Fibromyalgia SyndromePhase 2SP888NCT00464737
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
A Phase 2 study testing Rotigotine in people with Fibromyalgia Syndrome, run by UCB Pharma at 35 sites in United States.
Trial summary
This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed. 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?
- Rotigotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 35 sitesUnited States
- Study dates
- Mar 2007to Nov 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
- Subject is male or female, 18 to 65 years of age (inclusive)
- Subject fulfills all 3 points of the American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia (pain, stiffness, and/or sleep disorder)
- Subject must complete an adequate washout period for excluded medications, as necessary, prior to beginning the Baseline Diary Phase
- Subject has at least moderate pain that is defined as an average pain intensity of ≥5 on an 11-point Likert pain scale (0-10) during the 7 days prior to Baseline
- Subject must have at least 5 morning and 5 evening Likert pain scale scores for the 7 days immediately prior to Visit 2 and the average daily pain score over these 7 days must be ≥5 (average daily pain score is determined as follows: calculate the mean of the morning and evening scores separately using all pain scores for the 7 days immediately prior to Visit 2; add the mean morning and evening scores and divide by 2)
- Subject has a score of ≥50 on Fibromyalgia Impact Questionnaire (FIQ), with a score of 100 representing severe disease at Baseline
Who cannot join
- Subject has symptomatic regional or structural rheumatic disease (eg, knee or hip osteoarthritis, bursitis, tendonitis), rheumatic autoimmune disease or inflammatory rheumatic disease, such as systemic lupus erythematosus (SLE), mild primary osteoarthritis of the hand(s) is allowed
- Subject has diagnosed neuropathic pain syndrome
- Subject has received therapy with a dopamine agonist (eg, pramipexole, ropinirole) for 3 months or longer that was not considered effective in managing fibromyalgia symptoms
- Subject is receiving disability or is involved in litigation related to fibromyalgia syndrome
- Subject has significant psychopathology as determined by the investigator based on results of the Structural Clinical Interview for DSM-IV Diagnosis (SCID-I). The SCID-I must be administered by a physician or clinical psychologist trained to administer the instrument
- Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (MIDI)
- Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial
- Subject has orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of ≥20 mmHg in systolic blood pressure (SBP) or of ≥10 mmHg in diastolic blood pressure (DBP) taken from the 5-minute supine value and the 1- and/or 3-minute standing measurements, or supine SBP <105 mmHg at Baseline
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Study site
Albuquerque, New Mexico
Study site
Bountiful, Utah
Study site
Charlotte, North Carolina
Study site
Cleveland, Ohio, 44122
Study site
Columbia, Maryland
Study site
Cromwell, Connecticut, 06416
Study site
Crossville, Tennessee
Study site
Dallas, Texas
Study site
Dayton, Ohio, 45408
Study site
DeLand, Florida, 32720
Study site
Fort Myers, Florida
Study site
Gainesville, Florida, 32611
Study site
Mesa, Arizona
Study site
Mobile, Alabama
Study site
New York, New York, 10022
Study site
Ocala, Florida
Study site
Oklahoma City, Oklahoma, 73112
Study site
Orlando, Florida, 32806
Study site
Palm Beach, Florida
Study site
Peoria, Arizona, 85381
Study site
Portland, Oregon
Study site
Raleigh, North Carolina, 27612
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
Santa Ana, California, 92705
Study site
Seattle, Washington, 98104
Study site
Souderton, Pennsylvania
Study site
Springfield, Massachusetts, 01103
Study site
St Louis, Missouri, 63141
Study site
Stratford, New Jersey
Study site
Sunrise, Florida
Study site
Tampa, Florida, 33606
Study site
Williamsville, New York
Study site
Woodstock, Vermont, 05091
About this study
Official title: A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 2 Different Doses of Rotigotine in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.
