Long-Term Extension Period for Multiple System Atrophy

Neurostudies, Port Charlotte, FL
Multiple System Atrophy+1 More ConditionsAmpreloxetine - Drug
Eligibility
18+
All Sexes

Study Summary

This trial studies how well a drug helps treat Multiple System Atrophy with a form of dizziness. It has 4 steps and lasts 20 weeks.

Eligible Conditions
  • Neurogenic Orthostatic Hypotension
  • Multiple System Atrophy

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 8-week randomized withdrawal period (Week 12 to Week 20)

Week 20
Change from baseline in OHDAS item 1 (activities that require standing for a short time) at Week 8 post randomization
Change from baseline in OHDAS item 3 (activities that require walking for a short time) at Week 8 post randomization
Change in OHSA composite score at Week 8 during the double-blind RW period

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5 Treatment Groups

Long-Term Extension Period
1 of 5
Ampreloxetine (Open Label)
1 of 5
Ampreloxetine
1 of 5
Ampreloxetine (Randomized Withdrawal)
1 of 5
Placebo
1 of 5

Active Control

Non-Treatment Group

102 Total Participants · 5 Treatment Groups

Primary Treatment: Long-Term Extension Period · Has Placebo Group · Phase 3

Long-Term Extension Period
Drug
ActiveComparator Group · 1 Intervention: Ampreloxetine · Intervention Types: Drug
Ampreloxetine (Randomized Withdrawal)PlaceboComparator Group · 2 Interventions: Ampreloxetine, Placebo · Intervention Types: Drug, Drug
Ampreloxetine (Open Label)
Drug
ActiveComparator Group · 1 Intervention: Ampreloxetine · Intervention Types: Drug
Ampreloxetine
Drug
ActiveComparator Group · 1 Intervention: Ampreloxetine · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8-week randomized withdrawal period (week 12 to week 20)

Who is running the clinical trial?

Theravance BiopharmaLead Sponsor
73 Previous Clinical Trials
8,479 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
34 Patients Enrolled for Multiple System Atrophy

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Has the US Food & Drug Administration sanctioned a Long-Term Extension Period?

"The safety of the Long-Term Extension Period has been judged as a 3, owing to its Phase 3 trial status and existing efficacy data. Additionally, there are numerous studies that attest to its security." - Anonymous Online Contributor

Unverified Answer

Is this medical experiment actively looking for participants?

"As seen on clinicaltrials.gov, recruitment for this medical trial is ongoing; the first post was made on March 1st 2023 and most recently updated on March 30th of the same year." - Anonymous Online Contributor

Unverified Answer

How many volunteers are being recruited for this trial?

"Affirmative. According to information available on clinicaltrials.gov, this medical experiment was first published on March 1st 2023 and is actively enrolling participants at the moment. The study requires 102 individuals from a single trial location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.