Dysautonomia of AdolescencePhase 2ADAPTNCT07881302
Effect of Ivabradine on Adolescent Dysautonomia
A Phase 2 study testing Ivabradine in people with Dysautonomia of Adolescence, run by Kathryn Armstrong at 1 site in Canada.
Trial summary
Dysautonomia of Adolescence (dysautonomia) is an umbrella term used to describe symptoms experienced by adolescents and young adults related to dysfunction of the autonomic nervous system. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Dysautonomia of Adolescence
- What is being tested?
- Ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2026to May 2028
- Phase
- Phase 2
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of dysautonomia of adolescence from the Dysautonomia Clinic in the Children's Heart Centre at BC Children's Hospital.
Who cannot join
- Patients who plan on becoming pregnant or who are pregnant.
- Nursing mothers.
- Patients with impaired kidney or liver function (based off last blood test within the past year if either is present consult the patient's nephrologist or hepatologist to determine risk of participation).
- Patients with a diagnosis of long QT.
- Patients on the following strong CYP3A4 inhibitors: Ketoconazole, Josamycin, Itraconazole, Clarithromycin, Nefazodone, Ritonavir, Atazanavir, Nelfinavir.
- Patients on the following moderate CYP3A4 inhibitors: Diltiazem, Verapamil, Fluconazole.
- Patients on the following CYP3A4 inducers: Rifampicin, Barbiturates, and Phenytoin.
- Patients on any QT prolongating agents such as antiarrhythmics, antipsychotics, antidepressants, opioids, antibiotics, antimalarials, antifungals, 5-HT3 receptor antagonists, tyrosine kinase inhibitors, histone deacetylase inhibitors, beta-2 adrenoreceptor agonists and drugs such as domperidone, pentamidine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melanie Kardel contact
About this study
Official title: A Series of N-of-1 Randomized Controlled Trials of Ivabradine for Improving Symptom Management in Adolescent Patients With Dysautonomia.
Dysautonomia of Adolescence (dysautonomia) is an umbrella term used to describe symptoms experienced by adolescents and young adults related to dysfunction of the autonomic nervous system. Symptoms can include dizziness, fatigue, increased heart rate upon standing, exercise intolerance, and difficulty with daily activities. Treatment commonly involves lifestyle modifications, including increased fluid and salt intake and structured routines related to diet, sleep, aerobic exercise, and lower-body strength training. While these approaches can be effective, some patients experience symptoms that make it difficult to implement these changes.
Despite increasing awareness of dysautonomia, research evaluating effective treatment strategies in adolescents remains limited, and there are currently no medications approved by Health Canada specifically for the treatment of dysautonomia. Ivabradine is a heart rate-lowering medication approved for the treatment of heart failure and has been studied as a potential treatment for symptoms associated with dysautonomia, including postural orthostatic tachycardia syndrome (POTS). However, there is limited evidence regarding its use in adolescents.
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate whether ivabradine can reduce symptom burden and improve heart rate control and overall well-being in adolescents with dysautonomia. The study will use a series of N-of-1 randomized controlled trials in which participants receive both ivabradine and placebo during different treatment periods. This design will allow the effects of ivabradine and placebo to be compared within individual participants.
Read the detailed description
Each N-of-1 trial will consist of two drug cycles of ivabradine/placebo or placebo/ivabradine with a 1-week washout period in between. Each participant will be randomized to treatment arms independently prior to the start of drug cycles 1 and 2 so that they may receive the treatments in either order during each drug cycle. Treatment overview:
Randomization cycle 1 a) Ivabradine - washout - Placebo or b) Placebo - washout - Ivabradine Cycle 1 washout Randomization cycle 2
- Ivabradine - washout - Placebo or b) Placebo - washout - Ivabradine
- Conditions
- Dysautonomia of Adolescence
- Being tested
- Ivabradine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Participants will initially receive 2.5 mg of ivabradine orally twice daily with food. After 14 days of treatment, dosing will be reassessed. If there is insufficient symptom improvement, the Study Physician/Principal Investigator may increase the dose to 5 mg twice daily. Ivabradine will be prepared in 2.5 mg opaque capsules to maintain blinding.
PlaceboDrug
Participants will receive matching placebo capsules orally twice daily with food. Placebo dosing will follow the same schedule as the ivabradine intervention, including a corresponding dose increase when required to maintain blinding. Placebo will be prepared in opaque capsules matching the ivabradine capsules.
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine followed by Placebo | Experimental | Participants randomized to this sequence receive ivabradine during the first treatment period, followed by a washout period, and then placebo during the second treatment period. Participants are independently re-randomized at the beginning of Cycle 2. Receives: Drug: Ivabradine; Drug: Placebo |
| Placebo followed by Ivabradine | Experimental | Participants randomized to this sequence receive placebo during the first treatment period, followed by a washout period, and then ivabradine during the second treatment period. Participants are independently re-randomized at the beginning of Cycle 2. Receives: Drug: Ivabradine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Resting Heart Rate (bpm) at end of 4-week treatment period.
Heart rate will be measured (ECG testing) before and after each 4-week treatment period. A decrease of greater than or equal to 10 beats per minute after 4 weeks of drug treatment will be considered clinically significant.
Measured: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Secondary outcomes (2)
Change from Baseline in Symptom Burden at end of 4-week treatment period.
Participants will identify 5 symptoms from a pre-defined list that are most disruptive to their day-to-day functioning. Individual symptoms will be rated for their frequency and severity using a 5-point Likert Scale from 0 = never or almost never have the symptom, to 4 = frequently have it, effect is severe. A decrease of 1 or more point on the Likert scale for 2 or more symptoms will be considered a meaningful response.
Measured: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Change from Baseline in Quality of Life Score as assessed by the PedsQL 4.0 at end of 4-week treatment period.
Quality of Life Score will be assessed using the Pediatric Quality of Life Inventory (PedsQL 4.0) questionnaire. Scores are on a scale of 0-100, where higher scores indicate a higher quality of life. An increase of 5 or more points in QoL Score will be considered clinically meaningful.
Measured: From baseline pre-treatment to the end of treatment at 4 weeks (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysautonomia of AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathryn Armstrong
- Sponsor type
- University, hospital or other
- Collaborators
- BC Children's Hospital Research Institute
- Responsible party
- Sponsor-investigator, Kathryn Armstrong, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881302
- Sponsor's protocol ID
- BCCH-IVA-001
- Acronym
- ADAPT
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study and underlying the results reported in publications may be made available to other researchers. Data will be shared in a manner that protects participant confidentiality and minimizes the risk of re-identification.