MigrainePhase 4TOGETHERNCT05492695
Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study
A Phase 4 study testing Galcanezumab in people with Migraine, run by Diamond Headache Clinic at 1 site in United States.
Trial summary
This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Galcanezumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 28 Sep 2023
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate and sign informed consent;
- Ability to understand informed consent and study procedures, including ability to use the electronic Daily Headache Diary;
- In good general health based on investigator's judgment;
- Must be between 18 to 65 years of age, inclusive, at time of Visit 1;
- Reports having an average of > 6 migraine days per month, after at least 2 and up to 8 consecutive treatments of onabotulinumtoxinA at the time of screening, meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-3);
- Subject reports a > 30% decrease in the number of monthly migraine days from the onset of treatment with Botox (onabotulinumtoxinA);
Show all 13Show fewer
- Has a score on the Migraine Disability Assessment Questionnaire (MIDAS) >11 at screening;
- During the baseline period reports >6 migraine days per month and < 25 days of head pain;
- Onset of migraine before age 50;
- Able to differentiate migraine from other primary headache types allowed in the study (e.g., tension-type headache);
- Agrees to present for screening 28 days (± 3 days) prior to next anticipated Botox treatment, and to continue BMPT documented at screening for the rest of the study period. Subjects unwilling or unable to continue BMPT will not proceed through the study.;
- Women may be included only if they have a negative pregnancy test at screening and baseline, are sterile, or postmenopausal. Women of childbearing potential (WOCBP) whose male partners are potentially fertile (i.e., no vasectomy) must use highly effective birth control methods for the duration of the study (i.e., starting at screening). Definitions of WOCBP, sterile and postmenopausal women, male contraception, and highly effective and acceptable birth control methods are to be determined based on investigator's judgment;
- Demonstrated > 85% compliance the electronic Daily Headache Diary during 28-day run-in period (as defined as data entry on a minimum of 24 of the first 28 days of run-in period).
Who cannot join
- Unable to understand the study requirements, the informed consent, or complete headache diaries as required per protocol;
- Pregnant, actively trying to become pregnant, or breast-feeding;
- Reports daily head pain during the month prior to screening;
- Relevant history of substance abuse and/or dependence, in the opinion of the investigator;
- History of impaired renal function that, in the investigator's opinion, contraindicates participation in this study;
- Suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events;
Show all 33Show fewer
- A psychiatric condition, in the opinion of the investigator, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study;
- Received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
- Exposure to biologics targeting the CGRP pathway in the previous 6 months or 5 half-lives, whichever is longer, or reports treatment with > 8 doses of small molecules targeting the CGRP pathway for acute abortive therapy in the last 30 days any CGRP blocker utilized for prevention of migraine is excluded from participation;
- Has failed more than 3 classes of the following medications for the prevention of migraine due to a lack of efficacy (defined as no meaningful reduction in frequency of migraine days after an adequate trial of at least 2 months at generally accepted therapeutic doses), or >6 migraine preventative medications of any type, based on investigator's judgement
- Propranolol, metoprolol, atenolol, bisoprolol, timolol, or nadolol
- Topiramate
- Flunarizine
- Valproate or divalproex
- Amitriptyline or nortriptyline
- Venlafaxine or desvenlafaxine
- Lisinopril
- Candesartan
- Received any investigational agents within 30 days prior to Visit 1;
- Plans to participate in another clinical study at any time during this study;
- History of medication overuse of opioids or butalbital (as defined by use ≥10 days per month) in previous 12 months or during run-in period; MOH (as defined by ICHD-3) with other medication types will be allowed but must be documented;
- Use of more than 1 other medication, in addition to onabotulinumtoxinA for the prevention of migraine 12 weeks prior to screening or throughout the study;
- Experienced a change in any concomitant migraine therapies in the12 weeks prior to screening or any non-migraine therapies which could confound assessment of response to IP in the opinion of the investigator;
- Has a history of hyper-sensitivity reaction to any monoclonal antibody therapy or any component of galcanezumab injections;
- Clinically relevant lab abnormalities at screening as determined by the investigator;
- Clinically relevant or significant ECG abnormalities, including but not limited to ECG with QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) > 500 msec; in the investigators opinion.
- History of any of the following cardiovascular conditions:
- Moderate to severe congestive heart failure (New York Heart Association class III or IV);
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting;
- Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
- Active HIV or Hepatitis C infection;
- Score of > 0 on question 9 of the Patient Health Questionnaire (PHQ-9) at any visit;
- Have any other condition, in the judgment of the investigator, would make the participant unsuitable for inclusion, or would interfere with the participant participating in or completing the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study
This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.
- Conditions
- Migraine
- Being tested
- Galcanezumab, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalcanezumabDrug
Galcanezumab is a calcitonin-gene related peptide antagonist indicated in adults for the preventive treatment of migraine and the treatment of episodic cluster headache.
PlaceboOther
Galcanezumab' placebo. This is the same vehicle as the study intervention formulation but does not contain active galcanezumab-gnlm.
| Study group | Role | What they receive |
|---|---|---|
| Galcanezumab + BMPT | Active comparator | * 240 mg of galcanezumab will be administered once as a loading dose at Visit 2, followed by monthly doses of 120 mg at Visits 3 and 4.
