FibromyalgiaPhase 2NCT00366535

Neurotropin Treatment of Fibromyalgia

A Phase 2 study testing Neurotropin in people with Fibromyalgia, run by National Institute of Nursing Research (NINR) at 1 site 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 study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Fibromyalgia
What is being tested?: Neurotropin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited States
Study dates: Aug 2006to Dec 2015
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects will be drawn from a cohort of well-characterized female fibromyalgia patients who were under the care of Dr. Daniel. J. Clauw when he was at Georgetown University. All patients must continue to meet the criteria established by the ACR for diagnosis of fibromyalgia, and must have been treated unsuccessfully with a current standard therapeutic regimen. The criteria are (A) a history of widespread pain (in all quadrants and back) for more than half of the days in each of the prior three months and (B) the required number,11, of tender points of 18 test sites (indicated in Figure 1), which will be determined during the initial physical examination (see below). They must give informed consent to participate in this study. It is anticipated that almost all patients will be residents of Washington, D.C. area and that they will be able to travel to NIH for necessary preliminary studies and subsequent required evaluations. To be admitted to this study, patients must be willing to continue using only their present medications (including antidepressants) or other forms of care related to the control of fibromyalgia symptoms during the course of the study. The average score on the FIQ for patients seen in tertiary care settings is about 50 (with 100 being the maximum, a higher score indicating a greater impairment of health) and we will include only those patients in whom the FIQ score is greater than 30 at the initial evaluation.

Who cannot join

Pregnant and lactating women are excluded because of the bodily changes that would occur during the study. As indicated above, a pregnancy test will be performed in women of childbearing age (up to age 55). The combination of widespread musculoskeletal pain, high tender point count, and non-restorative sleep are usually sufficient criteria for the diagnosis of fibromyalgia and the patients referred for this study will have been well characterized in the Fibromyalgia Clinic at Georgetown University or by the referring physician. We will, however, by history, physical examination, screening laboratory studies and examination of the patient s medical records confirm the absence of any evidence for peripheral neuropathies, entrapment syndromes, neurologic disorders or metabolic/endocrine disorders, such as untreated hypothyroidism, as well as the rheumatoid disorders that might be confused with fibromyalgia and confound the study. Patients who have abnormal screening test results or who have traumatic or non-traumatic disorders to which pain may be attributed. Also, patients who have a positive HIV result will be excluded. Subjects with obviously impaired mental capacity that precludes informed consent and ability to provide adequate self-ratings are to be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be eligible for this study. Patients must have a history of widespread pain for more than half of the days in each of the three months before they enter the study. Candidates are screened with a medical history, physical examination, blood and urine tests, questionnaires and an electrocardiogram (EKG).

Participants take their usual medications for fibromyalgia in addition to either neurotropin or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain and level of physical capability. After 12 weeks, study subjects "cross-over" their medication; that is, patients who took neurotropin for the first 12 weeks of the study take placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return for evaluation.

Participants have blood and urine tests six times during the study and complete questionnaires each week about their pain, symptoms, and activities.

Read the detailed description

Fibromyalgia is a relatively common disorder, which occurs predominantly in women, that is characterized by widespread aching and stiffness in muscles. Although there have been numerous studies of fibromyalgia, its etiology has remained unclear, but it is generally believed that central pain processing abnormalities are involved. Neurotropin, a non-protein extract of inflamed cutaneous tissue from rabbits inoculated with vaccinia virus, has been used extensively in Japan for many years to treat a variety of chronic painful conditions, including fibromyalgia. This present protocol is a double blind, placebo-controlled, crossover study designed to examine the clinical efficacy of Neurotropin in treating women (neither pregnant nor lactating) suffering from fibromyalgia without evidence of any other cause of their complaint of pain. Patients must meet the American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia and must agree to maintain a stable therapeutic regimen throughout the 25-week study.

Conditions: Fibromyalgia
Being tested: Placebo, Neurotropin
Keywords: Muscle Pain, Fibrositis Allodynia, Stiffness, Tender Points, Fibromyalgia
Medical subject headings: Fibromyalgia, Myalgia

What participants receive

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

PlaceboDrug
Also called Drug A
4 tabs b.i.d.
NeurotropinDrug
Also called Drug B
4 tabs b.i.d.

Study groups in NCT00366535
Study group	Role	What they receive
Placebo first, then Neurotropin (G-1)	Active comparator	Double blind cross-over study: receive Placebo for 12 weeks and then Neurotropin for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind. Receives: Drug: Placebo; Drug: Neurotropin
Neurotropin first, then Placebo (G-2)	Active comparator	Double blind cross-over study: receive Neurotropin for 12 weeks and then Placebo for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others Receives: Drug: Placebo; Drug: Neurotropin

What is being measured

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

Fibromyalgia Impact Questionnaire
The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item self-administered measure to assess 3 areas of fibromyalgia (FM): function, overall impact, and symptoms. The total FIQ score was the primary outcome of the study. The total FIQ score is the sum of the 3 areas measured in the FIQ. The maximum possible total FIQ score is 100, with a minimum score of 10. The average FM patient scores about 50, severely afflicted FM patients are usually 70 and above. Data analysis is ongoing from data collected from study completers.
Measured: 25 weeks

Timeline

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

Aug 2006Dec 2015

First posted21 Aug 2006 (estimated)
Study startAug 2006
Primary completionDec 2015
Study completionDec 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 (3)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00366535
Sponsor's protocol ID: 060229
Other IDs: NCT00366535, 06-NR-0229
Status last verified: May 2018
First submitted: 18 Aug 2006
Last updated: 27 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
Individual data sharing: Undecided

Publications

Dworkin RH, Fields HL. Fibromyalgia from the perspective of neuropathic pain. J Rheumatol Suppl. 2005 Aug;75:1-5. No abstract available.
PubMed 16078355
Rowbotham MC. Is fibromyalgia a neuropathic pain syndrome? J Rheumatol Suppl. 2005 Aug;75:38-40.
PubMed 16078359
Crofford LJ. The relationship of fibromyalgia to neuropathic pain syndromes. J Rheumatol Suppl. 2005 Aug;75:41-5.
PubMed 16078360

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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Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurotropin Treatment of Fibromyalgia
ClinicalTrials.gov ID: NCT00366535
Acronym / sponsor ID: 060229
Conditions: Fibromyalgia
Keywords: Muscle Pain, Fibrositis Allodynia, Stiffness, Tender Points, Fibromyalgia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: National Institute of Nursing Research (NINR)US National Institutes of Health
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health Clinical Center (CC), University of Michigan, National Cancer Institute (NCI)
Study start: Aug 2006
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 21 Aug 2006 (estimated)
Results: Posted 4 Jun 2018

Clinical summary

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

Participants have blood and urine tests six times during the study and complete questionnaires each week about their pain, symptoms, and activities.

Detailed description

Study design

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

Arm	Type	Receives
Placebo first, then Neurotropin (G-1)	Active comparator	Drug: Placebo, Drug: NeurotropinDouble blind cross-over study: receive Placebo for 12 weeks and then Neurotropin for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind.
Neurotropin first, then Placebo (G-2)	Active comparator	Drug: Placebo, Drug: NeurotropinDouble blind cross-over study: receive Neurotropin for 12 weeks and then Placebo for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects will be drawn from a cohort of well-characterized female fibromyalgia patients who were under the care of Dr. Daniel. J. Clauw when he was at Georgetown University. All patients must continue to meet the criteria established by the ACR for diagnosis of fibromyalgia, and must have been treated unsuccessfully with a current standard therapeutic regimen. The criteria are (A) a history of widespread pain (in all quadrants and back) for more than half of the days in each of the prior three months and (B) the required number,11, of tender points of 18 test sites (indicated in Figure 1), which will be determined during the initial physical examination (see below). They must give informed consent to participate in this study. It is anticipated that almost all patients will be residents of Washington, D.C. area and that they will be able to travel to NIH for necessary preliminary studies and subsequent required evaluations. To be admitted to this study, patients must be willing to continue using only their present medications (including antidepressants) or other forms of care related to the control of fibromyalgia symptoms during the course of the study. The average score on the FIQ for patients seen in tertiary care settings is about 50 (with 100 being the maximum, a higher score indicating a greater impairment of health) and we will include only those patients in whom the FIQ score is greater than 30 at the initial evaluation.

