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Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache (SOinCH)

Primary Purpose

Cluster Headache

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sodium Oxybate
Placebo
Sponsored by
Ramin Khatami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluster Headache

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Current diagnosis of cluster headache according to the criteria of International Headache Classification (ICHD-II, 2005) of the International Headache Society (IHS).
  2. Diagnosis of cluster headache has been made at least 6 weeks after start of screening
  3. Patients will have nocturnal pain attacks
  4. Duration since onset of current cluster episode at least 1 week
  5. Patients will have at least 1 attack per 48 hours and at least 4 attacks cumulatively by the time of visit 2 (prior to randomization)
  6. Disturbed sleep quality
  7. Patients have expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning protocol required procedures.
  8. Women must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control. Patients should agree to continue this method for the duration of the study and for one month after the discontinuation of SO treatment. Women should be negative to serum pregnancy test performed at the screening visit. Females should not be breastfeeding patient.
  9. In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests).
  10. If indicated by investigator, patient must be willing to not operate a car or heavy machinery for 6 hours after the last intake of the investigational drug during the duration of the trial or as long as the investigator deems clinically indicated. In addition, the patient should be willing to abstain during the study any alcohol consumption or behaviours which could interact with the investigational drug.

Exclusion Criteria:

  1. The use of sodium oxybate or any previous investigational drugs within 30-day period prior to initial screening visit (V1) for this trial.
  2. Change of prophylactic treatment 2 weeks prior of baseline visit 1
  3. Have sleep apnea syndrome, defined as an Apnea index > 10 per hour or an Apnea-hypopnea Index (AHI) > 15/h or an oxygen desaturation index (ODI) > 15/h
  4. Are taking hypnotics, tranquilizers, antihistamines (except for medication as defined in section 9.4.1. "authorized medication"), benzodiazepines at the start of the baseline period.
  5. Patients with psychiatric and neurological disorders, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical depression (BDI ≥ 16 with suicidal risk: item G BDI >0).
  6. Patients who are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol.
  7. Patients who are unable or unwilling to temporarily discontinue any unauthorized drugs or substances, in particular refrain from alcohol (see section non-authorized treatments).
  8. Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
  9. Patients taking anticonvulsants are not eligible to participate even if they are willing to washout anticonvulsants for the trial.
  10. Patients having other problems that, in the investigators opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms.
  11. Patients having a history of seizure disorder
  12. Patients having a severe renal impairment (e.g. serum creatine greater than 2.0 mg/dl), or a with severe hepatic impairment (abnormal liver function tests SGOT [AST] or SGPT [ALT] more than twice of the upper limit of normal) or elevated serum bilirubin (more than 1.5 times the upper limit of normal) or receiving anti-vitamin K substances.
  13. Any significant serious abnormality of the cardiovascular system e.g. recent myocardial infarction, angina, hypertension or dysrhythmias (within the prior 6 months), greater than a first degree AV block.

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sodium oxbate

    Placebo

    Arm Description

    oral administration of sodium oxybate, 6-18ml per night, starting with 6ml in two nightly dosages of 1.5g each, increased by steps of 1.5g every second or third night until treatment response

    oral administration of placebo, 6-18ml per night, starting with 6ml in two nightly dosages

    Outcomes

    Primary Outcome Measures

    nocturnal pain frequency as assessed by patients reports
    Reduction of nocturnal pain frequency as documented in patients diary,

    Secondary Outcome Measures

    Improvement of sleep quality
    Change assessed by PSQI (Pittsburgh Sleep Quality Inventory)
    pain free time as assessed by diary
    number and duration of pain free time periods compared to baseline
    Clinical Global Impression
    Change assessed by CGI-E scale
    Quality of life
    Assessed by SF 36
    Daytime Sleepiness
    Improvement as assessed by Epworth Sleepiness Score
    Escape medication
    Decrease in escape medication for acute headache attacks (use of triptans)
    Depression
    Change in Beck's depression inventory (BDI-II)
    Functional outcome of sleep quality
    Changes as assessed by questionaire of Functional Outcomes of Sleep Questionaire (FOSQ)

