FibromyalgiaPhase 4NCT01020526

Pregabalin In Adolescent Patients With Fibromyalgia

A Phase 4 study testing pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 26 sites in 3 countries.

Completed

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

Official record

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Trial summary

The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin Read more about this study

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Fibromyalgia
What is being tested?: pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 26 sitesin 3 countries
Study dates: Sep 2010to Jun 2015
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 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

Who cannot join

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.

Trial locations and contacts

26 sites in 3 countries.

Country

City, postcode or hospital

26 sites in 3 countries

United States21 sites

Akron Children's Hospital
Akron, Ohio, 44308
Akron Children's Hospital-Mahoning Valley
Boardman, Ohio, 44512
Akron Children's Hospital
Boardman, Ohio, 44512
Medical University of South Carolina, Pediatric Rheumatology
Charleston, South Carolina, 29425
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
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
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 & Research
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
Fatigue Consultation Clinic
Salt Lake City, Utah, 84102
Apex Research Institute
Santa Ana, California, 92705
University of Massachusetts Memorial Medical Center Department of Pediatrics
Worcester, Massachusetts, 01655

Other trials in United States

India4 sites

King George's Medical University
Lucknow, Uttar Pradesh, 226 018
Mallikatta Neuro Center
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

About this study

Official title: A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia

Conditions: Fibromyalgia
Being tested: pregabalin
Medical subject headings: Fibromyalgia

What participants receive

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

pregabalinDrug
Oral capsule 75-450 mg/day

Study groups in NCT01020526
Study group	Role	What they receive
Pregabalin	Experimental	Not described Receives: Drug: pregabalin

What is being measured

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

Change From Baseline in Pain Numeric Rating Scale by Week
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 worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.
Measured: Baseline, Weeks 3, 8, 16, 24 and Last Visit.

Timeline

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

Sep 2010Jun 2015

First posted25 Nov 2009 (estimated)
Study startSep 2010
Primary completionJun 2015
Study completionJun 2015

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: Non-randomised
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01020526
Sponsor's protocol ID: A0081231
Other IDs: 2010-020300-29
Status last verified: May 2016
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

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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 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT01020526
Acronym / sponsor ID: A0081231
Conditions: Fibromyalgia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 25 Nov 2009 (estimated)
Results: Posted 1 Jul 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pregabalin	Experimental	Drug: pregabalin

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

Key exclusion criteria (1 listed)

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.

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
pregabalinOral capsule 75-450 mg/day	Drug	Pregabalin

Primary outcome

Change From Baseline in Pain Numeric Rating Scale by Week
Time frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit.
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 worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.

Results and safety

Results posted to the registry on 1 Jul 2016, 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	63	49

Primary outcome: Change From Baseline in Pain Numeric Rating Scale by Week

Time frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit.. Mean (Standard Deviation). Unit: Number

Measure	Pregabalin n = 63
Baseline (N=63)	6.7 (1.68)
Week 3 (N=61)	-2.1 (2.51)
Week 8 (N=55)	-1.8 (2.95)
Week 16 (N=51)	-2.1 (2.6)
Week 24 (N=55)	-2.1 (2.56)
Last Visit (N=63)	-2.1 (2.47)

Population analysed: This population will include all participants who have received at least one dose of study medication.

Adverse events

Time frame: Adverse Events were recorded from the time the participants had taken at least one dose of study drug through the last subject visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	3 of 63 (4.8%)	32 of 63 (50.8%)	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
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Recruiting
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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

26 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 26 sites in 3 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 1 inclusion and 1 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 26 sites in United States, India, Czechia. 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. 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 1 Jul 2016). 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 in Pain Numeric Rating Scale by Week (time frame: Baseline, Weeks 3, 8, 16, 24 and Last Visit.). 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 NCT01020526, 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.