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Staccato Loxapine in Migraine (in Clinic)

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: NCT00489476
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : April 24, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 20, 2007
First Posted Date  ICMJE June 21, 2007
Results First Submitted Date  ICMJE March 13, 2017
Results First Posted Date  ICMJE April 24, 2017
Last Update Posted Date July 6, 2017
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Pain-relief Response (Pain Severity of NONE or MILD) at 2 Hours [ Time Frame: Baseline and 2 h post-dose ]
The primary efficacy endpoint was Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD. Intent to treat (ITT) with last observation carried forward (LOCF)
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
The primary efficacy endpoint will be Pain-relief response as defined by the International Headache Society (Pain-IHS) as a pain severity of NONE or MILD. [ Time Frame: 2 h post-dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Pain-free at 2 Hours [ Time Frame: Baseline and 2 h post-dose ]
Pain-free (Pain-IHS) at the 2 hour time point
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2007)
Pain-free and pain-IHS at the time of Symptom assessment (presence or absence) of nausea, vomiting, photophobia, and phonophobia at the other time-points. [ Time Frame: 24 hr ]
Current Other Pre-specified Outcome Measures
 (submitted: June 13, 2017)
Responders, Sustained Freedom From Pain [ Time Frame: Baseline through 24 h post-dose ]
The percentages of patients with sustained freedom from pain (pain-free at 2 hours after dosing with no rescue medication and no recurrence of headache from 2 to 24 hours)
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Staccato Loxapine in Migraine (in Clinic)
Official Title  ICMJE A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Single Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Patients With Migraine Headache
Brief Summary The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.
Detailed Description This study will enroll male and female patients with migraine headache with or without aura. The study will randomize ~160 patients, 1:1:1:1 to receive one of the following treatments: 1.25 mg Staccato Loxapine; 2.5 mg Staccato Loxapine; 5 mg Staccato Loxapine; Staccato Placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Staccato Loxapine
    Other Name: ADASUVE
  • Drug: Staccato Placebo
    Placebo aerosol inhalation (0mg)
Study Arms  ICMJE
  • Experimental: 1.25 mg Staccato Loxapine
    1.25 mg ADASUVE, single dose
    Intervention: Drug: Staccato Loxapine
  • Experimental: 2.5 mg Staccato Loxapine
    2.5 mg ADASUVE, single dose
    Intervention: Drug: Staccato Loxapine
  • Experimental: 5 mg Staccato Loxapine
    5 mg ADASUVE, single dose
    Intervention: Drug: Staccato Loxapine
  • Experimental: Staccato Placebo
    Staccato Placebo, 0 mg
    Intervention: Drug: Staccato Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2017)
168
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2007)
160
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female patients between the ages of 18 to 65 years, inclusive.
  2. Patients who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months.
  3. Patients who have a history of migraine and have had at least 3 migraine attacks in the last 3 month period (but not more than 8 migraine attacks in the last month).
  4. Patients who have been pain free for at least 48 hours since the end of their last migraine attack.
  5. Patients who have not taken any acute migraine or pain medication within 48 hours prior to dosing (including OTC products).
  6. Patients who have a pain rating of Moderate or Severe (on a None-Mild- Moderate-Severe Scale) prior to dosing.
  7. Patients who speak, read, and understand English and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures.
  8. Patients who are willing and able to comply with the study schedule and requirements, are willing and able to travel to the Clinical Research Unit (CRU) for treatment and stay at the CRU for approximately a 4-6 hour period, and agree to return to the clinic within 5 working days of use of the investigational treatment.
  9. Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
  10. Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone.

Exclusion Criteria:

  1. Patients who are currently taking antipsychotics, tricyclic antidepressants, valproate, barbiturates, benzodiazepines, or lithium must be excluded.
  2. Patients with a history of contraindications to anticholinergics (bowel obstruction, urinary retention, acute glaucoma) must be excluded.
  3. Patients with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
  4. Patients with a history of extra-pyramidal disorders, movement disorders including Parkinson's disease, and patients with a history of neuroleptic malignant syndrome must be excluded.
  5. Female patients who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded.
  6. Patients who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
  7. Patients who have a history of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma must be excluded.
  8. Patients who have a history of a major neurological disorder other than migraine (seizure disorder, subarachnoid bleeding, stroke, brain tumor) must be excluded.
  9. Patients who have any other disease(s), by history, physical examination, or laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, Bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion, would present undue risk to the patient or may confound the interpretation of study results must be excluded.
  10. Patients who have a history of asthma or chronic obstructive lung disease should be excluded.
  11. Patients who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
  12. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00489476
Other Study ID Numbers  ICMJE AMDC-104-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Responsible Party Alexza Pharmaceuticals, Inc.
Study Sponsor  ICMJE Alexza Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Egilius Spierings, MD MedVadis Research Corporation
PRS Account Alexza Pharmaceuticals, Inc.
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP