FibromyalgiaPhase 4NCT01020474

Adolescent Fibromyalgia Study

A Phase 4 study testing pregabalin (Lyrica) in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 36 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Fibromyalgia
What is being tested?: pregabalin (Lyrica)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 36 sitesin 4 countries
Study dates: May 2010to Dec 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of fibromyalgia
12-17 years of age

Who cannot join

Patients with other pain conditions
Previous treatment with pregabalin
Patients taking excluded medication

Trial locations and contacts

36 sites in 4 countries.

Country

City, postcode or hospital

36 sites in 4 countries

United States30 sites

Akron Children's Hospital
Akron, Ohio, 44308
Akron Children's Hospital
Boardman, Ohio, 44512
Boardman Medical Pavilion
Boardman, Ohio, 44512
Medical University of South Carolina, Pediatric Rheumatology
Charleston, South Carolina, 29425
Medical University of South Carolina
Charleston, South Carolina, 29425
MUSC University Children's Hospital
Charleston, South Carolina, 29425
University of Cincinnati
Cincinnati, Ohio, 45219
Medical Research & Health Education Foundation, Inc.
Columbus, Georgia, 31909
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
Eileen Messing, Psy D.
Delray Beach, Florida, 33446
Arthritis Associates of South Florida
Delray Beach, Florida, 33484
Delray Research Associates
Delray Beach, Florida, 33484
Duke University Medical Center
Durham, North Carolina, 27717
North Georgia Rheumatology, PC
Lawrenceville, Georgia, 30045
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202
Kosair Children's Hospital
Louisville, Kentucky, 40202
University of Louisville
Louisville, Kentucky, 40202
University Pediatric Rheumatology of Kentucky, LLC
Louisville, Kentucky, 40202
Florida Medical Center and Research, Inc.
Miami, Florida, 33142
Carolina Research Center
Myrtle Beach, South Carolina, 29572
Harmony Clinical Research, Incorporated
North Miami Beach, Florida, 33162
Rheumatology Associates of Central Florida, PA
Orlando, Florida, 32806
St. Christopher's Hospital for Children / Section of Rheumatology
Philadelphia, Pennsylvania, 19134-1095
Duke Medicine Plaza
Raleigh, North Carolina, 27609
Fatigue Consultation Clinic
Salt Lake City, Utah, 84102
Apex Research Institute
Santa Ana, California, 92705
A&A Pain Institute of St. Louis
St Louis, Missouri, 63141
University of Massachusetts Memorial Medical Center Department of Pediatrics
Worcester, Massachusetts, 01655

Other trials in United States

India4 sites

Department of Physical Medicine & Rehabilitation
Lucknow, Uttar Pradesh, 226 018
Mallikatta Neuro Centre
Mangalore, Karnataka, 575002
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Nagpur, Maharashtra, 440010
Krishna Institute of Medical Sciences Ltd
Secunderabad, Andhra Pradesh, 500 003

Other trials in India

Czechia1 site

Bioregeneracni a rehabilitacni centrum
Říčany, 25101

Other trials in Czechia

Taiwan1 site

National Taiwan University Hospital
Taipei, 100

Other trials in Taiwan

About this study

Official title: A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia

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.

Conditions: Fibromyalgia
Being tested: placebo, pregabalin (Lyrica)
Keywords: juvenile primary fibromyalgia syndrome, pediatric fibromyalgia, pregabalin, and Lyrica
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
matching placebo capsules twice daily.
pregabalin (Lyrica)Drug
75-450mg/day pregabalin dose optimised at start of study

Study groups in NCT01020474
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: placebo
drug-pregabalin	Experimental	Not described Receives: Drug: pregabalin (Lyrica)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 15 in Mean Pain Diary Score
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").
Measured: Week 15

Secondary outcomes (7)

Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
Measured: Week 15
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline to Week 15
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
Measured: Baseline to Week 15
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.
Measured: Week 15
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Week 15
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Week 15
Proportion of Patient Global Impression Change (PGIC) at Week 15
Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Dec 2014

First posted25 Nov 2009 (estimated)
Study startMay 2010
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01020474
Sponsor's protocol ID: A0081180
Other IDs: 2010-019521-34
Status last verified: Jun 2015
First submitted: 23 Nov 2009
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4.
PubMed 27475753

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruiting
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Fibromyalgia
Enrolling by invitation
Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation
Arthritis, Fibromyalgia
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia
ClinicalTrials.gov ID: NCT01020474
Acronym / sponsor ID: A0081180
Conditions: Fibromyalgia
Keywords: juvenile primary fibromyalgia syndrome, pediatric fibromyalgia, pregabalin, and Lyrica
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 25 Nov 2009 (estimated)
Results: Posted 25 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placebo
drug-pregabalin	Experimental	Drug: pregabalin (Lyrica)

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Diagnosis of fibromyalgia
12-17 years of age

Key exclusion criteria (3 listed)

Patients with other pain conditions
Previous treatment with pregabalin
Patients taking excluded medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
placebomatching placebo capsules twice daily.	Drug	Placebo
pregabalin (Lyrica)75-450mg/day pregabalin dose optimised at start of study	Drug	drug-pregabalin

Primary outcome

Change From Baseline to Week 15 in Mean Pain Diary Score
Time frame: Week 15
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").

7 secondary outcomes

Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Time frame: Week 15
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Time frame: Baseline to Week 15
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Time frame: Baseline to Week 15
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
Time frame: Week 15
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
Time frame: Week 15
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
Time frame: Week 15
Proportion of Patient Global Impression Change (PGIC) at Week 15
Time frame: Week 15

Results and safety

Results posted to the registry on 25 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	54	44
Placebo	53	36

Primary outcome: Change From Baseline to Week 15 in Mean Pain Diary Score

Time frame: Week 15. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Pregabalin n = 54	Placebo n = 51
Value	-1.60 (0.32)	-0.94 (0.31)

Pregabalin vs Placebo: Mean Difference (Final Values): -0.66 (95% CI -1.51 to 0.18), p = 0.121, ANCOVA

Population analysed: The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	1 of 54 (1.9%)	33 of 54 (61.1%)	Not reported
Placebo	0 of 53 (0%)	27 of 53 (50.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27475753Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Fibromyalgia

Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruiting
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Fibromyalgia
Enrolling by invitation
Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation
Arthritis, Fibromyalgia
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

36 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pregabalin (Lyrica) in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 36 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, India, Czechia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 15 in Mean Pain Diary Score (time frame: Week 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01020474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021; AzTrials last refreshed its copy on 28 Oct 2026.