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NCT04468191
Fatigue in Patients With Amyotrophic Lateral Sclerosis
NA trial testing Experimental expiratory muscle strength training (EMST) in Amyotrophic Lateral Sclerosis. Withdrawn.
10 February 2021
Quick facts
| Lead sponsor | Cara Donohue |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Start date | 10 February 2021 |
| Primary completion | 10 February 2021 |
| Estimated completion | 10 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Experimental expiratory muscle strength training (EMST)
- Sham expiratory muscle strength training (EMST)
Conditions studied
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
- Dysphagia — all drugs for Dysphagia →
- Dyspnea — all drugs for Dyspnea →
- Respiration Disorders — all drugs for Respiration Disorders →
Sponsor
Cara Donohue
Who can join
Adults 18 to 100, any sex, with Amyotrophic Lateral Sclerosis or Dysphagia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Expiratory muscle strength training (EMST) is an emerging palliative intervention for prolonging pulmonary and swallow function in patients with amyotrophic lateral sclerosis (PALS), but it is unknown whether EMST may result in detrimental immediate to short-term fatigue because there is no way to measure fatigue non-invasively. This study will determine the immediate to short-term impact of EMST on objective respiratory and swallow function, whether subjective ratings of dyspnea and fatigue map to objective decompensation of respiratory and swallow function, and the ability to monitor fatigue of the respiratory and swallowing musculature non-invasively. Findings from this research study will provide preliminary evidence regarding optimal timing for PALS to complete EMST and will provide PALS and clinicians increased capabilities to monitor fatigue non-invasively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04468191
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Amyotrophic Lateral Sclerosis
Currently open trials in the same condition.
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- NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
- NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04468191 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cara Donohue
- Last refreshed: 15 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04468191.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing