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Pilot Study of DFN-11 Injection in Medication Overuse Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02583425
Recruitment Status : Terminated
First Posted : October 22, 2015
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache

Condition or disease Intervention/treatment Phase
Medication Overuse Headache Drug: DFN-11 Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DFN-11
DFN-11 Injection upon occurrence of migraine
Drug: DFN-11 Injection



Primary Outcome Measures :
  1. The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) [ Time Frame: 28 days Baseline period and 28 days of Treatment period (Total 56 days) ]

Secondary Outcome Measures :
  1. The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) [ Time Frame: 28 days Baseline period and 28 days of Treatment period (Total 56 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of medication overuse headache within the past year in the following categories
  2. Diagnosis of migraine, with or without aura for at least 12 months
  3. Experience an average of > 10 headache days per month for the past 12 months
  4. Females must:

    i. 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 willing to continue throughout the study, or ii. be surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or iii. be postmenopausal (spontaneous amenorrhea for at least 1 year)

  5. Females of child-bearing potential must have a negative urine pregnancy test at all visits.
  6. Able and willing to read and comprehend written instructions and complete the electronic diary.
  7. Must have internet access to complete daily headache diary.

Exclusion Criteria:

  1. Current use of medication for headache/migraine prophylaxis that has not been stable for 30 days prior to screening. Stable is defined as no recent dosing change within 30 days of screening.
  2. Hemiplegic or basilar migraine
  3. History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
  4. Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings)
  5. Clinically significant hepatic impairment
  6. History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure
  7. History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria
  8. Systemic disease, which in the opinion of the Investigator, would contraindicate participation
  9. History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation
  10. Pregnant or lactating women
  11. Have taken any investigational medication within 30 days before screening, or are scheduled to receive an investigational drug
  12. 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
  13. 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.
  14. Fridericia's corrected QT (QTcF) interval greater than 450 msec
  15. Severe renal impairment (creatinine > 2 mg/dl)
  16. Serum total bilirubin > 2.0 mg/dL
  17. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal
  18. Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin
  19. Subjects who in the opinion of the investigator experience rebound headache from caffeine usage

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): NCT02583425


Locations
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United States, Missouri
Clinvest
Springfield, Missouri, United States, 65807
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02583425    
Other Study ID Numbers: DFN-11-CD-007
First Posted: October 22, 2015    Key Record Dates
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Headache Disorders, Secondary
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases