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Anti-epileptic drug

drug-pregabalin for Fibromyalgia

Phase 4
Waitlist Available
Research Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 15
Awards & highlights

Summary

This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.

Eligible Conditions
  • Fibromyalgia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to Week 15 in Mean Pain Diary Score
Secondary study objectives
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
+4 more

Side effects data

From 2013 Phase 4 trial • 10 Patients • NCT01727791
60%
Dizziness
20%
Headache
10%
Back pain
10%
Restless legs syndrome
10%
Somnolence
10%
Muscular weakness
10%
Diarrhoea
10%
Dry mouth
10%
Nausea
10%
Vomiting
10%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pregabalin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: drug-pregabalinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin
FDA approved

Find a Location

Who is running the clinical trial?

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Lead Sponsor
434 Previous Clinical Trials
407,367 Total Patients Enrolled
18 Trials studying Fibromyalgia
11,088 Patients Enrolled for Fibromyalgia
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,524 Previous Clinical Trials
14,908,941 Total Patients Enrolled
26 Trials studying Fibromyalgia
13,667 Patients Enrolled for Fibromyalgia
~7 spots leftby Sep 2025
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