Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial
NCT ID: NCT05685225
Last Updated: 2025-12-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2025-01-31
Study Completion Date
2025-12-02
Brief Summary
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* This two-stage clinical trial will assess a novel combination therapy for acute migraine. In Stage 1 (factorial), participants will receive the combination, each individual component, or placebo. In Stage 2 (dose-finding), they will test three doses of the combination. Before both stages, participants will complete a run-in period, documenting a migraine attack without study medication. They will then treat one migraine attack in each stage.
* 4 visits
* Requirements: Migraine Diagnosis. BMI below 34. Read, write, and speak English. No opioids, marijuana, benzodiazepines, or excessive alcohol.
* 4 visits
* Requirements: Migraine Diagnosis. BMI below 34. Read, write, and speak English. No opioids, marijuana, benzodiazepines, or excessive alcohol.
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Detailed Description
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This study evaluating naltrexone-acetaminophen in the acute treatment of migraine.
Conditions
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Migraine
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Stage 1: Naltrexone/Acetaminophen
One dose for a Qualifying Migraine Attack
Group Type
EXPERIMENTAL
Stage 1: Naltrexone/Acetaminophen
Intervention Type
DRUG
Combination
Stage 1: Naltrexone
One dose for a Qualifying Migraine Attack
Group Type
ACTIVE_COMPARATOR
Stage 1: Naltrexone
Intervention Type
DRUG
Naltrexone alone
Satge 1: Acetaminophen
One dose for a Qualifying Migraine Attack
Group Type
ACTIVE_COMPARATOR
Stage 1: Acetaminophen
Intervention Type
DRUG
Acetaminophen alone
Stage 1: Placebo
One dose for a Qualifying Migraine Attack
Group Type
PLACEBO_COMPARATOR
Stage1: Placebo
Intervention Type
DRUG
Matching placebo
Stage 2: Naltrexone/Acetaminophen-high dose
One dose for a qualifying migraine attack
Group Type
EXPERIMENTAL
Stage 2: Naltrxone/Acetaminophen high dose
Intervention Type
DRUG
Combination high dose
Stage 2: Naltrexone/Acetaminophen-medium dose
One dose for a qualifying migraine attack
Group Type
EXPERIMENTAL
Stage 2: Naltrexone/Acetaminophen medium dose
Intervention Type
DRUG
Combination medium dose
Stage 2: Naltrexone/Acetaminophen-low dose
One dose for a qualifying migraine attack
Group Type
EXPERIMENTAL
Stage 2: Naltrxone/Acetaminophen low dose
Intervention Type
DRUG
Combination low dose
Stage 2: Placebo
One dose for a qualifying migraine attack
Group Type
PLACEBO_COMPARATOR
Stage 2: Placebo
Intervention Type
DRUG
Matching Placebo
Interventions
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Stage 1: Naltrexone/Acetaminophen
Combination
Intervention Type
DRUG
Stage 1: Naltrexone
Naltrexone alone
Intervention Type
DRUG
Stage 1: Acetaminophen
Acetaminophen alone
Intervention Type
DRUG
Stage1: Placebo
Matching placebo
Intervention Type
DRUG
Stage 2: Naltrxone/Acetaminophen high dose
Combination high dose
Intervention Type
DRUG
Stage 2: Naltrexone/Acetaminophen medium dose
Combination medium dose
Intervention Type
DRUG
Stage 2: Naltrxone/Acetaminophen low dose
Combination low dose
Intervention Type
DRUG
Stage 2: Placebo
Matching Placebo
Intervention Type
DRUG
Other Intervention Names
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ALLOD-2
ALLOD-2
ALLOD-2
ALLOD-2
Eligibility Criteria
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Inclusion Criteria
1. Ages 18 to 75 years, inclusive.
2. At least 1-year of history of migraine with or without aura as defined by the International Classification of Headache Disorders 3rd edition 17 (ICHD-3).
3. Migraine onset before age 50 years.
4. Read, write, and speak English
5. BMI Higher than 20 and Lower than 34
6. The female subject who is premenopausal or postmenopausal less than one 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 two methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study medication (e.g., barrier with an additional spermicidal, intra- uterine device, hormonal contraception). Male subjects must be surgically sterile (the procedure occurred greater than 6 months before the Screening Visit) or commit to using two different birth control methods during the study and for 28 days after the last dose of the study medication.
