Migraine With or Without AuraPhase 2ANODYNE-1NCT06245902
An Acute Migraine Factorial Study
A Phase 2 study testing Naltrexone and Acetaminophen, Naltrexone and Acetaminophen-High Dose and Naltrexone Alone (regular dose) in people with Migraine With or Without Aura, run by Allodynic Therapeutics, Inc at 1 site in United States.
Trial summary
The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine With or Without Aura
- What is being tested?
- Naltrexone and Acetaminophen, Naltrexone and Acetaminophen-High Dose and Naltrexone Alone (regular dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2017to 8 Feb 2018
- Phase
- Phase 2
- 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.
- History of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version) for at least one-year with first migraine prior to age 50.
- Migraine-associated nausea with ≥half of migraine attacks.
- 2 - 8 migraines per month in each of the previous 3 months.
- The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.
- The female patient who is premenopausal or postmenopausal less than 1 year, or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using adequate and reliable contraception throughout the study (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). The male patient must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after taking the study drug.
Who cannot join
- The patient in the opinion of the investigator, may have medication-overuse headache pain (as defined by ICHD - 3 beta criteria for medication-overuse headache), (analgesic, opioid, ergotamine or triptan overuse) during the 3 months preceding screening.
- The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine).
- History of cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
- Initiation or change in medications with possible migraine prophylactic effects during 3 months before inclusion into the trial (E.g., calcium channel blockers, tricyclic antidepressants, beta-blockers, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), or Botox).
- Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
- A history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
Show all 12Show fewer
- The Female patient is pregnant or breast-feeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose.
- Use of opiates or barbiturates more than 3 days per month.
- Known-hypersensitivity reaction to any of the components of the investigational drug.
- Consumption of analgesic medication for other conditions on a regular basis, (nonsteroidal anti-inflammatory drugs, or acetaminophen, or muscle relaxants).
- Use of emergency care treatment more than 3 times in the previous 6 months.
- Participation in another study with an investigational drug within 30 days prior to randomization and/or a plan to participate during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine
The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
- Conditions
- Migraine With or Without Aura
- Being tested
- Naltrexone and Acetaminophen, Naltrexone and Acetaminophen-High Dose, Naltrexone Alone (regular dose), Acetaminophen Alone, Matching Placebo
- Keywords
- Migraine Disorders
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone and AcetaminophenDrug
Naltrexone plus acetaminophen
Naltrexone and Acetaminophen-High DoseDrug
Naltrexon (high dose) plus acetaminophen
Naltrexone Alone (regular dose)Drug
Naltrexone Alone plus Placebo
Acetaminophen AloneDrug
Acetaminophen Alone plus Placebo
Matching PlaceboDrug
Two Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone and Acetaminophen | Experimental | Patients take one capsule containing naltrexone and one capsule containing acetaminophen together for a qualifying migraine Receives: Drug: Naltrexone and Acetaminophen |
| Naltrexon/Acetaminophen-High Capsules | Experimental | Patient take one capsule containing naltrexone (high dose) and one capsule containing acetaminophen together for a qualifying migraine Receives: Drug: Naltrexone and Acetaminophen-High Dose |
| Naltrexone Alone Capsules | Active comparator | Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine Receives: Drug: Naltrexone Alone (regular dose) |
| Acetaminophen Alone Capsules | Active comparator | Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine Receives: Drug: Acetaminophen Alone |
| Placebo Capsules | Placebo comparator | Patient take two capsule containing placebo together for a qualifying migraine Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients reporting no headache pain.
Self-reported headache pain on a four-point Likert scale.
Measured: 2 hours post-dose
% of patients having absence of most bothersome migraine-associated symptom (MBS).
MBS was prospectively identified at baseline. Self-reported MBS as present or absent.
Measured: 2 hours post-dose
% of patients who have "sustained pain freedom"
Defined as having no headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain within 24 hours after administration of the investigational drug.
Measured: 24-hour post-dose.
Secondary outcomes (3)
% of patients having absence of nausea, photophobia, phonophobia, and neck/shoulder pain
Self-reported the current status of their associated symptom as present or absent.
Measured: 24-hour post-dose.
% of patients who used rescue medications
Measured: 2-24 hours
% of patients who had headache pain relapse.