Key exclusion criteria (1 listed)

Pregnant and lactating women are excluded because of the bodily changes that would occur during the study. As indicated above, a pregnancy test will be performed in women of childbearing age (up to age 55). The combination of widespread musculoskeletal pain, high tender point count, and non-restorative sleep are usually sufficient criteria for the diagnosis of fibromyalgia and the patients referred for this study will have been well characterized in the Fibromyalgia Clinic at Georgetown University or by the referring physician. We will, however, by history, physical examination, screening laboratory studies and examination of the patient s medical records confirm the absence of any evidence for peripheral neuropathies, entrapment syndromes, neurologic disorders or metabolic/endocrine disorders, such as untreated hypothyroidism, as well as the rheumatoid disorders that might be confused with fibromyalgia and confound the study. Patients who have abnormal screening test results or who have traumatic or non-traumatic disorders to which pain may be attributed. Also, patients who have a positive HIV result will be excluded. Subjects with obviously impaired mental capacity that precludes informed consent and ability to provide adequate self-ratings are to be excluded.

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
PlaceboAlso: Drug A4 tabs b.i.d.	Drug	Neurotropin first, then Placebo (G-2), Placebo first, then Neurotropin (G-1)
NeurotropinAlso: Drug B4 tabs b.i.d.	Drug	Neurotropin first, then Placebo (G-2), Placebo first, then Neurotropin (G-1)

Primary outcome

Fibromyalgia Impact Questionnaire
Time frame: 25 weeks
The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item self-administered measure to assess 3 areas of fibromyalgia (FM): function, overall impact, and symptoms. The total FIQ score was the primary outcome of the study. The total FIQ score is the sum of the 3 areas measured in the FIQ. The maximum possible total FIQ score is 100, with a minimum score of 10. The average FM patient scores about 50, severely afflicted FM patients are usually 70 and above. Data analysis is ongoing from data collected from study completers.

Results and safety

Results posted to the registry on 4 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Drug A Then Study Drug B (G-1)	27	24
Study Drug B First, Then Study Drug A (G-2)	29	21

Primary outcome: Fibromyalgia Impact Questionnaire

Time frame: 25 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	FIQ Before Placebo Treatment First in G-1 n = 20	FIQ After Placebo Treatment First in G-1 n = 20	FIQ Before Neurotropin Treatment Second in G-1 n = 20	FIQ After Neurotropin Treatment Second in G-1 n = 20	FIQ Before Neurotropin Treatment First in G-2 n = 16	FIQ After Neurotropin Treatment First in G-2 n = 16	FIQ Before Placebo Treatment Second in G-2 n = 16	FIQ After Placebo Treatment Second in G-2 n = 16
Value	49.9 (1.8)	37.5 (3.7)	39.9 (3.4)	33.4 (4.1)	47.7 (2.1)	28.8 (4.5)	30.1 (4.1)	32.8 (3.6)

Population analysed: Total 56 patients enrolled, and 39 patients completed the study. 17 patients withdrawn from the study. Three of 39 patients were excluded from the data analysis because there had missing FIQ scores at Baseline and/or Week 12. The data from the study of the 36 participants with complete data sets was analyzed.

Adverse events

Time frame: The adverse event data was collected during the study period for 6 to 7 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Treatment First in G-1	0 of 56 (0%)	3 of 56 (5.4%)	0 of 56
Neurotropin Treatment Second in G-1	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
Neurotropin Treatment First in G-2	0 of 27 (0%)	3 of 27 (11.1%)	0 of 27
Placebo Treatment Second in G-2	0 of 27 (0%)	1 of 27 (3.7%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16078355Dworkin RH, Fields HL. Fibromyalgia from the perspective of neuropathic pain. J Rheumatol Suppl. 2005 Aug;75:1-5. No abstract available.
Background: PubMed 16078359Rowbotham MC. Is fibromyalgia a neuropathic pain syndrome? J Rheumatol Suppl. 2005 Aug;75:38-40.
Background: PubMed 16078360Crofford LJ. The relationship of fibromyalgia to neuropathic pain syndromes. J Rheumatol Suppl. 2005 Aug;75:41-5.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Fibromyalgia

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Enrolling by invitationPhase 3
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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.

Leorey N Saligan, C.R.N.P. principal investigator

National Institute of Nursing Research (NINR)

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neurotropin in people with Fibromyalgia, run by National Institute of Nursing Research (NINR) 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 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 27 Jun 2018. 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. 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 4 Jun 2018). 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?

Fibromyalgia Impact Questionnaire (time frame: 25 weeks). 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 NCT00366535, which also lists 3 linked publications.

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 27 Jun 2018.