Fibromyalgia SyndromePhase 2NCT00401830

Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

A Phase 2 study testing Lacosamide in people with Fibromyalgia Syndrome, run by UCB Pharma at 25 sites in United States.

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

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia Syndrome
What is being tested?: Lacosamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: 25 sitesUnited States
Study dates: Oct 2006to Feb 2008
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females, 18 to 65 years old
Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Who cannot join

Symptomatic regional or structural rheumatic disease
Diagnosed neuropathic pain syndrome
Receiving treatment with neurostimulating devices
Significant psychopathology
History of chronic alcohol or drug abuse within 6 months prior to Screening
Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening

Show all 9Show fewer

Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias
Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)
Other medical conditions that could compromise the subject's ability to participate in the study

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Study site
Athens, Georgia
Study site
Brockton, Massachusetts, 20301
Study site
Charlotte, North Carolina, 28210
Study site
Columbia, Maryland, 21045
Study site
Decatur, Georgia, 30033
Study site
Deerfield Beach, Florida, 33064
Study site
Evansville, Indiana, 47714
Study site
Fort Lauderdale, Florida, 33334
Study site
Fort Myers, Florida, 33916
Study site
Frederick, Maryland, 21702
Study site
Goose Creek, South Carolina, 29445
Study site
Kirkland, Washington, 98033
Study site
Litchfield Park, Arizona
Study site
Madisonville, Kentucky, 42431
Study site
Memphis, Tennessee, 30033
Study site
Mogadore, Ohio, 44260
Study site
Peoria, Illinois, 61614
Study site
Richmond, Virginia, 23294
Study site
San Antonio, Texas, 78213
Study site
San Antonio, Texas
Study site
Santa Ana, California, 92705
Study site
Tampa, Florida, 33614
Study site
Toledo, Ohio, 43623
Study site
Walnut Creek, California, 94598
Study site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Read the detailed description

This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Conditions: Fibromyalgia Syndrome
Being tested: Lacosamide, Placebo
Keywords: Fibromyalgia Syndrome, Lacosamide, Vimpat, Harkoseride
Medical subject headings: Fibromyalgia

What participants receive

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

LacosamideDrug
Also called Vimpat, Harkoseride
Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg
PlaceboOther
Matching placebo tablet administered twice daily

Study groups in NCT00401830
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Other: Placebo
Lacosamide	Experimental	Lacosamide Tablet 400mg daily Receives: Drug: Lacosamide

What is being measured

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

Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Measured: Baseline, Last 2 weeks of the 12-week Treatment Phase
Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Measured: Baseline, Last 2 weeks of the 12-week Treatment Phase

Secondary outcomes (12)

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
Measured: Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
Measured: Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
Measured: Baseline, Last 2 weeks of the 12-week Treatment Phase
Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
Measured: Baseline, Last 2 weeks of the 12-week Treatment Phase
Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Measured: Baseline, Last 2 weeks of the 12 week Treatment Phase
Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Measured: Baseline, Last 2 weeks of the 12 week Treatment Phase
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
Measured: Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.
Measured: Baseline, Last assessment in the 12-week Treatment Phase
Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase
Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.
Measured: 12-week Treatment Phase
Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase
Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).
Measured: 12-week Treatment Phase
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
Measured: Baseline, Last assessment in the 12-week Treatment Phase
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Measured: End of the Maintenance Phase/Week 12

Timeline

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

Oct 2006Feb 2008

First posted22 Nov 2006 (estimated)
Study startOct 2006
Primary completionFeb 2008
Study completionFeb 2008

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.
Other trials for Fibromyalgia SyndromeStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00401830
Sponsor's protocol ID: SP0887
Status last verified: Jul 2017
First submitted: 9 Nov 2006
Last updated: 18 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

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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All Fibromyalgia Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
ClinicalTrials.gov ID: NCT00401830
Acronym / sponsor ID: SP0887
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndrome, Lacosamide, Vimpat, Harkoseride
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 22 Oct 2009

Clinical summary

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

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Detailed description

This was a proof-of-concept study and not powered for statistical comparisons.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo
Lacosamide	Experimental	Drug: LacosamideLacosamide Tablet 400mg daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or females, 18 to 65 years old
Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase

Key exclusion criteria (9 listed)

Symptomatic regional or structural rheumatic disease
Diagnosed neuropathic pain syndrome
Receiving treatment with neurostimulating devices
Significant psychopathology
History of chronic alcohol or drug abuse within 6 months prior to Screening

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
LacosamideAlso: Vimpat, HarkoserideTablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg	Drug	Lacosamide
PlaceboMatching placebo tablet administered twice daily	Other	Placebo

Primary outcome

Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

12 secondary outcomes

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Time frame: Baseline, Last 2 weeks of the 12 week Treatment Phase
Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Time frame: Baseline, Last 2 weeks of the 12 week Treatment Phase
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase
Time frame: 12-week Treatment Phase
Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase
Time frame: 12-week Treatment Phase
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Time frame: End of the Maintenance Phase/Week 12

Results and safety

Results posted to the registry on 22 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	81	50
Lacosamide	78	46

Primary outcome: Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)

Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase. Mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo n = 80	Lacosamide n = 78
Value	-1.30 (1.92)	-1.80 (2.13)

Population analysed: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

Primary outcome: Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)

Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase. Mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo n = 36	Lacosamide n = 41
Value	-2.11 (1.98)	-2.40 (2.08)

Population analysed: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 81 (3.7%)	37 of 81 (45.7%)	Not reported
Lacosamide	0 of 78 (0%)	53 of 78 (67.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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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.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lacosamide in people with Fibromyalgia Syndrome, run by UCB Pharma at 25 sites in United States.

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 5 inclusion and 9 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Oct 2009). 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 Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set) (time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase). The study lists 2 primary outcomes in all. 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 NCT00401830.

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 18 Jul 2018.