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Cluster HeadachePhase 3SOinCHNCT02637648

Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

A Phase 3 study testing Sodium Oxybate in people with Cluster Headache, run by Ramin Khatami.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cluster Headache
What is being tested?
Sodium Oxybate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
Dec 2015to Jun 2017
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • -

Trial locations and contacts

No sites are listed yet.

Ramin Khatami, MD contact

+41 62 857 2220

ramin.khatami@barmelweid.ch

Sabine Studer contact

+41 62 857 2228

sabine.studer@barmelweid.ch

About this study

Official title: Safety and Efficacy of Sodium Oxybate in the Prophylaxis of Headache and Sleep Disturbances in Patients With Chronic and Episodic Cluster Headache

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).

Read the 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).

Being tested
Sodium Oxybate, Placebo
Medical subject headings
Cluster Headache

What participants receive

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

  • Sodium OxybateDrug

    Also called Xyrem

    parallel Group administration

  • PlaceboDrug

    Also called not speficied

    parallel Group administration

Study groups in NCT02637648
Study groupRoleWhat they receive
Sodium oxbateExperimentaloral 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
Receives: Drug: Sodium Oxybate
PlaceboPlacebo comparatororal administration of placebo, 6-18ml per night, starting with 6ml in two nightly dosages
Receives: Drug: Placebo

What is being measured

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

  1. nocturnal pain frequency as assessed by patients reports

    Reduction of nocturnal pain frequency as documented in patients diary,

    Measured: 4 weeks

Secondary outcomes (8)

  1. Improvement of sleep quality

    Change assessed by PSQI (Pittsburgh Sleep Quality Inventory)

    Measured: 4 weeks

  2. pain free time as assessed by diary

    number and duration of pain free time periods compared to baseline

    Measured: 4 weeks

  3. Clinical Global Impression

    Change assessed by CGI-E scale

    Measured: 4 weeks

  4. Quality of life

    Assessed by SF 36

    Measured: through study completion

  5. Daytime Sleepiness

    Improvement as assessed by Epworth Sleepiness Score

    Measured: 4 weeks

  6. Escape medication

    Decrease in escape medication for acute headache attacks (use of triptans)

    Measured: 4 weeks

  7. Depression

    Change in Beck's depression inventory (BDI-II)

    Measured: 4 weeks

  8. Functional outcome of sleep quality

    Changes as assessed by questionaire of Functional Outcomes of Sleep Questionaire (FOSQ)

    Measured: 4 weeks

Timeline

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

  1. First posted22 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionSep 2016 (estimated)
  4. Study completionJun 2017 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02637648
Sponsor's protocol ID
BWSO0812
Acronym
SOinCH
Status last verified
Dec 2015
First submitted
9 Dec 2015
Last updated
22 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21613599

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium Oxybate in people with Cluster Headache, run by Ramin Khatami.

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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ramin Khatami, MD (+41 62 857 2220, ramin.khatami@barmelweid.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nocturnal pain frequency as assessed by patients reports (time frame: 4 weeks). 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 NCT02637648, which also lists 1 linked publication.

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 22 Dec 2015.

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