Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

NCT02637648 | Unknown Phase 3 DMC

• 1 other identifier: BWSO0812
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

• nocturnal pain frequency as assessed by patients reports

  Reduction of nocturnal pain frequency as documented in patients diary,

  4 weeks

Secondary Outcomes (8)

• Improvement of sleep quality

  4 weeks

• pain free time as assessed by diary

  4 weeks

• Clinical Global Impression

  4 weeks

• Quality of life

  through study completion

• Daytime Sleepiness

  4 weeks

Study Arms (2)

Sodium oxbate

EXPERIMENTAL

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

Drug: Sodium Oxybate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sodium Oxybate DRUG

parallel Group administration

Also known as: Xyrem

Sodium oxbate

Placebo DRUG

parallel Group administration

Also known as: not speficied

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramin Khatami: lead

Related Publications (1)

• 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.

  PMID: 21613599 BACKGROUND

MeSH Terms

Conditions

Cluster Headache

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Ramin Khatami, MD

  Clinic Barmelweid AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramin Khatami, MD

CONTACT

+41 62 857 2220; ramin.khatami@barmelweid.ch

Sabine Studer

CONTACT

+41 62 857 2228; sabine.studer@barmelweid.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associative professor

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 22, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2017
• Last Updated: December 22, 2015

Record last verified: 2015-12