Defined as the return of headache of any severity within 48 hours after administration of the investigational drug, when the patient was pain-free at 2 hours after the administration of the investigational drug.
Measured: 2-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start18 Feb 2017
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Migraine With or Without AuraStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allodynic Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annette C Toledano, M.D., Study director, Allodynic Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245902
- Sponsor's protocol ID
- ANODYNE-1 Version 1.3
- Acronym
- ANODYNE-1
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Zhang Y, Peng Y, Hutchinson MR, Rice KC, Yin H, Watkins LR. Pharmacological characterization of the opioid inactive isomers (+)-naltrexone and (+)-naloxone as antagonists of toll-like receptor 4. Br J Pharmacol. 2016 Mar;173(5):856-69. doi: 10.1111/bph.13394. Epub 2016 Feb 4.
PubMed 26603732Kato J, Svensson CI. Role of extracellular damage-associated molecular pattern molecules (DAMPs) as mediators of persistent pain. Prog Mol Biol Transl Sci. 2015;131:251-79. doi: 10.1016/bs.pmbts.2014.11.014. Epub 2015 Jan 30.
PubMed 25744676Lewis SS, Loram LC, Hutchinson MR, Li CM, Zhang Y, Maier SF, Huang Y, Rice KC, Watkins LR. (+)-naloxone, an opioid-inactive toll-like receptor 4 signaling inhibitor, reverses multiple models of chronic neuropathic pain in rats. J Pain. 2012 May;13(5):498-506. doi: 10.1016/j.jpain.2012.02.005. Epub 2012 Apr 20.
PubMed 22520687Watkins LR, Hutchinson MR, Ledeboer A, Wieseler-Frank J, Milligan ED, Maier SF. Norman Cousins Lecture. Glia as the "bad guys": implications for improving clinical pain control and the clinical utility of opioids. Brain Behav Immun. 2007 Feb;21(2):131-46. doi: 10.1016/j.bbi.2006.10.011. Epub 2006 Dec 18.
PubMed 17175134Hutchinson MR, Zhang Y, Brown K, Coats BD, Shridhar M, Sholar PW, Patel SJ, Crysdale NY, Harrison JA, Maier SF, Rice KC, Watkins LR. Non-stereoselective reversal of neuropathic pain by naloxone and naltrexone: involvement of toll-like receptor 4 (TLR4). Eur J Neurosci. 2008 Jul;28(1):20-9. doi: 10.1111/j.1460-9568.2008.06321.x.
PubMed 18662331Wieseler J, Ellis A, McFadden A, Stone K, Brown K, Cady S, Bastos LF, Sprunger D, Rezvani N, Johnson K, Rice KC, Maier SF, Watkins LR. Supradural inflammatory soup in awake and freely moving rats induces facial allodynia that is blocked by putative immune modulators. Brain Res. 2017 Jun 1;1664:87-94. doi: 10.1016/j.brainres.2017.03.011. Epub 2017 Mar 16.
PubMed 28322750Su M, Ran Y, He Z, Zhang M, Hu G, Tang W, Zhao D, Yu S. Inhibition of toll-like receptor 4 alleviates hyperalgesia induced by acute dural inflammation in experimental migraine. Mol Pain. 2018 Jan-Dec;14:1744806918754612. doi: 10.1177/1744806918754612. Epub 2018 Jan 8.
PubMed 29310498Dewall CN, Macdonald G, Webster GD, Masten CL, Baumeister RF, Powell C, Combs D, Schurtz DR, Stillman TF, Tice DM, Eisenberger NI. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010 Jul;21(7):931-7. doi: 10.1177/0956797610374741. Epub 2010 Jun 14.
PubMed 20548058Younger J, Mackey S. Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study. Pain Med. 2009 May-Jun;10(4):663-72. doi: 10.1111/j.1526-4637.2009.00613.x. Epub 2009 Apr 22.
PubMed 19453963Lipton RB, Baggish JS, Stewart WF, Codispoti JR, Fu M. Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study. Arch Intern Med. 2000 Dec 11-25;160(22):3486-92. doi: 10.1001/archinte.160.22.3486.
PubMed 11112243Kaki AM, El-Yaski AZ, Youseif E. Identifying neuropathic pain among patients with chronic low-back pain: use of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):422-8. doi: 10.1016/j.rapm.2005.05.013.
PubMed 16135345
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT06245902
- Acronym / sponsor ID
- ANODYNE-1 / ANODYNE-1 Version 1.3
- Conditions
- Migraine With or Without Aura
- Keywords
- Migraine Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Allodynic Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 7 Feb 2024 (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.
The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Naltrexone and Acetaminophen | Experimental | Drug: Naltrexone and AcetaminophenPatients take one capsule containing naltrexone and one capsule containing acetaminophen together for a qualifying migraine |
| Naltrexon/Acetaminophen-High Capsules | Experimental | Drug: Naltrexone and Acetaminophen-High DosePatient take one capsule containing naltrexone (high dose) and one capsule containing acetaminophen together for a qualifying migraine |
| Naltrexone Alone Capsules | Active comparator | Drug: Naltrexone Alone (regular dose)Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine |
| Acetaminophen Alone Capsules | Active comparator | Drug: Acetaminophen AlonePatient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine |
| Placebo Capsules | Placebo comparator | Drug: Matching PlaceboPatient take two capsule containing placebo together for a qualifying migraine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 years of age or older.
- History of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version) for at least one-year with first migraine prior to age 50.
- Migraine-associated nausea with ≥half of migraine attacks.
- 2 - 8 migraines per month in each of the previous 3 months.
- The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.
Key exclusion criteria (12 listed)
- The patient in the opinion of the investigator, may have medication-overuse headache pain (as defined by ICHD - 3 beta criteria for medication-overuse headache), (analgesic, opioid, ergotamine or triptan overuse) during the 3 months preceding screening.
- The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine).
- History of cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
- Initiation or change in medications with possible migraine prophylactic effects during 3 months before inclusion into the trial (E.g., calcium channel blockers, tricyclic antidepressants, beta-blockers, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), or Botox).
- Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
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 |
|---|---|---|
| Naltrexone and AcetaminophenNaltrexone plus acetaminophen | Drug | Naltrexone and Acetaminophen |
| Naltrexone and Acetaminophen-High DoseNaltrexon (high dose) plus acetaminophen | Drug | Naltrexon/Acetaminophen-High Capsules |
| Naltrexone Alone (regular dose)Naltrexone Alone plus Placebo | Drug | Naltrexone Alone Capsules |
| Acetaminophen AloneAcetaminophen Alone plus Placebo | Drug | Acetaminophen Alone Capsules |
| Matching PlaceboTwo Placebo capsules | Drug | Placebo Capsules |
Primary outcome
% of patients reporting no headache pain.
Time frame: 2 hours post-dose
Self-reported headache pain on a four-point Likert scale.
% of patients having absence of most bothersome migraine-associated symptom (MBS).
Time frame: 2 hours post-dose
MBS was prospectively identified at baseline. Self-reported MBS as present or absent.
% of patients who have "sustained pain freedom"
Time frame: 24-hour post-dose.
Defined as having no headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain within 24 hours after administration of the investigational drug.
3 secondary outcomes
% of patients having absence of nausea, photophobia, phonophobia, and neck/shoulder pain
Time frame: 24-hour post-dose.
% of patients who used rescue medications
Time frame: 2-24 hours
% of patients who had headache pain relapse.
Time frame: 2-48 hours
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 7 Feb 2024.
- Results publication: PubMed 26603732Wang X, Zhang Y, Peng Y, Hutchinson MR, Rice KC, Yin H, Watkins LR. Pharmacological characterization of the opioid inactive isomers (+)-naltrexone and (+)-naloxone as antagonists of toll-like receptor 4. Br J Pharmacol. 2016 Mar;173(5):856-69. doi: 10.1111/bph.13394. Epub 2016 Feb 4.
- Results publication: PubMed 25744676Kato J, Svensson CI. Role of extracellular damage-associated molecular pattern molecules (DAMPs) as mediators of persistent pain. Prog Mol Biol Transl Sci. 2015;131:251-79. doi: 10.1016/bs.pmbts.2014.11.014. Epub 2015 Jan 30.
