FibromyalgiaNCT00254657
Levetiracetam for Treatment of Pain Associated With Fibromyalgia
A study testing Levetiracetam in people with Fibromyalgia, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of levetiracetam in reducing the pain of fibromyalgia when compared to placebo. Levetiracetam, an anti-seizure drug, is currently FDA-approved and marketed for use in patients with seizures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Apr 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age or older.
- Subjects must meet the 1990 American College of Rheumatology Criteria for the diagnosis of Fibromyalgia Syndrome.
- Subjects at screening must have an average score of at least 40mm on the Visual Analog Scale (VAS) of the SF-McGill Pain Questionnaire; and at baseline must have an average score of at least 4/10 over the last 7 days on the Daily Pain Rating Scale.
- Subjects must complete at least 4 diaries during the 7 days prior to randomization.
- Subjects must discontinue use of steroids, muscle relaxants, anticonvulsants, sodium channel blockers, topical analgesics, and needle-based therapies, including trigger point injections and acupuncture, at least 1 week prior to starting study medication and agree to stay off such therapies throughout the study. Continuation of nonsteroidal anti-inflammatories, antidepressants and opiates are allowed, provided they have reached a stable dose prior to study entry and maintain a stable dose throughout the study.
- Ability to understand and follow the instructions of the investigator, including completion of the study diaries as described in the protocol.
- Ability to provide informed written consent.
Who cannot join
- Subjects who have demonstrated a hypersensitivity to levetiracetam or who have been previously treated with it.
- Subjects with severe liver or kidney insufficiency (AST, ALT, BUN, Creatinine more than twice the upper limit of the reference range).
- Abnormal Westergen erythrocyte sedimentation rate (e.g. ESR >40 mm/min)
- Abnormal antinuclear antibody (ANA≥1:160), or rheumatoid factor (RF>80 IU/ml)
- Subjects with significant hematological disease, such as clotting disorders.
- Subjects who have undergone trigger point injections or other needle-based therapies in the two weeks prior to dosing.
Show all 13Show fewer
- Subjects having other severe pain that may confound assessment of the pain due to the fibromyalgia.
- Subjects taking or having taken any other experimental drugs, drugs not approved in the United States, or participating in or having participated in other clinical studies in the 2 months prior to this clinical trial.
- Subjects who have a history of illicit drug or alcohol abuse within the last year.
- Pregnant or lactating women.
- Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators
- Subjects who have serious or unstable medical or psychological conditions that in the opinion of the investigator(s), would compromise the subject's participation in the study.
- Subjects involved in any unsettled litigation such as automobile accident, civil lawsuit, or worker's compensation pertaining to their fibromyalgia, current involvement in out-of-court settlements for litigation pertinent to their fibromyalgia, or are currently receiving monetary compensation as a result of any of the above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia
The purpose of this study is to assess the safety and effectiveness of levetiracetam in reducing the pain of fibromyalgia when compared to placebo. Levetiracetam, an anti-seizure drug, is currently FDA-approved and marketed for use in patients with seizures. Levetiracetam may relieve pain by reducing abnormal activity in the nervous system. A placebo is an inactive substance.
Read the detailed description
The UCSF Pain Clinical Research Center (PCRC) will be conducting this investigator-initiated 9-week, randomized, double-blind, placebo-controlled, parallel group study of Levetiracetam. There will be a total of 6 study visits. Visit 1 is a screening visit to assess subject eligibility, followed by a one-week period of baseline daily pain and sleep assessments. Visit 2 (one week after Visit 1) subjects will be randomized in a 3/2-randomization scheme and administered study medication. Subjects randomized to the treatment group will start Levetiracetam at 1 tablet of 500/mg/day, and will titrate by 500mg each week to a maximum dose of 3000 mg/day. Visits 3, 4, 5, and 6 (occurring 2, 4, 6 and 8 weeks after started study drug) include safety and efficacy assessments. Study drug taper is initiated at Visit 6.
- Conditions
- Fibromyalgia
- Being tested
- Levetiracetam, Placebo
- Keywords
- Fibromyalgia, Fibro, Keppra, Levetiracetam
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
Started with one 500 mg tablet/day and titrated upward as tolerated over 6 weeks by 500 mg/week to a maximum dose of 3000 mg/day.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Levetiracetam | Experimental | Not described Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly mean of average daily pain score as recorded in subjects' daily pain diaries and measured on an 11-point Likert scale with endpoints 0 ("no pain") and 10 ("worst pain")
Measured: Baseline to final week of treatment
Secondary outcomes (7)
Sleep Interference over the past 24 hours as recorded in daily sleep diary on 11-point Likert scale (0 = "pain does not interfere with sleep" to 10 = "pain completely interferes with sleep"
Change from mean score during baseline week to mean score during final week of treatment before tapering period began
Measured: Baseline to final week of treatment
Fibromyalgia Impact Questionnaire
10-item, self-administered instrument designed to assess impact of fibromyalgia on physical functioning, work, fatigue, stiffness, anxiety and depression
Measured: Baseline to final week of treatment
Fibromyalgia Pain Now as measured using handheld 0-100 mm pain VAS (0 mm = "No pain" and 100 mm = "Worst pain imaginable"
Measured: Baseline to final week of treatment
Short-Form McGill Pain Questionnaire (SF-MPQ)
Part 1: Fibromyalgia pain severity over past 7 days rate on 0-100 mm VAS; Part 2: Present pain intensity - 6 item category rating of pain "right now"; Part 3: Fifteen pain descriptors rated over past 7 days using 4 point intensity score (0= none to 3 = severe) and summed into sensory score and affective score
Measured: Baseline to final week of treatment
Fibromyalgia tender point score
Number of days with headache in past 2 weeks reported (0=no headache; 1=1-2 days; 2=3-5 days; 3=6-9 days; 4=10-13 days; 5=headache all 14 days) and average headache severity rated on 0-10 NRS
Measured: Baseline to final week of treatment
Patient and Clinician Global Impression of Change
Impression of change rated independently by subject and clinician on 1-7 category scale (1="very much improved", 2="much improved", 3="improved", 4="no change", 5="worse", 6="much worse", 7="very much worse"
Measured: Final week of treatment
Fibromyalgia tender point score
Manual Tender Point Survey with each site rated on 0-10 scale (0="no pain" and 10="worst pain imaginable"); "Fibromyalgia intensity score" represents mean sensitivity of 18 standardized tender point sites and "Control intensity score" represents mean sensitivity of 3 control sites
Measured: Baseline to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Investigators
- Michael C Rowbotham, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254657
- Sponsor's protocol ID
- H5612-23162
- Status last verified
- May 2013
- First submitted
- 15 Nov 2005
- Last updated
- 13 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Levetiracetam for Treatment of Pain Associated With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00254657
- Acronym / sponsor ID
- H5612-23162
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Fibro, Keppra, Levetiracetam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Mar 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 16 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of levetiracetam in reducing the pain of fibromyalgia when compared to placebo. Levetiracetam, an anti-seizure drug, is currently FDA-approved and marketed for use in patients with seizures. Levetiracetam may relieve pain by reducing abnormal activity in the nervous system. A placebo is an inactive substance.
