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Sleep ApneaPhase 2NCT01765608

Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients

A Phase 2 study testing Zonisamide and nCPAP in people with Sleep Apnea and Obstructive Sleep Apnea, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with moderate to severe obstructive sleep apnea. Patients will be randomized to receive zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Sleep Apnea, Obstructive Sleep Apnea, Obesity
What is being tested?
Zonisamide and nCPAP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteSweden
Study dates
Mar 2010to Jun 2013
Phase
Phase 2
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

  • Provision of informed consent prior to any study specific procedures
  • Males/females 18 to 75 years
  • An Apnea-Hypopnea Index (AHI)>15
  • Epworth Sleepiness Scale score (ESS)>6
  • Body mass index (BMI) between >27 and <35 kg/m2 (mild to moderate)
  • Clinically normal physical findings and laboratory values, as judged by the investigator

Who cannot join

  • Hypersensitivity to sulfonamides or zonisamide.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
  • Subjects with a seizure disorder
  • Clinically significant renal (serum creatinine >2.0 mg/dL or >130 µmol/L), neurological, metabolic (e.g. Type 1 or 2 diabetes), haematological or hepatic disease (ASAT or ALAT >2 times the upper limit of normal).
  • Subjects who have taken any weight loss medications (prescription or over-the-counter) within one month prior to Enrollment
  • Subjects with occupations designated as high risk or safety sensitive including patients who have to handle complex machinery or are professional drivers where there may be an increased risk for work or traffic accidents.
Show all 21Show fewer
  • Unstable angina pectoris
  • Unstable hypertension (diastolic blood pressure above 100 on treatment for more than 3 months), diabetes (fasting plasma glucose above 7 mmoles/l)
  • Uncontrolled congestive heart failure
  • Myocardial infarction or coronary vessel intervention within the previous 6 months period
  • Subjects with uncontrolled hypertension (defined as a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥180 mmHg with or without medication). Hypertensive subjects on medications must have been on the same dose of the same antihypertensive medication for at least two months prior to Enrollment.
  • Previously diagnosed or treated clinically significant cardiac arrhythmia
  • Clinically significant chronic pulmonary or gastrointestinal disease
  • Clinical history of depression as judged by the investigator or other previous or present clinically significant psychiatric disease
  • Pregnancy or lactation. Women of childbearing potential should use effective birth control prior to and during the study
  • Suspected or confirmed poor compliance
  • Alcohol or drug abuse during the last year
  • Subjects with any other significant condition that, in the opinion of the investigator, could interfere with participation in the study.
  • Severe nocturnal hypoxia defined as more than 10 episodes with an oxygen desaturation exceeding 50% or signs of lacking resaturation between desaturations on previous recordings according to investigators judgement.
  • Participation in another clinical study during the last 6 months
  • Inability to understand and complete the questionnaires

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Center for Sleep and Vigilance Disorders

    Gothenburg, Västra Götaland County, 40530

Other trials in Sweden

About this study

Official title: A 1 Month Randomized Placebo Controlled, Double Blind Trial With a 5 Month Open Extension Phase to Explore the Efficacy of Zonisamide on Apnea/Hypopnea Index in Overweight/Obese Sleep Apnea Patients.

This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with moderate to severe obstructive sleep apnea. Patients will be randomized to receive zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5 month open extension part will follow when patients in the tablet groups will all receive zonisamide. Patients in the open CPAP group will continue with CPAP treatment.

Study hypothesis:

Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is hypothesized that zonisamide has a direct pharmacological effect on respiratory control during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction of sleep disordered breathing.

Being tested
Zonisamide, Placebo, nCPAP
Keywords
Zonisamide, Zonegran, Obstructive Sleep apnea, Apnea, Respiration Disorders, Sleep Disorders, Obesity, Anti-Obesity Agents, Carbonic Anhydrase, Carbonic Anhydrase Inhibitors, Enzyme Inhibitors, Sulfonamides, Therapeutic Uses, Pharmacologic Actions
Medical subject headings
Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Obesity, Apnea, Respiration Disorders, Sleep Wake Disorders

What participants receive

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

  • ZonisamideDrug

    Also called Zonegran®

    Zonisamide (Zonegran®) tablets will be administered according to a forced stepwise weekly titration scheme with weekly 100 mg escalations from 100 to 300 mg daily according to the manufacturer Eisai Inc.