Read the detailed description
The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). 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
- Rotigotine, Placebo
- Keywords
- Fibromyalgia Syndrome, Rotigotine, Neupro
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotigotineDrug
Also called Neupro
Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch)
RotigotineDrug
Also called Neupro
Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches)
PlaceboOther
Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| Rotigotine 4 mg | Experimental | 4 mg/24 hrs Receives: Drug: Rotigotine |
| Rotigotine 8 mg | Experimental | 8 mg/24 hrs Receives: Drug: Rotigotine |
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
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 Morning and Evening Pain Scores 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
Number of Subjects Using Rescue Medication and Alcohol 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. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.
Measured: 12-week Treatment Phase
Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12
Measured: End of the Maintenance Phase/Week 12
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
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
Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase
The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.
Measured: Baseline, Last assessment in the 12-week Treatment Phase
Number of Subjects With Presence of Impulse Control Disorders
Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).
Measured: 12-week Treatment Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- Study completionNov 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464737
- Sponsor's protocol ID
- SP888
- Acronym
- SP888
- Status last verified
- Sep 2010
- First submitted
- 23 Apr 2007
- Last updated
- 22 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. 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 2 Different Doses of Rotigotine in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT00464737
- Acronym / sponsor ID
- SP888 / SP888
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndrome, Rotigotine, Neupro
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Apr 2007 (estimated)
- Results
- Posted 5 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.
Detailed description
The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| Rotigotine 4 mg | Experimental | Drug: Rotigotine4 mg/24 hrs |
| Rotigotine 8 mg | Experimental | Drug: Rotigotine8 mg/24 hrs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is male or female, 18 to 65 years of age (inclusive)
- Subject fulfills all 3 points of the American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia (pain, stiffness, and/or sleep disorder)
- Subject must complete an adequate washout period for excluded medications, as necessary, prior to beginning the Baseline Diary Phase
- Subject has at least moderate pain that is defined as an average pain intensity of ≥5 on an 11-point Likert pain scale (0-10) during the 7 days prior to Baseline
- Subject must have at least 5 morning and 5 evening Likert pain scale scores for the 7 days immediately prior to Visit 2 and the average daily pain score over these 7 days must be ≥5 (average daily pain score is determined as follows: calculate the mean of the morning and evening scores separately using all pain scores for the 7 days immediately prior to Visit 2; add the mean morning and evening scores and divide by 2)
Key exclusion criteria (8 listed)
- Subject has symptomatic regional or structural rheumatic disease (eg, knee or hip osteoarthritis, bursitis, tendonitis), rheumatic autoimmune disease or inflammatory rheumatic disease, such as systemic lupus erythematosus (SLE), mild primary osteoarthritis of the hand(s) is allowed
- Subject has diagnosed neuropathic pain syndrome
- Subject has received therapy with a dopamine agonist (eg, pramipexole, ropinirole) for 3 months or longer that was not considered effective in managing fibromyalgia symptoms
- Subject is receiving disability or is involved in litigation related to fibromyalgia syndrome
- Subject has significant psychopathology as determined by the investigator based on results of the Structural Clinical Interview for DSM-IV Diagnosis (SCID-I). The SCID-I must be administered by a physician or clinical psychologist trained to administer the instrument
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 |
|---|---|---|
| RotigotineAlso: NeuproTitration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch) | Drug | Rotigotine 4 mg |
| RotigotineAlso: NeuproTitration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches) | Drug | Rotigotine 8 mg |
| PlaceboTitration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches. | 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
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 Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase
Time frame: 12-week Treatment Phase
Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12
Time frame: End of the Maintenance Phase/Week 12
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
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
Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Number of Subjects With Presence of Impulse Control Disorders
Time frame: 12-week Treatment Phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- For Safety Alerts amd Recalls refer toLink 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)
35 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 Rotigotine in people with Fibromyalgia Syndrome, run by UCB Pharma at 35 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 6 inclusion and 8 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 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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 5 Jan 2010). 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?
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 22 Jun 2015.