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Oral ALLOD-2 vs. Its Components & vs. Placebo in the Acute Treatment of Migraine (ANODYNE-1)

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ClinicalTrials.gov Identifier: NCT03061734
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Allodynic Therapeutics, LLC

Brief Summary:

This proof -of-concept study compares ALLOD-2 to its individual components and to placebo.

The investigational product (ALLOD-2), is a combination of two marketed drugs. Both drugs are used at a much lower doses than the doses used for the approved indications.

The combination is a First-in-Class drug due to its new and unique mechanism of action.


Condition or disease Intervention/treatment Phase
Migraine With or Without Aura Drug: ALLOD-2 Drug: ALLOD-2H Drug: Component A (regular dose) Drug: Component B Drug: Placebo Phase 2 Phase 3

Detailed Description:
The study consists of a screening visit, at home treatment of a migraine attack with a single dose of the study drug within 8 weeks, and End-of-Study Visit 2-7 days after treatment of a moderate or severe migraine attack.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Center, Phase 2B, Randomized, Double-Blind, Placebo, Individual Components, and 2-Doses, Controlled Pilot Study to Assess the Efficacy and Safety of a Single Dose of ALLOD-2 in the Acute Treatment of Migraine (ANODYNE-1)
Actual Study Start Date : February 18, 2017
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: ALLOD-2 Capsules
Each patient receives one capsule containing component A (regular dose) and one capsule containing component B and uses both capsules together for treatment of a qualified Migraine attack
Drug: ALLOD-2
ALLOD-2: Component A (regular dose) plus Component B

Experimental: ALLOD-2H Capsules
Each patient receives one capsule containing component A (high dose) and one capsule containing component B and uses both capsules together for treatment of a qualified Migraine attack
Drug: ALLOD-2H
ALLOD-2H: Component A (high dose) plus Component B

Active Comparator: Active Comparator Component A Capsules
Each patient receives one capsule containing component A of ALLOD-2 and one capsule containing a placebo comparator for component B of ALLOD-2 and uses both capsules together for treatment of a qualified Migraine attack
Drug: Component A (regular dose)
Component A (regular dose) of ALLOD-2

Active Comparator: Active Comparator Component B Capsules
Each patient receives one capsule containing component B of ALLOD-2 and one capsule containing a placebo comparator for component A of ALLOD-2 and uses both capsules together for treatment of a qualified Migraine attack
Drug: Component B
Component B of ALLOD-2

Placebo Comparator: Placebo Capsules
Each patient receives one capsule containing a placebo comparator for component A of ALLOD-2 and one capsule containing a placebo comparator for component B of ALLOD-2 and uses both capsules together for treatment of a qualified Migraine attack
Drug: Placebo
Placebo for Component A plus Placebo for Component B




Primary Outcome Measures :
  1. The proportion of patients having no headache pain for ALLOD-2 vs. placebo at 2 hours. [ Time Frame: 2 hours ]
    Measured by asking patients to self-report the current status of their headache pain on a four-point Likert scale (i.e., 0=none, 1=mild, 2=moderate, 3=severe).

  2. The proportion of patients having absence of most bothersome migraine-associated symptom-for ALLOD-2 vs. placebo at 2 hours. [ Time Frame: 2 hours ]
    Most bothersome migraine-associated symptom is prospectively identified at baseline. It is measured by asking patients to self-report the current status of their associated symptom as present or absent.


Secondary Outcome Measures :
  1. The proportion of patients having absence of nausea, photophobia, phonophobia, and neck/shoulder pain for ALLOD-2 and ALLOD-2H vs. placebo at 2 hours. [ Time Frame: 2 hours ]
    Measured by asking patients to self-report the current status of their associated symptom as present or absent.

  2. The proportion of patients having no headache pain for ALLOD-2 vs. component A and vs. component B at 2 hours. [ Time Frame: 2 hours ]
    Measured by asking patients to self-report the current status of their headache pain on a four-point Likert scale (i.e., 0=none, 1=mild, 2=moderate, 3=severe).

  3. The proportion of patients who used rescue medications for ALLOD-2 vs. placebo within 24 hours. [ Time Frame: 2-24 hours ]
  4. The proportion of patients who are "sustained pain free" for ALLOD-2 vs. placebo at 24-hour and 48-hour. [ Time Frame: 24 and 48 hours ]
    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 (24-hour sustained pain-free) or 48 hours (48-hour sustained pain-free) after administration of the investigational drug.

  5. The proportion of patients who had headache pain relapse for ALLOD-2 versus placebo within 48 hours. [ Time Frame: 48 hours ]
    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.


Other Outcome Measures:
  1. The proportion of patients who experienced adverse events [ Time Frame: 48 hours ]
    treatment related Adverse Events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18 years of age or older.
  2. 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.
  3. Migraine-associated nausea with ≥half of migraine attacks.
  4. 2 - 8 migraines per month in each of the previous 3 months.
  5. 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.
  6. 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.

Exclusion Criteria:

  1. 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.
  2. The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine).
  3. History of cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
  4. 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).
  5. Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
  6. A history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
  7. 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.
  8. Use of opiates or barbiturates more than 3 days per month.
  9. Known-hypersensitivity reaction to any of the components of the investigational drug.
  10. Consumption of analgesic medication for other conditions on a regular basis, (nonsteroidal anti-inflammatory drugs, or acetaminophen, or muscle relaxants).
  11. Use of emergency care treatment more than 3 times in the previous 6 months.
  12. Participation in another study with an investigational drug within 30 days prior to randomization and/or a plan to participate during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061734


Locations
United States, Florida
Annette C. Toledano MD
North Miami, Florida, United States, 33181
Sponsors and Collaborators
Allodynic Therapeutics, LLC
Investigators
Study Director: Annette C Toledano, M.D. Allodynic Therapeutics, LLC

Responsible Party: Allodynic Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT03061734     History of Changes
Other Study ID Numbers: ANODYNE-1
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allodynic Therapeutics, LLC:
Migraine Disorders
Headache Disorders
Migraine with Aura
Migraine without Aura

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases