Fibromyalgia PainPhase 1NCT03029845
Propranolol for Treating Fibromyalgia Pain
A Phase 1 study testing Propranolol 1 and Propranolol 2 in people with Fibromyalgia Pain, run by University of Utah at 1 site in United States.
Trial summary
The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia Pain
- What is being tested?
- Propranolol 1 and Propranolol 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jul 2018
- Phase
- Phase 1
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with fibromyalgia (both meeting 1990 American College of Rheumatology (ACR) FMS criteria and 2010 ACR FMS criteria) age 18-65 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week).
Who cannot join
- General Health Criteria:
- Uncontrolled/unstable illnesses (physician diagnosed, self-report)
- Pregnancy or planning to be pregnant in the next year
- Having Asthma requiring medication treatment including inhaler
- Type I diabetes or Type II diabetes requiring medical therapy that can lead to hypoglycemia
- Having acute pain or neuropathic pain
Show all 30Show fewer
- Participation in exercise or psychological treatment studies in the past 2 years
- Having known serious psychopathology: Psychosis, history of inpatient psychiatric admission in the past year, active suicidal intent, history of self-injurious behaviors in the past year, history of recreational IV drug use, substance abuse history in the past year)
- Cardiovascular Criteria:
- Having known cardiovascular diseases (self-report, physician diagnosed)
- Pacemaker
- Bradycardia (resting heartrate of less than 55 bpm)
- Resting diastolic BP < 55 mmHG or systolic BP<100 mmHG
- ECG showing prolonged PR interval > .2 sec
- ECG showing irregular PR interval
- ECG showing incongruence between P wave and QRS
- Medication Criteria
- Allergy or intolerance of beta blockers
- Current use of the following drugs:
- Antihypertensive drugs
- Neuroleptics
- Monoamine oxidase inhibitors
- Tizanidine
- Amphetamine-based medications
- Bupropion
- Mirtazapine
- Tricyclics: daily dose greater than 75mg amitriptyline or equivalent
- Benzodiazepine: daily dose greater than 5mg diazepam or equivalent
- Asthmatic medicine, including inhaler
- Participants may be included after minimum of 4 weeks of physician prescribed termination of these drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Propranolol for Treating Fibromyalgia Pain: Pilot Study
The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.
Read the detailed description
The main purpose of this study is to collect pilot feasibility study data for the use of low dose propranolol for helping treat fibromyalgia. The investigators plan to compare 20mg twice a day dosage of propranolol and 10mg twice a day dosage of propranolol to placebo. The design is a 3 arm, double blind randomized control trial. The investigators will also test ECG and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia.
Propranolol is not indicated to treat pain. However, the previous studies showed that low dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with chronic musculoskeletal pain. However, the investigators are not aiming to develop a new indication of the drug.
- Conditions
- Fibromyalgia Pain
- Being tested
- Propranolol 1, Propranolol 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol 1Drug
Also called 20 mg propranolol
Participants will take 20 mg propranolol twice a day for 2 weeks
Propranolol 2Drug
Also called 10 mg propranolol
Participants will take 10 mg propranolol twice a day for 2 weeks
PlaceboDrug
Participants will take placebo twice a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| propranolol 1 | Active comparator | 20 mg propranolol twice a day Receives: Drug: Propranolol 1 |
| propranolol 2 | Active comparator | 10 mg propranolol twice a day Receives: Drug: Propranolol 2 |
| Placebo | Placebo comparator | Placebo twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
Changes in clinical pain will be measured
Measured: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
Secondary outcomes (1)
Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue
Changes in fibromyalgia-related symptoms
Measured: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionApr 2018
- Study completionJul 2018
Why it stopped: The funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akiko Okifuji, University of Utah
- Investigators
- Akiko Okifuji, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029845
- Sponsor's protocol ID
- 00084875
- Status last verified
- Aug 2018
- First submitted
- 18 Jan 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol for Treating Fibromyalgia Pain: Pilot Study
- ClinicalTrials.gov ID
- NCT03029845
- Acronym / sponsor ID
- 00084875
- Conditions
- Fibromyalgia Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding ended.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 24 Jan 2017 (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 the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.
Detailed description
The main purpose of this study is to collect pilot feasibility study data for the use of low dose propranolol for helping treat fibromyalgia. The investigators plan to compare 20mg twice a day dosage of propranolol and 10mg twice a day dosage of propranolol to placebo. The design is a 3 arm, double blind randomized control trial. The investigators will also test ECG and respiratory assessment as a part of the safety screening and the feasible assessment of respiratory sinus arrhythmia.
Propranolol is not indicated to treat pain. However, the previous studies showed that low dose propranolol can re-regulate the adrenergic dysfunction and reduce pain in people with chronic musculoskeletal pain. However, the investigators are not aiming to develop a new indication of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propranolol 1 | Active comparator | Drug: Propranolol 120 mg propranolol twice a day |
| propranolol 2 | Active comparator | Drug: Propranolol 210 mg propranolol twice a day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females with fibromyalgia (both meeting 1990 American College of Rheumatology (ACR) FMS criteria and 2010 ACR FMS criteria) age 18-65 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week).
Key exclusion criteria (30 listed)
- General Health Criteria:
- Cardiovascular Criteria:
- Medication Criteria
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 |
|---|---|---|
| Propranolol 1Also: 20 mg propranololParticipants will take 20 mg propranolol twice a day for 2 weeks | Drug | propranolol 1 |
| Propranolol 2Also: 10 mg propranololParticipants will take 10 mg propranolol twice a day for 2 weeks | Drug | propranolol 2 |
| PlaceboParticipants will take placebo twice a day for 2 weeks | Drug | Placebo |
Primary outcome
Change in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R)
Time frame: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
Changes in clinical pain will be measured
1 secondary outcome
Change in self-reported measures of Fibromyalgia symptoms using Promis Fatigue
Time frame: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)
Results and safety
The study was stopped early (reason given: The funding ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Akiko Okifuji, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propranolol 1 and Propranolol 2 in people with Fibromyalgia Pain, run by University of Utah 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 30 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: stopped early, as of the sponsor's last update on 23 Aug 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The funding ended.). Results are not available in the source record.
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 in self-reported measures of clinical pain using Fibromyalgia Impact Questionnaire - Revised (FIQ-R) (time frame: Pre (one week before start taking propranolol or placebo) and Post (immediately following the 14-day trial)). 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 23 Aug 2018.