Detailed description
The UCSF Pain Clinical Research Center (PCRC) will be conducting this investigator-initiated 9-week, randomized, double-blind, placebo-controlled, parallel group study of Levetiracetam. There will be a total of 6 study visits. Visit 1 is a screening visit to assess subject eligibility, followed by a one-week period of baseline daily pain and sleep assessments. Visit 2 (one week after Visit 1) subjects will be randomized in a 3/2-randomization scheme and administered study medication. Subjects randomized to the treatment group will start Levetiracetam at 1 tablet of 500/mg/day, and will titrate by 500mg each week to a maximum dose of 3000 mg/day. Visits 3, 4, 5, and 6 (occurring 2, 4, 6 and 8 weeks after started study drug) include safety and efficacy assessments. Study drug taper is initiated at Visit 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Levetiracetam | Experimental | Drug: Levetiracetam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 18 years of age or older.
- Subjects must meet the 1990 American College of Rheumatology Criteria for the diagnosis of Fibromyalgia Syndrome.
- Subjects at screening must have an average score of at least 40mm on the Visual Analog Scale (VAS) of the SF-McGill Pain Questionnaire; and at baseline must have an average score of at least 4/10 over the last 7 days on the Daily Pain Rating Scale.
- Subjects must complete at least 4 diaries during the 7 days prior to randomization.
- Subjects must discontinue use of steroids, muscle relaxants, anticonvulsants, sodium channel blockers, topical analgesics, and needle-based therapies, including trigger point injections and acupuncture, at least 1 week prior to starting study medication and agree to stay off such therapies throughout the study. Continuation of nonsteroidal anti-inflammatories, antidepressants and opiates are allowed, provided they have reached a stable dose prior to study entry and maintain a stable dose throughout the study.
Key exclusion criteria (13 listed)
- Subjects who have demonstrated a hypersensitivity to levetiracetam or who have been previously treated with it.
- Subjects with severe liver or kidney insufficiency (AST, ALT, BUN, Creatinine more than twice the upper limit of the reference range).
- Abnormal Westergen erythrocyte sedimentation rate (e.g. ESR >40 mm/min)
- Abnormal antinuclear antibody (ANA≥1:160), or rheumatoid factor (RF>80 IU/ml)
- Subjects with significant hematological disease, such as clotting disorders.
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 |
|---|---|---|
| LevetiracetamAlso: KeppraStarted with one 500 mg tablet/day and titrated upward as tolerated over 6 weeks by 500 mg/week to a maximum dose of 3000 mg/day. | Drug | Levetiracetam |
| Placebo | Drug | Placebo |
Primary outcome
Weekly mean of average daily pain score as recorded in subjects' daily pain diaries and measured on an 11-point Likert scale with endpoints 0 ("no pain") and 10 ("worst pain")
Time frame: Baseline to final week of treatment
7 secondary outcomes
Sleep Interference over the past 24 hours as recorded in daily sleep diary on 11-point Likert scale (0 = "pain does not interfere with sleep" to 10 = "pain completely interferes with sleep"
Time frame: Baseline to final week of treatment
Fibromyalgia Impact Questionnaire
Time frame: Baseline to final week of treatment
Fibromyalgia Pain Now as measured using handheld 0-100 mm pain VAS (0 mm = "No pain" and 100 mm = "Worst pain imaginable"
Time frame: Baseline to final week of treatment
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Baseline to final week of treatment
Fibromyalgia tender point score
Time frame: Baseline to final week of treatment
Patient and Clinician Global Impression of Change
Time frame: Final week of treatment
Fibromyalgia tender point score
Time frame: Baseline to end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia 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.
Michael C Rowbotham, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam in people with Fibromyalgia, run by University of California, San Francisco at 1 site 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 7 inclusion and 13 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 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weekly mean of average daily pain score as recorded in subjects' daily pain diaries and measured on an 11-point Likert scale with endpoints 0 ("no pain") and 10 ("worst pain") (time frame: Baseline to final week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2013.