- Results publication: PubMed 22520687Lewis SS, Loram LC, Hutchinson MR, Li CM, Zhang Y, Maier SF, Huang Y, Rice KC, Watkins LR. (+)-naloxone, an opioid-inactive toll-like receptor 4 signaling inhibitor, reverses multiple models of chronic neuropathic pain in rats. J Pain. 2012 May;13(5):498-506. doi: 10.1016/j.jpain.2012.02.005. Epub 2012 Apr 20.
- Results publication: PubMed 17175134Watkins LR, Hutchinson MR, Ledeboer A, Wieseler-Frank J, Milligan ED, Maier SF. Norman Cousins Lecture. Glia as the "bad guys": implications for improving clinical pain control and the clinical utility of opioids. Brain Behav Immun. 2007 Feb;21(2):131-46. doi: 10.1016/j.bbi.2006.10.011. Epub 2006 Dec 18.
- Results publication: PubMed 18662331Hutchinson MR, Zhang Y, Brown K, Coats BD, Shridhar M, Sholar PW, Patel SJ, Crysdale NY, Harrison JA, Maier SF, Rice KC, Watkins LR. Non-stereoselective reversal of neuropathic pain by naloxone and naltrexone: involvement of toll-like receptor 4 (TLR4). Eur J Neurosci. 2008 Jul;28(1):20-9. doi: 10.1111/j.1460-9568.2008.06321.x.
- Results publication: PubMed 28322750Wieseler J, Ellis A, McFadden A, Stone K, Brown K, Cady S, Bastos LF, Sprunger D, Rezvani N, Johnson K, Rice KC, Maier SF, Watkins LR. Supradural inflammatory soup in awake and freely moving rats induces facial allodynia that is blocked by putative immune modulators. Brain Res. 2017 Jun 1;1664:87-94. doi: 10.1016/j.brainres.2017.03.011. Epub 2017 Mar 16.
- Results publication: PubMed 29310498Su M, Ran Y, He Z, Zhang M, Hu G, Tang W, Zhao D, Yu S. Inhibition of toll-like receptor 4 alleviates hyperalgesia induced by acute dural inflammation in experimental migraine. Mol Pain. 2018 Jan-Dec;14:1744806918754612. doi: 10.1177/1744806918754612. Epub 2018 Jan 8.
- Results publication: PubMed 20548058Dewall CN, Macdonald G, Webster GD, Masten CL, Baumeister RF, Powell C, Combs D, Schurtz DR, Stillman TF, Tice DM, Eisenberger NI. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010 Jul;21(7):931-7. doi: 10.1177/0956797610374741. Epub 2010 Jun 14.
- Results publication: PubMed 19453963Younger J, Mackey S. Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study. Pain Med. 2009 May-Jun;10(4):663-72. doi: 10.1111/j.1526-4637.2009.00613.x. Epub 2009 Apr 22.
- Results publication: PubMed 11112243Lipton RB, Baggish JS, Stewart WF, Codispoti JR, Fu M. Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study. Arch Intern Med. 2000 Dec 11-25;160(22):3486-92. doi: 10.1001/archinte.160.22.3486.
- Results publication: PubMed 16135345Kaki AM, El-Yaski AZ, Youseif E. Identifying neuropathic pain among patients with chronic low-back pain: use of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale. Reg Anesth Pain Med. 2005 Sep-Oct;30(5):422-8. doi: 10.1016/j.rapm.2005.05.013.
- 2009-2013 Pain Research Advances \| Interagency Pain ...Thus, identifying potential new medications is critical. Recent evidence indicates a pivotal role for the receptor known as toll-like receptor 4 (TLR4 ...Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Migraine With or Without Aura
RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Not yet recruitingObservational study
A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea
Migraine With or Without Aura
Not yet recruitingPhase 3
Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
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.
Annette C Toledano, M.D. study director
Allodynic Therapeutics, Inc
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 Naltrexone and Acetaminophen, Naltrexone and Acetaminophen-High Dose and Naltrexone Alone (regular dose) in people with Migraine With or Without Aura, run by Allodynic Therapeutics, Inc 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 6 inclusion and 12 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 7 Feb 2024. 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 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?
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?
% of patients reporting no headache pain. (time frame: 2 hours post-dose). The study lists 3 primary outcomes in all. 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 NCT06245902, which also lists 11 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 7 Feb 2024.