* All participants will be required to continue BMPT. For consistency purposes visit 2/ randomization should be scheduled within +/- 3 days of subjects next Botox administration as part of BMPT. Receives: Drug: Galcanezumab |
| Placebo + BMPT | Placebo comparator | • Galcanezumab matching placebo will be administered at Visits 2, 3 and 4. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monthly Migraine Days
Measured: Baseline to Treatment Month 3
Secondary outcomes (8)
Change in Monthly Migraine days
Measured: Baseline to Treatment Months 1, 2, & 3
Change in Monthly Headache days
Measured: Baseline to Treatment Months 1, 2, & 3
Change in PROMIS Pain Interference scores
Measured: Baseline to Treatment Months 1, 2, & 3
Change in Functional Assessment of Migraine Scale - Research (FAMS-R) scores
Measured: Baseline to Treatment Months 1, 2, & 3
Change in Functional Assessment of Migraine Scale - Research Supplement (FAMS-RS) scores
Measured: Baseline to Treatment Months 1, 2, & 3
Change in Migraine Disability Assessment (MIDAS) scores
Measured: Baseline to Treatment Months 1, 2, & 3
Frequency of 50% Responders
50% Responders is defined as at least 50% reduction in number of monthly migraine days compared to baseline
Measured: Baseline to Treatment Months 1, 2, & 3
Monthly Acute Migraine Medication use
Measured: Baseline to Treatment Months 1, 2, & 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Oct 2022
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Why it stopped: Stopped from financial sponsor due to inability to enroll participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamond Headache Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher P Rhyne, MD, Study director, Diamond Headache Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492695
- Sponsor's protocol ID
- 5Q-US-X003
- Acronym
- TOGETHER
- Status last verified
- Sep 2023
- First submitted
- 5 Aug 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study
- ClinicalTrials.gov ID
- NCT05492695
- Acronym / sponsor ID
- TOGETHER / 5Q-US-X003
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped from financial sponsor due to inability to enroll participants.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Diamond Headache ClinicUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- 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.
This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galcanezumab + BMPT | Active comparator | Drug: Galcanezumab* 240 mg of galcanezumab will be administered once as a loading dose at Visit 2, followed by monthly doses of 120 mg at Visits 3 and 4. * All participants will be required to continue BMPT. For consistency purposes visit 2/ randomization should be scheduled within +/- 3 days of subjects next Botox administration as part of BMPT. |
| Placebo + BMPT | Placebo comparator | Other: Placebo• Galcanezumab matching placebo will be administered at Visits 2, 3 and 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing to participate and sign informed consent;
- Ability to understand informed consent and study procedures, including ability to use the electronic Daily Headache Diary;
- In good general health based on investigator's judgment;
- Must be between 18 to 65 years of age, inclusive, at time of Visit 1;
- Reports having an average of > 6 migraine days per month, after at least 2 and up to 8 consecutive treatments of onabotulinumtoxinA at the time of screening, meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-3);
Key exclusion criteria (33 listed)
- Unable to understand the study requirements, the informed consent, or complete headache diaries as required per protocol;
- Pregnant, actively trying to become pregnant, or breast-feeding;
- Reports daily head pain during the month prior to screening;
- Relevant history of substance abuse and/or dependence, in the opinion of the investigator;
- History of impaired renal function that, in the investigator's opinion, contraindicates participation in this study;
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 |
|---|---|---|
| GalcanezumabGalcanezumab is a calcitonin-gene related peptide antagonist indicated in adults for the preventive treatment of migraine and the treatment of episodic cluster headache. | Drug | Galcanezumab + BMPT |
| PlaceboGalcanezumab' placebo. This is the same vehicle as the study intervention formulation but does not contain active galcanezumab-gnlm. | Other | Placebo + BMPT |
Primary outcome
Change in Monthly Migraine Days
Time frame: Baseline to Treatment Month 3
8 secondary outcomes
Change in Monthly Migraine days
Time frame: Baseline to Treatment Months 1, 2, & 3
Change in Monthly Headache days
Time frame: Baseline to Treatment Months 1, 2, & 3
Change in PROMIS Pain Interference scores
Time frame: Baseline to Treatment Months 1, 2, & 3
Change in Functional Assessment of Migraine Scale - Research (FAMS-R) scores
Time frame: Baseline to Treatment Months 1, 2, & 3
Change in Functional Assessment of Migraine Scale - Research Supplement (FAMS-RS) scores
Time frame: Baseline to Treatment Months 1, 2, & 3
Change in Migraine Disability Assessment (MIDAS) scores
Time frame: Baseline to Treatment Months 1, 2, & 3
Frequency of 50% Responders
Time frame: Baseline to Treatment Months 1, 2, & 3
Monthly Acute Migraine Medication use
Time frame: Baseline to Treatment Months 1, 2, & 3
Results and safety
The study was stopped early (reason given: Stopped from financial sponsor due to inability to enroll participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Christopher P Rhyne, MD study director
Diamond Headache Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Galcanezumab in people with Migraine, run by Diamond Headache Clinic 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 13 inclusion and 33 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 29 Sep 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Stopped from financial sponsor due to inability to enroll participants.). 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 Monthly Migraine Days (time frame: Baseline to Treatment Month 3). 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 29 Sep 2023.