MIGERGOT (caffeine)
Migergot is a combination of ergotamine tartrate and caffeine indicated for the management of vascular headaches. It is used by patients to either abort or prevent the occurrence of migraine and migraine variants. Additionally, the medication is approved for the treatment of histaminic cephalalgia.
How MIGERGOT Works
The specific mechanism of action for this medication is not specified in the provided FDA label. The drug is pharmacologically categorized as a central nervous system stimulant and a methylxanthine. These classifications define the general biological framework through which the medication addresses vascular headache conditions.
Details
- Status
- Prescription
- First Approved
- 1983-10-04
- Routes
- RECTAL
- Dosage Forms
- SUPPOSITORY
MIGERGOT Approval History
What MIGERGOT Treats
3 indicationsMIGERGOT is approved for 3 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vascular Headache
- Migraine
- Histaminic Cephalalgia
MIGERGOT Boxed Warning
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTR...
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONS and WARNINGS section)
MIGERGOT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MIGERGOT
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Clinical Trial Registry
74 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06686628 | INT18404 U1111-1303-3406, 2024-513495-17 | Ph 1 | completed | An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates |
| NCT04570085 CAFCA | 2018_95 2019-002360-27 | Ph 3 | recruiting | Effect of CAFfeine on Cognition in Alzheimer's Disease |
| NCT06564441 | 1404-0008 2024-512332-29-00, U1111-1307-0132 | Ph 1 | completed | A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity |
| NCT07456670 CARES-Pilot | TRAQ 73767 | Ph 2 | not yet recruiting | Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support |
| NCT06327152 | 2659 | Ph 2 | active not recruiting | Caffeine Use in the Management of Preterm Infants |
| NCT06973005 CRIOLLO | D7930C00007 | Ph 1 | completed | A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants |
| NCT06917508 | EDP 323-006 | Ph 1 | completed | A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants |
| NCT05485805 results posted | 22093 2022-003274-22 | Ph 3 | completed | A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo |
| NCT03556592 | LP0162-1342 2018-000534-35 | Ph 1 | completed | Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4 |
| NCT06632990 | ALX-923-108 SB1AG087748 | Ph 1 | active not recruiting | A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates |
| NCT01950520 results posted | 130200 13-DK-0200 | Ph 2 | completed | Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate |
| NCT03864042 results posted | ARRAY-818-103 C4221003, 2019-001036-66 | Ph 1 | completed | Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors |
| NCT04246762 results posted | CL04041026 | Ph 1 | completed | Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4 |
| NCT05067439 results posted | B7451092 | Ph 1 | completed | A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants |
| NCT03400423 AEC | Acute Exercise and Caffeine | Ph 4 | completed | The Acute Effects of Caffeine on Exercise and Cognition |
| NCT02323698 results posted | 2017P001940b 5R01HD081274 | Ph 1, Ph 2 | completed | Effects of Caffeine and Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury |
| NCT05932277 | CN007-1000 | Ph 1 | completed | A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants |
| NCT05852769 | IM038-022 | Ph 1 | completed | A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants |
| NCT03321734 ICAF | R01HD089289 1R01HD089289-01A1 | Ph 2 | completed | Intermittent Hypoxia and Caffeine in Infants Born Preterm |
| NCT05685407 | 00002778 | Ph 1 | completed | Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women |
| NCT02740712 DDI | CO-338-044 | Ph 1 | completed | Pharmacokinetic Drug-Drug Interaction Study of Rucaparib |
| NCT05594615 | EDP 235-003 | Ph 1 | completed | Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects |
| NCT05445232 | 18476 J1I-MC-GZBI | Ph 1 | completed | A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants |
| NCT04504045 | AKF-395 2020-000162-42 | Ph 1 | terminated | Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes |
| NCT05121714 | ABX464-902 | Ph 1 | completed | Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464 |
| NCT04643249 | KL1333 2020-103 | Ph 1 | completed | Drug-drug Interaction Study of KL1333 in Healthy Subjects |
| NCT04132336 results posted | 21069 2019-003513-33 | Ph 2 | completed | Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed |
| NCT04655040 | B7981054 | Ph 1 | completed | Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants |
| NCT03432793 | 0172 | Ph 1 | completed | Drug-Drug Interaction (DDI) Study for TD-9855 |
| NCT01596647 | CTKI258A2119 2011-001489-16 | Ph 1 | completed | Pharmacokinetic Drug-drug Interaction Study of Dovitinib (TKI258) in Patients With Advanced Solid Tumors |
| NCT02520752 | CINC280A2103 | Ph 1 | completed | A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors |
| NCT02760615 | Vedolizumab-4002 U1111-1171-3187 | Ph 4 | withdrawn | Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study |
| NCT02655614 | GN29823 2017-002931-41 | Ph 1 | completed | A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis |
| NCT01275170 results posted | 7655-005 | Ph 1 | completed | A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005) |
| NCT03970798 | 6356-005 | Ph 1 | completed | A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin |
| NCT03360903 results posted | IRB17-1174 1R01GM116119 | Ph 4 | completed | A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia |
| NCT03910088 PDPH | CairoU11112017 | Ph 4 | completed | Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean |
| NCT03022838 | 2015/1729REK | Ph 2, Ph 3 | terminated | The Effects of Caffeine Withdrawal on Migraine |
| NCT03003000 results posted | 1335.5 2016-000902-12 | Ph 3 | completed | Ibuprofen/Caffeine Lower Back or Neck Pain Study |
| NCT01517399 | ARQ197-A-U158 | Ph 1 | completed | Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects |
| NCT01783561 EARLYCAFFEINE results posted | 2HRCAFFEINE | Ph 4 | completed | Early Versus Routine Caffeine Administration in Extremely Preterm Neonates |
| NCT02567968 results posted | IRB15-0897 1R01GM116119-01 | Ph 4 | completed | A Study to Determine if Caffeine Accelerates Emergence From Anesthesia |
| NCT02361619 D-cocktail | T162/2014 2014-003628-38 | Ph 1 | completed | Dabigatran in an Interaction Probe Drug Cocktail |
| NCT00964106 | 112684 | Ph 1 | completed | Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation |
| NCT03131973 | IM014-013 | Ph 1 | completed | Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin |
| NCT02685462 | 652-124 | Ph 1 | completed | Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin |
| NCT02772601 | M16-007 2015-005523-31, 1311.36 | Ph 1 | completed | This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic Arthritis |
| NCT02397382 | CR106796 CNTO1959PSO1003 | Ph 1 | completed | Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis |
| NCT03187496 | EDP 305-004 | Ph 1 | completed | Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers. |
| NCT02225093 | 9785-CL-0406 | Ph 1 | completed | A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer |
Showing 50 of 74 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIGERGOT FDA Label Details
Indications & Usage
MIGERGOT is indicated for the treatment of Vascular Headache; Migraine; Histaminic Cephalalgia.
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tar...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.