVIATION 9.97 • n=5 Participants	56.33 years STANDARD_DEVIATION 11.23 • n=7 Participants	56.3 years STANDARD_DEVIATION 9.97 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: at week 6

Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.

Outcome measures

Measure	Duloxetine n=14 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo	Placebo n=18 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo
Percent Change in Worst Pain Score	-29.1 percent reduction on 0-10 analog scale Standard Deviation 20.4	-11.5 percent reduction on 0-10 analog scale Standard Deviation 18.2

SECONDARY outcome

Timeframe: at week 6

Percent change in Weekly mean of 24 hour Average pain Score, Week 6 vs. baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.

Outcome measures

Measure	Duloxetine n=14 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo	Placebo n=18 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo
Percent Change in Average Pain Score.	-38.5 percent reduction on 0-10 analog scale Standard Deviation 29.1	-10.4 percent reduction on 0-10 analog scale Standard Deviation 18.85

SECONDARY outcome

Timeframe: Week 6 vs baseline

global impression: "How do you feel about the effects of the medication over the past 7 days? 7 point scale, 7 = delighted, 1= terrible

Outcome measures

Measure	Duloxetine n=13 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo	Placebo n=18 Participants subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg. Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions. Placebo: Subjects are randomized to either Duloxetine or Placebo
Global Impression of Change	4.77 units on a scale Standard Deviation 1.3	3.94 units on a scale Standard Deviation 1.16

Adverse Events

Duloxetine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Duloxetine n=18 participants at risk Study drug, Duloxetine, 30 mg for 1 week, titrate up to 60 mg for 5 weeks and titrate back down to 30 mg for 1 week.	Placebo n=20 participants at risk Placebo: Matching placebo drug for 7 weeks total
Gastrointestinal disorders nausea	11.1% 2/18 • Number of events 2	0.00% 0/20
Nervous system disorders headache	11.1% 2/18 • Number of events 2	10.0% 2/20 • Number of events 2
Nervous system disorders dizziness	11.1% 2/18 • Number of events 2	0.00% 0/20

Additional Information

Theodore R. Brown, MD Principle Investigator

MS Center at Evergreenhealth Care

Phone: 425-899-5350

Email: trbrown@evergreenhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place