  • PlaceboDrug

  • nCPAPDevice

    Also called nCPAP - Nasal Continuous Positive Airway Pressure., ResMed - S9 AutoSet™, ResMed - S8 AutoSet Spirit™ II

Study groups in NCT01765608
Study groupRoleWhat they receive
ZonisamideExperimentalZonisamide (Zonegran®) 300 mg. Hard white capsule. The total length of zonisamide treatment will be 20 and 24 weeks ± 2 weeks including one or two 4 week titration phases in the placebo and zonisamide groups respectively. Dosing will be down titrated after finished study during 2-3 weeks.The maximum dose after titration will be administrated once daily. Evening medication should be taken 2 hours before bedtime. The tablets will be swallowed with 200 ml of water (room temperature) in an upright body position.
Receives: Drug: Zonisamide
PlaceboActive comparatorMatched for Zonisamide. Hard white capsule. Manufactured by Eisai Inc. Placebo tablets will be administered according to a forced stepwise weekly titration scheme with weekly 1 tablet escalations from 1 to 3 tablets daily matching the Zonisamide (Zonegran ®) dosing regimen for a total duration of 4 weeks. Evening medication should be taken 2 hours before bedtime. The tablets will be swallowed with 200 ml of water (room temperature) in an upright body position.
Receives: Drug: Placebo
nCPAPActive comparatorContinuous positive nasal airway pressure (nCPAP) delivers slightly pressurized air throughout the breathing cycle and will be given through a mask that is placed and secured over the person's nose. nCPAP titration will follow clinical routines whereby the patient is equipped with an autotitrating device (Sullivan S8 or S9). The standard setting is a pressure delivery in the pressure range 5-15 mbar and the full treatment is maintained in the patient´s home. The adequate performance of the device is controlled by user time readers and built-in memory cards and control readings are routinely performed within the first 4 weeks of treatment initiation. Patients will be encouraged via telephone calls for maximum use. Total duration of CPAP treatment is 24 weeks.
Receives: Device: nCPAP

What is being measured

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

  1. Primary objective is to investigate the effect of zonisamide vs. placebo on sleep disordered breathing after short-term (4 weeks) treatment.

    The primary objective of this study is to explore the efficacy of pharmacological weight reduction on obstructive sleep apnea (OSA) by assessment of apnoea/hypopnea index (AHI) and oxygen desaturation index (ODI) 4 weeks .

    Measured: Baseline to 4 weeks.

Secondary outcomes (2)

  1. Longterm efficacy and effect of zonisamide on obstructive sleep apnea (OSA)in comparison to CPAP by assessment of apnoea/hypopnea index (AHI) after 24 weeks.

    The effect of CPAP will be expressed in terms of apnea alleviation. Other secondary objectives include the effect on oxygen desaturation, mean overnight oxygenation, sleep quality (by polysomnographic assessment), daytime sleepiness, daytime cognitive function, patient-reported outcomes, blood pressure and effects on metabolic markers.

    Measured: baseline to 24 weeks

  2. Secondary objective is to investigate the effect of zonisamide vs. placebo on other sleep disordered breathing parameters after short-term (4 weeks) treatment.

    Secondary objectives include the effect on other markers of sleep apnea like mean overnight oxygenation, sleep quality (by polysomnographic assessment), daytime sleepiness, daytime cognitive function, patient-reported outcomes, blood pressure and effects on metabolic markers after short term treatment (4 weeks).

    Measured: Baseline to 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 posted10 Jan 2013 (estimated)
  2. Study startMar 2010
  3. Primary completionJun 2013
  4. Study completionJun 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01765608
Sponsor's protocol ID
ZON-01
Other IDs
2009-015859-24, 2009
Status last verified
Feb 2014
First submitted
8 Jan 2013
Last updated
20 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zonisamide and nCPAP in people with Sleep Apnea and Obstructive Sleep Apnea, run by Göteborg University at 1 site in Sweden.

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 6 inclusion and 21 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: finished, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary objective is to investigate the effect of zonisamide vs. placebo on sleep disordered breathing after short-term (4 weeks) treatment. (time frame: Baseline to 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 NCT01765608.

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 20 Feb 2014.

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