Solriamfetol*s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (SHARP): a 5-Week Double-blind, Placebo-controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function.
- Conditions
- Excessive Daytime SleepinessSleep Apnea10040998
- Registration Number
- NL-OMON50853
- Lead Sponsor
- Jazz Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Age and Sex
1. Male or female between 18 (or the legal age of consent in the
jurisdiction in which the study takes place) and 65 years of age,
inclusive.
Type of Participant and Disease Characteristics
2. Diagnosis of OSA according to International Classification of Sleep
Disorders, Third Edition criteria.
3. Participant report (with clinician concurrence) of at least 1 of the
following primary OSA therapy criteria:
• Consistent number of hours of primary PAP therapy use (with
downloadable history) for OSA on at least 5 nights/week for at least 1
month prior to Baseline (with or without prior OSA surgical
intervention), OR
• No current use of PAP therapy for at least 1 month prior to Baseline
but a history of at least 1 month of attempting to use PAP as the primary
OSA therapy with at least 1 documented adjustment that was made in an
attempt to optimize the therapy (with or without prior OSA surgical
intervention), OR
• History of a surgical intervention intended to treat OSA symptoms
(with or without current PAP use as primary OSA therapy).
4. The participant has an age-corrected scaled score <= 8 on the DSST
Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) at the
Screening visit.
5. British Columbia-Cognitive Complaints Inventory >= 9 at Screening and
Baseline.
6. Epworth Sleepiness Scale (ESS) score > 10 at Screening and Baseline.
7. Usual nightly total sleep time of >= 6 hours.
Weight
8. Body mass index from 18.5 to < 40 kg/m2.
Sex and Contraceptive/Barrier Requirements
9. Male and female Participants
a. Male participants:
Male participants are eligible to participate if they agree to the following
during the study intervention period and for at least 14 days after the
last dose of study intervention:
• Refrain from donating sperm
PLUS, either:
• Be abstinent from heterosexual intercourse as their preferred and
usual lifestyle (abstinent on a long-term and persistent basis) and agree
to remain abstinent
OR
• Must agree to use contraception/barrier as detailed below
• Agree to use a male condom with female partner use of an additional
highly effective contraceptive method with a failure rate of < 1% per
year as described in Appendix 5 Contraceptive and Barrier Requirements
when having sexual intercourse with a women of childbearing potential
(WOCBP) who is not currently pregnant.
b. Female participants:
• A female participant is eligible to participate if she is not pregnant or
breastfeeding, and 1 of the following conditions applies:
* Is a woman of nonchildbearing potential (WONCBP) as defined in
Appendix 5 Contraceptive and Barrier Guidance
OR
* Is a WOCBP and using a contraceptive method that is highly effective
(with a failure rate of < 1% per year), as described in 0 Contraceptive
and Barrier Guidance during the study intervention period and for at
least 14 days after the last dose of study intervention. The investigator
should evaluate the potential for contraceptive method failure (eg,
noncompliance, recently initiated) in relationship to the first dose of
study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (urine
or serum as required by local regulations) within the Screening/Baseline
period (once at the time of Screening for participation in the study and
again at the time of the study Baseline
1. Female participants who are pregnant, nursing, or lactating.
2. Usual bedtime later than 1 AM (0100 hours).
3. Occupation requiring nighttime or variable shift work.
4. Unable to understand or perform DSST test per investigator's
judgement.
6. Diagnosis of another sleep disorder (other than OSA) including:
circadian rhythm sleep disorders, narcolepsy, restless legs syndrome
determined by participant sleep history.
7. Presence of acutely unstable major depression or current major
depressive episode as based on the judgement of the investigator.
8. Participants with active clinically significant illness, including
endocrine, neoplastic, gastrointestinal, hematological, hepatic,
immunologic, metabolic, neurological, pulmonary, and/or renal disease,
and/or surgical history which could interfere with the study efficacy,
safety, conduct or the ability of the participant to complete the study
based on the judgement of the investigator, or place the participant at
risk during the trial or compromise the study objectives.
9. History or presence of any other clinically relevant medical,
behavioral, or psychiatric disorder other than OSA that is associated with
an impact on cognitive function; including history or presence of
neurodegenerative condition (eg, mild cognitive impairment due to
Alzheimer's), autism, vascular dementia, active suicidal ideation, that
could affect the safety of the participant or interfere with study efficacy,
safety, conduct or the ability of the participant to complete the trial
based on the judgment of the investigator.
10. History or presence of bipolar disorder, bipolar related disorders,
schizophrenia, schizophrenia spectrum disorders, or other psychotic
disorders according to Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition (DSM-5) criteria.
11. History of bariatric surgery within the past year or a history of any
gastric bypass procedure.
13. Presence of renal impairment or calculated creatinine clearance < 60
mL/minute.
14. Clinically significant ECG abnormality in the opinion of the
investigator.
15. Presence of significant cardiovascular disease including but not
limited to: myocardial infarction within the past year, unstable angina
pectoris, symptomatic congestive heart failure (ACC/American Heart
Association stage C or D), revascularization procedures within the past
year, uncontrolled atrial fibrillation, ventricular cardiac arrhythmias
requiring automatic implantable cardioverter defibrillator or medication
therapy, uncontrolled hypertension (as defined by Centers for Disease
Control and Prevention), systolic blood pressure >= 155 mmHg or
diastolic blood pressure >= 95 mmHg (at Screening or Baseline), or any
history of cardiovascular disease or any significant cardiovascular
condition that in the investigator's opinion may jeopardize participant
safety in the study.
16. Laboratory value(s) outside the laboratory reference range that is
considered to be clinically significant by the investigator (clinical
chemistry, hematology, and urinalysis). NOTE: Screening labs may be
repeated once.
17. Hypothyroidism or hyperthyroidism, unless stabilized by appropriate
medication for at least 3 months prior to Screening (a normal thyroidstimulating
hormone is required prior to Randomization at Baseline).
Prior/Concomitant Therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in DSST means from the average of the 2- and 4-hour scores at<br /><br>Baseline (Visit 3) to the average of the 2- and 4-hour postdose scores<br /><br>(at Visit 5 and Visit 8) between solriamfetol and placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Difference in overall BC-CCI score means from Baseline (Visit 3) to the end<br /><br>of double-blind treatment period (Visit 5 and Visit 8) between<br /><br>solriamfetol and placebo<br /><br><br /><br>2.<br /><br>- Difference in DSST means from the average of the 2-, 4-, 6-, and 8-hour<br /><br>scores at Baseline (Visit 3) to the average of 2-, 4-, 6-,<br /><br>and 8-hour scores postdose (at Visit 5 and Visit 8) between solriamfetol and<br /><br>placebo<br /><br>- Difference in DSST means from each of the 2-, 4-, 6-, and 8- hour DSST RBANS<br /><br>sores at Baseline (Visit 3) to each of the corresponding 2-, 4-, 6-, and 8-hour<br /><br>postdose (at Visit 5 and Visit 8) DSST RBANS scores between solriamfetol and<br /><br>placebo<br /><br><br /><br>3. Safety and tolerability evaluations will be determined by the occurrence of<br /><br>and/or changes in:<br /><br>• Incidence and severity of TEAEs<br /><br>• Vital signs<br /><br>• C-SSRS</p><br>