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New treatment option for Central Auditory Processing Disorder
Official title A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
ClinicalTrials.gov ID: NCT07304024
What this study is testing
What is Clemastine Fumarate Combined With Engineered Sound?
Clemastine Fumarate Combined With Engineered Sound is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for central auditory processing disorder.
Also referred to as Localized Oligodendrocyte Optimization Therapy, LOOT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to determine the efficacy of Clemastine Fumarate in the presence of engineered sound to treat age-related central auditory processing disorder (CAPD). This disorder impacts 800M patients worldwide, including \~1/3 people over 40 years of age and \~1/2 people over 65, resulting in an inability to hear in noisy environments.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65
You may be able to join if
- Male or female between 45 and 65 years old (middle aged) at the screening/enrollment visit (Visit 1).
- Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
- Documentation of no more than a mild high-frequency hearing sensitivity loss and normal middle-ear function will be obtained using standard...
- bilateral hearing thresholds \ 10 dB.
- symmetrical hearing thresholds between the ears through 8000 Hz, defined as \<20 dB difference at any single audiometric frequency or \< 15 dB...
You likely can't join if
- Any people who do not fall under the criteria defined above.
- Any of the following conditions which are listed as contraindications or warnings for use of the clinical trial drug (from labeling):
- Known sensitivity to clemastine fumarate or other antihistamines of similar composition
- Pregnancy or nursing mother as determined objectively with a urine pregnancy test
- Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis
- Glaucoma or increased intraocular pressure
See the full eligibility criteria
- Male or female between 45 and 65 years old (middle aged) at the screening/enrollment visit (Visit 1).
- Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
- Documentation of no more than a mild high-frequency hearing sensitivity loss and normal middle-ear function will be obtained using standard audiometric equipment with measurements done by an audiologist; Specifically...
- bilateral hearing thresholds \ 10 dB.
- symmetrical hearing thresholds between the ears through 8000 Hz, defined as \<20 dB difference at any single audiometric frequency or \< 15 dB difference at 2 or more contiguous frequencies.
- normal (Type A) tympanograms bilaterally.
- No cognitive deficit shown upon screening with the Montreal Cognitive Assessment (MOCA) test (Nasreddine et al. 2005).
- Distortion product otoacoustic emission (DPOAE) showing no more than 20 dB hearing loss at audiometric frequencies from 250 Hz to 4000 Hz.
- people failing the hearing in noise test at 15 degrees. Failing is defined as SNR being 12 dB below from what is found in normal hearing people without central hearing loss.
- Any people who do not fall under the criteria defined above.
- Any of the following conditions which are listed as contraindications or warnings for use of the clinical trial drug (from labeling):
- Known sensitivity to clemastine fumarate or other antihistamines of similar composition
- Pregnancy or nursing mother as determined objectively with a urine pregnancy test
- Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis
- Glaucoma or increased intraocular pressure
- Stenosing peptic ulcers or pyloroduodenal obstruction
- Trouble urinating due to an enlarged prostate gland. Mild urinary issues (Stage 1 Benign Prostatic Hyperplasia) will not be considered an automatic exclusion but it must be emphasized to patients with this diagnosis...
- Significant cardiovascular disease, chronic hypertension or hypotension
- Hyperthyroidism
- Alcoholism- as defined by consuming on average 3+ drinks per day for women or 4+ drinks per day for men or previous diagnosis of alcohol use disorder by a clinician as defined by DSM V criteria.
- Patients with a history of seizures will be excluded.
- Patients with evidence of suicidal ideation/behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
- We will generally exclude people with significant or uncontrolled medical disorders (e.g., hepatic, hematologic, renal, gastrointestinal, neurological, psychiatric disorders). We will define these patients as those who...
- Leukopenia as defined as a CBC white blood cell count \< 4000/ul
- Anemia as defined by a CBC Hemoglobin \<9.0 g/dL or \<10.0 g/dL (Grade 2+ CTCAE)
- Lymphopenia as defined by CBC Absolute lymphocyte count \<1000/µL.
- Neutropenia as defined by CBC ANC \<1500/µL (solid tumors), ANC \<1000/µL (hematologic malignancies). In the case of participants with African, Middle Eastern or West Indian descent a clinician's judgement will be...
- Thrombocytopenia as defined by CBC Platelet count \<75000/µL
- Hepatic Impairment based on CMP: Total bilirubin \>1.5× ULN, AST/ALT \>3× ULN (or \>5× ULN if liver metastases), Alkaline phosphatase \>3× ULN.
- Hepatic Impairment based on CMP: Serum creatinine \>2.0 mg/dL (alternative threshold).
- Metabolic abnormalities based on CMP: Albumin \<3.0 g/dL
- Taking medications that would contraindicate taking the clinical trial drug; Specifically, (from labeling):
- Monoamine oxidase inhibitor therapy
- CNS depressants (sedatives, tranquilizers, hypnotics)
- A history of significant otologic disorder such as repetitive ear infections or Meniere's disease
- A history of significant neurologic disorder, or current neurodegenerative diseases such as multiple sclerosis, which could present a confound and impact the electrophysiological outcome measures.
- A history of traumatic brain or closed head injury because this can cause symptoms of central auditory processing problems unrelated to aging and demyelination.
- English as a second language (non-native English speakers), which is known to negatively impact scores on speech recognition testing.
- Presence of any other condition or abnormality that in the opinion of the Investigator or his co-PIs would compromise the safety of the patient or the quality of the data.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.