Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Prima… (NCT03829657) | Clinical Trial Compass
TerminatedPhase 3
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Stopped: Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.
United States203 participantsStarted 2019-02-22
Plain-language summary
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (For 0169 Completers Group):
* Subject has completed 4 weeks of double blind treatment in Study 0169 (V6) and, in the opinion of the Investigator, could benefit from continued treatment with ampreloxetine. Only subjects with OHSA#1 score of ≤7 will be eligible for randomization for the double-blind treatment period.
* Subject has a minimum of 80% study medication compliance in Study 0169.
Inclusion Criteria (For De Novo Group):
* Subject is male or female and at least 30 years old.
* Subject must meet the diagnostic criteria of symptomatic nOH, as demonstrated by a sustained reduction in BP of ≥20 mm Hg (systolic) or ≥10 mm Hg (diastolic) within 3 min of being tilted-up ≥60o from a supine position as determined by a tilt-table test.
* Subject must score at least a 4 on the OHSA#1 at V1.
* For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992).
* For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).
* For subjects with PAF only: Subject has documented impaired autonomic reflexes, including the Valsalva maneuver performed within 24 months from the date of randomization
* Subject has plasma Norepinephrine (NE) levels ≥ 100 pg/mL after being in seated position for 30 minutes.
Exclusion Criteria (For 0169 Completers Group):
* Subje…
What they're measuring
1
Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period
Timeframe: 6-week randomized withdrawal period (Week 16 to Week 22)