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Phase 2 Norepinephrine Transporter Blockade, Autonomic Failure IND117394 12/28/12 (NETAF)
Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic hypotension are scarce and not effective. If left untreated, these patients have the highest risk of syncope, falls and fall-related injuries. The proposed study will determine the clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated with neurogenic orthostatic hypotension in patients with autonomic failure.
Details
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 48 |
| Start date | 2016-08-29 |
| Completion | 2023-06 |
Conditions
- Neurogenic Orthostatic Hypotension
Interventions
- Atomoxetine
- Placebo
Primary outcomes
- Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score — week 0 to week 4
The Orthostatic Hypotension Questionnaire (OHQ) , patient-reported assessment tool consisting of the OH Symptom Assessment (OHSA), OH Daily Activity Scale (OHDAS). The composite score is composed of 10 individual items: 6 items measure specific symptoms , the Orthostatic Hypotension Symptom Assessment (OHSA), and 4 items measure the impact of those symptoms on a patient daily activities, the Orthostatic Hypotension Daily Activity Scale (OHDAS). This scales helps to measure the impact of orthostatic symptoms on daily. Scale is between 0-10: where "0" is minimum Orthostatic symptoms and "10" is the maximum / worse possible severity of the symptoms. All items are scored 0 through 10 (higher scores = more impact) and summed into the respective total scores. The OHSA and OHDAS subscales averaged to compute the OHQ composite score.
Countries
United States