Trial Outcomes & Findings for Cyclobenzaprine Extended Release (ER) for Fibromyalgia (NCT NCT01041495)

Results Overview

Visual Analogue Pain Scale -Change in baseline subjective pain based on a 10 point scale (1= no pain, 10 = severe pain) from baseline (T=Zero, prior to drug/placebo treatment) to week 8. Higher scores are worse

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-11-27

Participant Flow

radio and billboard ads were used to recruit subjects who were then screened a a psychiatric based practice

subjects had to meet eligibility criteria

Participant milestones

Participant milestones
Measure	Cyclobenzaprine ER active muscle relaxant medication	Placebo matching placebo
Overall Study STARTED	16	12
Overall Study COMPLETED	12	5
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cyclobenzaprine ER active muscle relaxant medication	Placebo matching placebo
Overall Study Withdrawal by Subject	2	5
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Cyclobenzaprine Extended Release (ER) for Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclobenzaprine ER n=16 Participants	Placebo n=12 Participants	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants	12 Participants n=107 Participants	28 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	15 Participants n=99 Participants	10 Participants n=107 Participants	25 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	16 participants n=99 Participants	12 participants n=107 Participants	28 participants n=206 Participants

PRIMARY outcome

Timeframe: 8 weeks

Visual Analogue Pain Scale -Change in baseline subjective pain based on a 10 point scale (1= no pain, 10 = severe pain) from baseline (T=Zero, prior to drug/placebo treatment) to week 8. Higher scores are worse

Outcome measures

Outcome measures
Measure	Cyclobenzaprine ER n=16 Participants cyclobenzaprine ER (AMRIX): active drug	Placebo n=12 Participants placebo: matching placebo for AMRIX
Visual Analogue Pain Scale at 8 Weeks Post Treatment	4.8 units on a scale Interval 4.0 to 6.0	5.7 units on a scale Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: baseline to 8 weeks

Brief Fatigue Inventory- Change in baseline subjective fatigue based on this scale (1= no fatigue, 10 = severe fatigue) from baseline (T=Zero, prior to drug/placebo treatment) to week 8 where higher scores are worse

Outcome measures

Outcome measures
Measure	Cyclobenzaprine ER n=16 Participants cyclobenzaprine ER (AMRIX): active drug	Placebo n=12 Participants placebo: matching placebo for AMRIX
Brief Fatigue Inventory at 8 Weeks Post Treatment	4.7 score on a scale Interval 4.0 to 6.0	4.8 score on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: from baseline to 8 weeks

Change in baseline subjective fibromyalgia symptoms based on a 100 point scale (0 = no fibromyalgia or minimum score, 100 = severe fibromyalgia and maximal score) from baseline (T=Zero, prior to drug/placebo treatment) to week 8

Outcome measures

Outcome measures
Measure	Cyclobenzaprine ER n=16 Participants cyclobenzaprine ER (AMRIX): active drug	Placebo n=12 Participants placebo: matching placebo for AMRIX
Fibromyalgia Impact Questionnaire Scores at 8 Weeks Post Treatment	59 units on a scale Interval 36.0 to 59.0	51 units on a scale Interval 40.0 to 51.0

Adverse Events

Cyclobenzaprine ER

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cyclobenzaprine ER n=16 participants at risk active drug	Placebo n=12 participants at risk inactive placebo matching
Endocrine disorders glucosemia	0.00% 0/16 • During acute study (8 Weeks)	8.3% 1/12 • During acute study (8 Weeks)
General disorders Fatigue	6.2% 1/16 • During acute study (8 Weeks)	0.00% 0/12 • During acute study (8 Weeks)
General disorders dizziness	6.2% 1/16 • During acute study (8 Weeks)	0.00% 0/12 • During acute study (8 Weeks)

Additional Information

thomas schwartz

SUNY Upstate MEdical Univ

Phone: 3154643166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place