    Full Information

    First Posted
    December 9, 2015
    Last Updated
    December 18, 2015
    Sponsor
    Ramin Khatami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02637648
    Brief Title
    Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache
    Acronym
    SOinCH
    Official Title
    Safety and Efficacy of Sodium Oxybate in the Prophylaxis of Headache and Sleep Disturbances in Patients With Chronic and Episodic Cluster Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ramin Khatami

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to test the effects of sodium oxybate on headache response (frequency), sleep quality and quality of life in the prophylactic treatment of patients with chronic and episodic cluster headache. Oral sodium oxybate, 3-9g per night, starting with 3g in two nightly dosages of 1.5g and increased by steps of 1.5g every second or third night until treatment Response will be evaluated in an interventional, placebo-controlled, double-blind, randomised, parallel group, multicentre study. Primary outcome is reduction of nocturnal pain frequency Secondary outcomes are improvement of sleep quality at a subjective level as assessed by diary and standardized scales (PSQI, FOSQ), duration of pain free episodes, general clinical outcome (global evaluation), clinical global impression (CGI-S, CGI-I, CGI-E), quality of life (SF 36) and daytime sleepiness (Epworth Sleepiness Score).
    Detailed Description
    Multicenter study to test the safety and efficacy of sodium oxybate in the prophylaxis of headache and sleep disturbances in patients with chronic and episodic cluster headache using a placebo-controlled, double blind, randomized study, parallel group design. Patients with predominant nocturnal attacks and poor sleep quality will be evaluated; At least 1 attack every other day and at least 8 attacks cumulatively by the time prior to randomization are required. Sodium oxybate will be orally administered, 3-9g per night, starting with 3g in two nightly dosages of 1.5g (the first at bedtime and the second 4 hours later). Dosage will be gradually increased by steps of 1.5g every second night until treatment response during a titration period of 14 days. Effects od sodium oxybate will be monitored via pain and sleep diaries during a 14 days stable treatment phase by reviewing sleep/pain diaries and Quality of life assessement. Primary outcomes are frequency of nocturnal pain attacks; Main secondary outcomes are frequency, intensity and duration of daytime pain attacks, improvement of sleep quality, quality of life, duration and rates of pain free episodes, decrease in escape medication for acute headache attacks (use of triptans). Safety parameters are ECG, laboratory, depressions scales, vital signs, respiratory polygraphy. Intent-to treat analysis, multivariate analysis of variance (MANOVA) with depending variable (reduction of pain frequency and pain intensity of nocturnal attacks) and the co-variates (age, sex , chronic vs. episodic CH).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cluster Headache

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sodium oxbate
    Arm Type
    Experimental
    Arm Description
    oral administration of sodium oxybate, 6-18ml per night, starting with 6ml in two nightly dosages of 1.5g each, increased by steps of 1.5g every second or third night until treatment response
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    oral administration of placebo, 6-18ml per night, starting with 6ml in two nightly dosages
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Oxybate
    Other Intervention Name(s)
    Xyrem
    Intervention Description
    parallel Group administration
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    not speficied
    Intervention Description
    parallel Group administration
    Primary Outcome Measure Information:
    Title
    nocturnal pain frequency as assessed by patients reports
    Description
    Reduction of nocturnal pain frequency as documented in patients diary,
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Improvement of sleep quality
    Description
    Change assessed by PSQI (Pittsburgh Sleep Quality Inventory)
    Time Frame
    4 weeks
    Title
    pain free time as assessed by diary
    Description
    number and duration of pain free time periods compared to baseline
    Time Frame
    4 weeks
    Title
    Clinical Global Impression
    Description
    Change assessed by CGI-E scale
    Time Frame
    4 weeks
    Title
    Quality of life
    Description
    Assessed by SF 36
    Time Frame
    through study completion
    Title
    Daytime Sleepiness
    Description
    Improvement as assessed by Epworth Sleepiness Score
    Time Frame
    4 weeks
    Title
    Escape medication
    Description
    Decrease in escape medication for acute headache attacks (use of triptans)
    Time Frame
    4 weeks
    Title
    Depression
    Description
    Change in Beck's depression inventory (BDI-II)
    Time Frame
    4 weeks
    Title
    Functional outcome of sleep quality
    Description
    Changes as assessed by questionaire of Functional Outcomes of Sleep Questionaire (FOSQ)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Current diagnosis of cluster headache according to the criteria of International Headache Classification (ICHD-II, 2005) of the International Headache Society (IHS). Diagnosis of cluster headache has been made at least 6 weeks after start of screening Patients will have nocturnal pain attacks Duration since onset of current cluster episode at least 1 week Patients will have at least 1 attack per 48 hours and at least 4 attacks cumulatively by the time of visit 2 (prior to randomization) Disturbed sleep quality Patients have expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning protocol required procedures. Women must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control. Patients should agree to continue this method for the duration of the study and for one month after the discontinuation of SO treatment. Women should be negative to serum pregnancy test performed at the screening visit. Females should not be breastfeeding patient. In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests). If indicated by investigator, patient must be willing to not operate a car or heavy machinery for 6 hours after the last intake of the investigational drug during the duration of the trial or as long as the investigator deems clinically indicated. In addition, the patient should be willing to abstain during the study any alcohol consumption or behaviours which could interact with the investigational drug. Exclusion Criteria: The use of sodium oxybate or any previous investigational drugs within 30-day period prior to initial screening visit (V1) for this trial. Change of prophylactic treatment 2 weeks prior of baseline visit 1 Have sleep apnea syndrome, defined as an Apnea index > 10 per hour or an Apnea-hypopnea Index (AHI) > 15/h or an oxygen desaturation index (ODI) > 15/h Are taking hypnotics, tranquilizers, antihistamines (except for medication as defined in section 9.4.1. "authorized medication"), benzodiazepines at the start of the baseline period. Patients with psychiatric and neurological disorders, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical depression (BDI ≥ 16 with suicidal risk: item G BDI >0). Patients who are experiencing any major illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological, pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise the objectives outlined in the protocol. Patients who are unable or unwilling to temporarily discontinue any unauthorized drugs or substances, in particular refrain from alcohol (see section non-authorized treatments). Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Patients taking anticonvulsants are not eligible to participate even if they are willing to washout anticonvulsants for the trial. Patients having other problems that, in the investigators opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms. Patients having a history of seizure disorder Patients having a severe renal impairment (e.g. serum creatine greater than 2.0 mg/dl), or a with severe hepatic impairment (abnormal liver function tests SGOT [AST] or SGPT [ALT] more than twice of the upper limit of normal) or elevated serum bilirubin (more than 1.5 times the upper limit of normal) or receiving anti-vitamin K substances. Any significant serious abnormality of the cardiovascular system e.g. recent myocardial infarction, angina, hypertension or dysrhythmias (within the prior 6 months), greater than a first degree AV block. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ramin Khatami, MD
    Phone
    +41 62 857 2220
    Email
    ramin.khatami@barmelweid.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sabine Studer
    Phone
    +41 62 857 2228
    Email
    sabine.studer@barmelweid.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ramin Khatami, MD
    Organizational Affiliation
    Clinic Barmelweid AG
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21613599
    Citation
    Khatami R, Tartarotti S, Siccoli MM, Bassetti CL, Sandor PS. Long-term efficacy of sodium oxybate in 4 patients with chronic cluster headache. Neurology. 2011 Jul 5;77(1):67-70. doi: 10.1212/WNL.0b013e31822313c6. Epub 2011 May 25.
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    Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

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