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Chronic MigrainePhase 2NCT01813591

A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines

A Phase 2 study testing H.P. Acthar Gel in people with Chronic Migraine, run by Dent Neuroscience Research Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This small study is to investigate the efficacy of Acthar in the treatment of chronic migraine in patients who have failed multiple treatments, including Botox (which is defined as having <30% reduction from baseline in the number of headache days per month). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Migraine
What is being tested?
H.P. Acthar Gel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesUnited States
Study dates
Apr 2013to Nov 2015
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Is male or female, 18 to 60 years of age.
  • Has a history of chronic migraine as classified by the International Headache Classification, ICHD-2R (i.e. must demonstrate an average of >=15 headache days per month, of which >=8 must be migraine days or >=8 days of migraine-specific acute medication-ergotamine or triptans for at least 3 months prior to study.
  • Must demonstrate at least >=8 migraine days or >=8 days of migraine specific acute medications- ergotamine or triptans during 30 day baseline screening.
  • Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache).
  • Will have a previous history of failing at least one prophylactic treatment, which can include anti-seizure medications and/or TCA's prescribed for the treatment of chronic migraine.
  • Must be considered a non-responder to previous treatment with Botox. Botox failure will be defined by previous documentation (at the discretion of the PI) or as having less than 30% reduction of headache days per month on Botox.
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  • Will have not had botulinum toxin with in 4 months before study enrollment.
  • If female of childbearing potential, will have a negative urine pregnancy test at Visits 1 and 7, and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator.
  • Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug (a minimum of 7 days); or,
  • Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,
  • Sterilization of male partner; or,
  • Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,
  • Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or,
  • Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study. Protocol Number/v.1/06 Jun 2012 7
  • Must be in generally good health as confirmed by medical history, baseline physical exam, baseline neurological exam and vital signs.

Who cannot join

  • Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
  • Is pregnant, actively trying to become pregnant, or breast-feeding.
  • Has a significant systemic disease that is equally painful or more painful than migraine.
  • Has a progressive neurological disorder such as MS.
  • Has a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome such as HIV.
  • Has sensitivity to proteins of porcine origin.
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  • Has a known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [> or equal to 126 mg/dL or > or equal to 7 mmol/L if fasting;> or equal to 200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus), or a known or 'new' diagnosis of hypothyroidism not adequately controlled with medication.
  • Has previously taken Acthar for any reason.
  • Has any contraindications listed on the Acthar PI.
  • Has a history of cluster headache, chronic tension type headache, or headache due to medication over use according to IHS guidelines, in the 3 months prior to study enrollment or during the baseline phase.
  • Has received any other investigative drug 30 days prior to enrollment in this study.
  • Who in the opinion of the Principal Investigator has a condition for which they should not be enrolled in the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Baylor University Medical Center

    Dallas, Texas, 75231

  • Renown Institute of Neurosciences

    Reno, Nevada, 89502

  • Clinvest/A Division of Banyan Group, Inc.

    Springfield, Missouri, 65807

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Parallel Two-Arm Study Evaluating the Efficacy of H.P. Acthar Injection Gel in the Treatment of Adults With Intractable Chronic Migraine

This small study is to investigate the efficacy of Acthar in the treatment of chronic migraine in patients who have failed multiple treatments, including Botox (which is defined as having <30% reduction from baseline in the number of headache days per month). Despite the widespread use of anti-seizure medications, there remain a significant number of patient whose migraines are refractory to these agents. The pathophysiology of migraine is such that the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are released at the trigeminal nerve endings innervating the large cranial and dura mater blood vessels and this neurotrasmission generates migraine associated pain. Because of this, treatment for migraine can be directed towards down regulating those receptor sites accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to inhibit the release of CGRP and may also provide relief through a negative feedback loop as exogenous ACTH inhibits CRH release and mast cell degranulation.

Being tested
H.P. Acthar Gel
Keywords
Chronic Migraine, Headache, Refractory Chronic Migraine
Medical subject headings
Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H.P. Acthar GelDrug

    Also called Acthar, Repository Corticotropin Injection, ACTH Gel

    Acthar (40IU or 80IU) given subcutaneously for 5 days in the 1st week, followed by every other day (3 times per week for the next 3 weeks)

Study groups in NCT01813591
Study groupRoleWhat they receive
H.P. Acthar Gel 80IUExperimentalH.P. Acthar Gel of 80IU (1.0 ml)
Receives: Drug: H.P. Acthar Gel
H.P. Acthar Gel 40IUExperimentalH.P. Acthar Gel of 40IU (0.5 mL)
Receives: Drug: H.P. Acthar Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average total number of headache days (both 40IU and 80IU groups)

    Comparison of the average total number of headache days after 30 days of Acthar treatment (both 40IU and 80IU groups)with the average number of headache days at baseline screening period

    Measured: After 30 days of treatment

Secondary outcomes (1)

  1. Total number of headache days (both 40IU and 80IU groups)

    Comparison of the total number of headache days after 30 days of Acthar treatment (both 40IU and 80IU groups) with the number of headache days at baseline screening period

    Measured: After 30 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2014
  4. Study completionNov 2015

Resources

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
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01813591
Sponsor's protocol ID
ACTHAR
Status last verified
Jul 2018
First submitted
15 Mar 2013
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing H.P. Acthar Gel in people with Chronic Migraine, run by Dent Neuroscience Research Center at 4 sites 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 15 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. 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?

Average total number of headache days (both 40IU and 80IU groups) (time frame: After 30 days of treatment). 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 NCT01813591.

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 26 Jul 2018.

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