Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine

NCT02571049 | Completed Phase 2 Results

• 1 other identifier: DFN-11-CD-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches.

Conditions

Rapidly Escalating Migraine

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment

  60 minutes post-treatment

Study Arms (2)

Sumatriptan 3 mg then 6 mg

EXPERIMENTAL

DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections

Drug: DFN-11

Sumatriptan 6 mg then 3 mg

EXPERIMENTAL

Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo

Drug: DFN-11

Interventions

DFN-11 DRUG

Sumatriptan 3 mg versus 6 mg

Also known as: Sumatriptan succinate injection

Sumatriptan 3 mg then 6 mg; Sumatriptan 6 mg then 3 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of episodic migraine, with or without aura for at least 1 year prior to screening
• Experience an average of 2 to 8 migraines per month for the past 12 months of which approximately 75% or more rapidly escalate to moderate or severe pain within 2 hours of onset
• Females must:
• be practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], or male partner sterilization) before entry and throughout the study, or
• be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
• be postmenopausal (spontaneous amenorrhea for at least 1 year)
• Females of child-bearing potential must have a negative urine pregnancy test at screening
• Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol
• Must have internet access to complete daily headache diary

You may not qualify if:

• Inability to distinguish migraine from other primary headaches
• Experiences headache of any kind at a frequency greater than or equal to 15 days per month
• Chronic opioid therapy (\> 10 days in the 30 days prior to screening)
• Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization
• Hemiplegic or basilar migraine
• History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
• Uncontrolled hypertension (screening systolic/diastolic blood pressure \> 140/90 mmHg in 2 out of 3 readings)
• History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure
• History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria.
• Systemic disease, which in the opinion of the Investigator, would contraindicate participation
• History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation
• Pregnant or lactating women
• Have taken any investigational medication within 30 days before randomization, or are scheduled to receive an investigational drug
• Subjects with a positive urine drug screen for recreational drugs or marijuana (whether legal or not) or for prescription drugs not explained by stated concomitant medications
• Clinical laboratory or electrocardiogram (ECG) abnormality that in the opinion of the Investigator would endanger the subject or interfere with the study conduct. If the results of the clinical laboratory or ECG are outside of normal reference range the subject may still be enrolled but only if these findings are determined to be not clinically significant by the Investigator. This determination must be recorded in the subject's source document prior to enrolment.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Clinvest

Springfield, Missouri, 65807, United States

Location

Related Publications (1)

• Cady RK, Munjal S, Cady RJ, Manley HR, Brand-Schieber E. Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine. J Headache Pain. 2017 Dec;18(1):17. doi: 10.1186/s10194-016-0717-7. Epub 2017 Feb 7.

  PMID: 28176235 RESULT

MeSH Terms

Interventions

Sumatriptan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Development
• Organization: Dr. Reddy's

cfritz@drreddys.com

609-375-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 8, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 26, 2019
• Results First Posted: July 24, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)