2. At least 1-year of history of migraine with or without aura as defined by the International Classification of Headache Disorders 3rd edition 17 (ICHD-3).
3. Migraine onset before age 50 years.
4. Read, write, and speak English
5. BMI Higher than 20 and Lower than 34
6. The female subject who is premenopausal or postmenopausal less than one 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 two methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study medication (e.g., barrier with an additional spermicidal, intra- uterine device, hormonal contraception). Male subjects must be surgically sterile (the procedure occurred greater than 6 months before the Screening Visit) or commit to using two different birth control methods during the study and for 28 days after the last dose of the study medication.
Exclusion Criteria
1. Pregnant or nursing women or those planning a pregnancy.
2. Used opioids (including methadone and buprenorphine), barbiturate-containing medications, muscle relaxants, or benzodiazepines within 3 months prior to screening.
3. Used any recreational drugs in the past 3 months.
4. Use of medications to treat headaches more than 10 days per month in the past 3 months or use of any pain medication for other pain syndromes for more than 10 days per month.
5. Uncontrolled cardiovascular or cerebrovascular disease or a history of heart failure, atrial fibrillation, or myocardial infarction.
6. Uncontrolled hypertension (systolic/diastolic blood pressure ˃ 140/90 mmHg) or diabetes.
7. Immediate family members or same household members participating in the study.
8. Site personnel, their friends, and family.
9. Abnormal laboratory or ECG results.
1. Aspartate transaminase (AST/SGOT), alanine transaminase (ALT/SGPT), or alkaline Phosphatase ≥ 1.5 x Upper Limit of Normal (ULN). creatinine ≥ 1.5 x ULN.
2. BBB or intraventricular conduction defect with a QRS duration ≥ 150 msec. ST-T wave abnormalities.
3. Hemoglobin \< 10 g/dL
4. Neutrophil count ≤ 1000/μL
5. Cholesterol ≥ 300 mg/dL
2. Used opioids (including methadone and buprenorphine), barbiturate-containing medications, muscle relaxants, or benzodiazepines within 3 months prior to screening.
3. Used any recreational drugs in the past 3 months.
4. Use of medications to treat headaches more than 10 days per month in the past 3 months or use of any pain medication for other pain syndromes for more than 10 days per month.
5. Uncontrolled cardiovascular or cerebrovascular disease or a history of heart failure, atrial fibrillation, or myocardial infarction.
6. Uncontrolled hypertension (systolic/diastolic blood pressure ˃ 140/90 mmHg) or diabetes.
7. Immediate family members or same household members participating in the study.
8. Site personnel, their friends, and family.
9. Abnormal laboratory or ECG results.
1. Aspartate transaminase (AST/SGOT), alanine transaminase (ALT/SGPT), or alkaline Phosphatase ≥ 1.5 x Upper Limit of Normal (ULN). creatinine ≥ 1.5 x ULN.
2. BBB or intraventricular conduction defect with a QRS duration ≥ 150 msec. ST-T wave abnormalities.
3. Hemoglobin \< 10 g/dL
4. Neutrophil count ≤ 1000/μL
5. Cholesterol ≥ 300 mg/dL
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Allodynic Therapeutics, Inc
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Annette C Toledano, MD
Role: STUDY_DIRECTOR
Allodynic Therapeutics, Inc
Natalia Belikova, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Keystone Clinical Research
Locations
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Keystone Clinical Research
North Miami, Florida, United States
Site Status
Countries
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United States
References
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Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, Mitchell AA. Recent patterns of medication use in the ambulatory adult population of the United States: the Slone survey. JAMA. 2002 Jan 16;287(3):337-44. doi: 10.1001/jama.287.3.337.
Reference Type
BACKGROUND
Krenzelok EP, Royal MA. Confusion: acetaminophen dosing changes based on NO evidence in adults. Drugs R D. 2012 Jun 1;12(2):45-8. doi: 10.2165/11633010-000000000-00000.
Reference Type
BACKGROUND
Prescott LF. Kinetics and metabolism of paracetamol and phenacetin. Br J Clin Pharmacol. 1980 Oct;10 Suppl 2(Suppl 2):291S-298S. doi: 10.1111/j.1365-2125.1980.tb01812.x.
Reference Type
BACKGROUND
Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL. Gastric stasis in migraineurs: etiology, characteristics, and clinical and therapeutic implications. Cephalalgia. 2013 Apr;33(6):408-15. doi: 10.1177/0333102412473371. Epub 2013 Mar 5.
Reference Type
BACKGROUND
Alstadhaug K, Salvesen R, Bekkelund S. 24-hour distribution of migraine attacks. Headache. 2008 Jan;48(1):95-100. doi: 10.1111/j.1526-4610.2007.00779.x.
Reference Type
BACKGROUND
Pascual J. Clinical benefits of early triptan therapy for migraine. Headache. 2002 Jan;42 Suppl 1:10-7. doi: 10.1046/j.1526-4610.2002.0420s1010.x.
Reference Type
BACKGROUND
Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482.
Reference Type
BACKGROUND
Lipton RB, Scher AI, Kolodner K, Liberman J, Steiner TJ, Stewart WF. Migraine in the United States: epidemiology and patterns of health care use. Neurology. 2002 Mar 26;58(6):885-94. doi: 10.1212/wnl.58.6.885.
Reference Type
BACKGROUND
Brandes JL. Global trends in migraine care: results from the MAZE survey. CNS Drugs. 2002;16 Suppl 1:13-8. doi: 10.2165/00023210-200216001-00003.
Reference Type
BACKGROUND
Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009 May;84(5):422-35. doi: 10.1016/S0025-6196(11)60561-2.
Reference Type
BACKGROUND
Lipton RB, Hamelsky SW, Dayno JM. What do patients with migraine want from acute migraine treatment? Headache. 2002 Jan;42 Suppl 1:3-9. doi: 10.1046/j.1526-4610.2002.0420s1003.x.
Reference Type
BACKGROUND
Bigal ME, Serrano D, Buse D, Scher A, Stewart WF, Lipton RB. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache. 2008 Sep;48(8):1157-68. doi: 10.1111/j.1526-4610.2008.01217.x.
Reference Type
BACKGROUND
Cree BA, Kornyeyeva E, Goodin DS. Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis. Ann Neurol. 2010 Aug;68(2):145-50. doi: 10.1002/ana.22006.
Reference Type
BACKGROUND
Lipton 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.
Reference Type
BACKGROUND
Wieseler 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.
Reference Type
BACKGROUND
Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499.
Reference Type
BACKGROUND
Chopra P, Cooper MS. Treatment of Complex Regional Pain Syndrome (CRPS) using low dose naltrexone (LDN). J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. doi: 10.1007/s11481-013-9451-y. Epub 2013 Apr 2.
Reference Type
BACKGROUND
Hutchinson 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.
Reference Type
BACKGROUND
Nicotra L, Loram LC, Watkins LR, Hutchinson MR. Toll-like receptors in chronic pain. Exp Neurol. 2012 Apr;234(2):316-29. doi: 10.1016/j.expneurol.2011.09.038. Epub 2011 Oct 6.
Reference Type
BACKGROUND
Ellis A, Wieseler J, Favret J, Johnson KW, Rice KC, Maier SF, Falci S, Watkins LR. Systemic administration of propentofylline, ibudilast, and (+)-naltrexone each reverses mechanical allodynia in a novel rat model of central neuropathic pain. J Pain. 2014 Apr;15(4):407-21. doi: 10.1016/j.jpain.2013.12.007. Epub 2014 Jan 9.
Reference Type
BACKGROUND
Lewis 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Selfridge BR, Wang X, Zhang Y, Yin H, Grace PM, Watkins LR, Jacobson AE, Rice KC. Structure-Activity Relationships of (+)-Naltrexone-Inspired Toll-like Receptor 4 (TLR4) Antagonists. J Med Chem. 2015 Jun 25;58(12):5038-52. doi: 10.1021/acs.jmedchem.5b00426. Epub 2015 Jun 5.
Reference Type
BACKGROUND
Roberts ID, Krajbich I, Way BM. Acetaminophen influences social and economic trust. Sci Rep. 2019 Mar 11;9(1):4060. doi: 10.1038/s41598-019-40093-9.
Reference Type
BACKGROUND
Dewall 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.
Reference Type
BACKGROUND
Wardle MC, Bershad AK, de Wit H. Naltrexone alters the processing of social and emotional stimuli in healthy adults. Soc Neurosci. 2016 Dec;11(6):579-91. doi: 10.1080/17470919.2015.1136355. Epub 2016 Jan 22.
Reference Type
BACKGROUND
Devlen J. Anxiety and depression in migraine. J R Soc Med. 1994 Jun;87(6):338-41.
Reference Type
BACKGROUND
Buse DC, Reed ML, Fanning KM, Bostic R, Dodick DW, Schwedt TJ, Munjal S, Singh P, Lipton RB. Comorbid and co-occurring conditions in migraine and associated risk of increasing headache pain intensity and headache frequency: results of the migraine in America symptoms and treatment (MAST) study. J Headache Pain. 2020 Mar 2;21(1):23. doi: 10.1186/s10194-020-1084-y.
Reference Type
BACKGROUND
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
Reference Type
BACKGROUND
Edmeads J, Findlay H, Tugwell P, Pryse-Phillips W, Nelson RF, Murray TJ. Impact of migraine and tension-type headache on life-style, consulting behaviour, and medication use: a Canadian population survey. Can J Neurol Sci. 1993 May;20(2):131-7. doi: 10.1017/s0317167100047697.
Reference Type
BACKGROUND
Kwilasz AJ, Todd LS, Duran-Malle JC, Schrama AEW, Mitten EH, Larson TA, Clements MA, Harris KM, Litwiler ST, Wang X, Van Dam AM, Maier SF, Rice KC, Watkins LR, Barrientos RM. Experimental autoimmune encephalopathy (EAE)-induced hippocampal neuroinflammation and memory deficits are prevented with the non-opioid TLR2/TLR4 antagonist (+)-naltrexone. Behav Brain Res. 2021 Jan 1;396:112896. doi: 10.1016/j.bbr.2020.112896. Epub 2020 Sep 6.
Reference Type
BACKGROUND
Kato 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.
Reference Type
BACKGROUND
Parkitny L, Younger J. Reduced Pro-Inflammatory Cytokines after Eight Weeks of Low-Dose Naltrexone for Fibromyalgia. Biomedicines. 2017 Apr 18;5(2):16. doi: 10.3390/biomedicines5020016.
Reference Type
BACKGROUND
Su 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.
Reference Type
BACKGROUND
Gudala K, Bansal D, Vatte R, Ghai B, Schifano F, Boya C. High Prevalence of Neuropathic Pain Component in Patients with Low Back Pain: Evidence from Meta-Analysis. Pain Physician. 2017 Jul;20(5):343-352.
Reference Type
BACKGROUND
Cant R, Dalgleish AG, Allen RL. Naltrexone Inhibits IL-6 and TNFalpha Production in Human Immune Cell Subsets following Stimulation with Ligands for Intracellular Toll-Like Receptors. Front Immunol. 2017 Jul 11;8:809. doi: 10.3389/fimmu.2017.00809. eCollection 2017.
Reference Type
BACKGROUND
Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005 Jan-Feb;12(1):46-55. doi: 10.1097/00045391-200501000-00008.
Reference Type
BACKGROUND
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
Reference Type
BACKGROUND
HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
Reference Type
BACKGROUND
Bihari B. Bernard Bihari, MD: low-dose naltrexone for normalizing immune system function. Altern Ther Health Med. 2013 Mar-Apr;19(2):56-65. No abstract available.
Reference Type
BACKGROUND
Younger 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.
Reference Type
BACKGROUND
Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.
Reference Type
BACKGROUND
Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS. Low-dose naltrexone therapy improves active Crohn's disease. Am J Gastroenterol. 2007 Apr;102(4):820-8. doi: 10.1111/j.1572-0241.2007.01045.x. Epub 2007 Jan 11.
Reference Type
BACKGROUND
Other Identifiers
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AT-06
Identifier Type: -
Identifier Source: org_study_id
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